Metastatic Small Intestinal AdenocarcinomaPhase 2NCT04205968
Ramucirumab and Paclitaxel or FOLFIRI in Advanced Small Bowel Cancers
A Phase 2 study testing Fluorouracil, Irinotecan and Irinotecan Hydrochloride in people with Metastatic Small Intestinal Adenocarcinoma and Stage III Small Intestinal Adenocarcinoma AJCC v8, run by SWOG Cancer Research Network at 536 sites in United States.
Trial summary
This phase II trial studies how well ramucirumab and paclitaxel or the FOLFIRI regimen (leucovorin calcium, fluorouracil, and irinotecan hydrochloride) work in treating patients with small bowel cancers that have spread extensively to other anatomic sites (advanced) or are no longer responding to treatment… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Small Intestinal Adenocarcinoma, Stage III Small Intestinal Adenocarcinoma AJCC v8, Stage IIIA Small Intestinal Adenocarcinoma AJCC v8
- What is being tested?
- Fluorouracil, Irinotecan and Irinotecan Hydrochloride
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 536 sitesUnited States
- Study dates
- 1 Jun 2020to 1 Aug 2027
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have histologically or cytologically confirmed small bowel adenocarcinoma. Ampullary adenocarcinomas are not eligible. Patients must have metastatic disease or locally advanced unresectable disease
- Brain metastases are allowed if they have been adequately treated with radiotherapy or surgery and stable for at least 30 days prior to registration. Patients must be neurologically asymptomatic and without corticosteroid treatment for at least 7 days prior to registration
- Patients must have measurable or non-measurable disease. All scans needed for assessment of measurable disease must be performed within 28 days prior to registration. Non-measurable disease must be assessed within 42 days prior to registration. All disease must be assessed and documented on the Baseline Tumor Assessment Form
- Patients must have progressed on prior therapy with a fluoropyrimidine and/or oxaliplatin, given either for metastatic/locally advanced disease or as adjuvant therapy completed within the previous 12 months
- Patients must have completed prior chemotherapy, immunotherapy, or radiation therapy at least 14 days prior to registration and all toxicity must be resolved to grade 1 (with the exception of grade 2 neuropathy) prior to registration. In Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 grade 2 sensory neuropathy is defined as "moderate symptoms; limiting instrumental activities of daily living (ADLs)"
- Patients must have a complete medical history and physical exam within 28 days prior to registration
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- Patients must have a Zubrod performance status of 0 or 1
- Absolute neutrophil count (ANC) >= 1,500/mcL (must be obtained within 28 days prior to registration)
- Platelets >= 100,000/mcL (must be obtained within 28 days prior to registration)
- A total bilirubin =< 1.5 x institutional limit normal (IULN) (must be obtained within 28 days prior to registration)
- Serum glutamic-oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) and serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 3.0 x IULN (or 5.0 x IULN if liver metastases are present) (must be obtained within 28 days prior to registration)
- Serum creatinine =< 1.5 x IULN OR calculated creatinine clearance >= 40 mL/min (must have been obtained within 28 days prior to registration)
- Patient must have urinary protein =< 1+ on dipstick or routine urinalysis (UA) within 28 days prior to registration. If dipstick or routine analysis is >= 2+, a 24 - hour urine collections for protein must demonstrate < 1000 mg of protein in 24 hours
- Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
- Patients must not have known dihydropyrimidine dehydrogenase deficiency
- Patients must be offered the opportunity to participate in specimen banking
- Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
Who cannot join
- Patients must not have received prior treatment with irinotecan, taxane, or ramucirumab for small bowel adenocarcinoma
- Patients must not have had major surgery within 28 days prior to registration, or minor surgery within 7 days prior to registration, and must not be planned for elective major surgery to be performed during protocol treatment
- Patients must not be currently enrolled in or have discontinued within the last 28 days a clinical trial involving an investigational product or non-approved use of a drug, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study. Patients participating in surveys or observational studies are eligible to participate in this study
- Patients must not be receiving chronic antiplatelet therapy, including dipyridamole or clopidogrel, or similar agents
- Patient must not have a known bleeding diathesis
- Patient must not have uncontrolled or poorly-controlled hypertension (> 160 mmHg systolic or > 100 mg HG diastolic for > 4 weeks) despite standard medical management
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- Patient tumors must not have known deficient mismatch repair (dMMR) or microsatellite instability high (MSI-H)
- Patients must not be pregnant or nursing and must have had a negative pregnancy test within 4 weeks of starting treatment. Women/men of reproductive potential must have agreed to use an effective contraceptive method. A woman is considered to be of "reproductive potential" if she has had menses at any time in the preceding 12 consecutive months. In addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation. However, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures
- Patients must not have an active infection requiring systemic therapy
- Patient must not have liver dysfunctions manifested by either (1) Child-Pugh B (or worse) or (2) cirrhosis (any degree) and a history of hepatic encephalopathy or clinically meaningful ascites resulting from cirrhosis. Clinically meaningful ascites is defined as ascites from cirrhosis requiring diuretics or paracentesis
- Patients must not have a history of deep vein thrombosis (DVT), pulmonary embolism (PE), or any other significant thromboembolism (venous port or catheter thrombosis or superficial venous thrombosis are not considered "significant") during the 90 days prior to registration
- Patients must not have experienced any arterial thrombotic event (including but not limited to myocardial infarction, unstable angina, stable angina markedly limiting ordinary physical activity, cerebrovascular accident, or transient ischemic attack) within 120 days prior to registration
- Patients must not have a prior history of gastrointestinal (GI) perforation/fistula or other risk factors for perforation within 120 days prior to registration
- Patients must not have experienced any grade 3-4 GI bleeding within 90 days prior to registration
- Patient must not have experienced any serious or non-healing wound, ulcer, or bone fracture within 28 days prior to registration
Trial locations and contacts
536 sites in 1 country. Contact the study team or a site near you to ask about taking part.
300 sites in 1 country
United States300 sites, 224 recruiting
- Recruiting
Providence Regional Cancer System-Aberdeen
Aberdeen, Washington, 98520
Site Public Contact, 360-412-8958, deidre.dillon@providence.org
Charles W. Drescher
- Suspended
Hickman Cancer Center
Adrian, Michigan, 49221
- Recruiting
Riverwood Healthcare Center
Aitkin, Minnesota, 56431
Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org
Bret E. Friday
- Recruiting
Atrium Health Stanly/LCI-Albemarle
Albemarle, North Carolina, 28002
Site Public Contact, 800-804-9376
Mohamed E. Salem
- Recruiting
Lehigh Valley Hospital-Cedar Crest
Allentown, Pennsylvania, 18103
Site Public Contact, 610-402-9543, Morgan_M.Horton@lvhn.org
Christopher M. Reynolds
- Recruiting
MyMichigan Medical Center Gratiot
Alma, Michigan, 48801
Site Public Contact, 989-631-2469, CVResearch@mymichigan.org
Christopher M. Reynolds
- Recruiting
MyMichigan Medical Center Alpena
Alpena, Michigan, 49707
Site Public Contact, 989-631-2469, CVResearch@mymichigan.org
Christopher M. Reynolds
- Recruiting
OSF Saint Anthony's Health Center
Alton, Illinois, 62002
Site Public Contact, 618-463-5623
Jay W. Carlson
- Active, not recruiting
Mary Greeley Medical Center
Ames, Iowa, 50010
- Active, not recruiting
McFarland Clinic - Ames
Ames, Iowa, 50010
- Recruiting
Community Hospital of Anaconda
Anaconda, Montana, 59711
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
- Recruiting
Kaiser Permanente-Anaheim
Anaheim, California, 92806
Site Public Contact, 800-398-3996, clinical.trials@kp.org
Gary L. Buchschacher
- Recruiting
Anchorage Associates in Radiation Medicine
Anchorage, Alaska, 98508
Site Public Contact, 907-212-6871, AKPAMC.OncologyResearchSupport@providence.org
Charles W. Drescher
- Suspended
Anchorage Radiation Therapy Center
Anchorage, Alaska, 99504
- Recruiting
Alaska Breast Care and Surgery LLC
Anchorage, Alaska, 99508
Site Public Contact, 907-212-6871, AKPAMC.OncologyResearchSupport@providence.org
Charles W. Drescher
- Recruiting
Alaska Oncology and Hematology LLC
Anchorage, Alaska, 99508
Site Public Contact, 907-212-6871, AKPAMC.OncologyResearchSupport@providence.org
Charles W. Drescher
- Recruiting
Alaska Women's Cancer Care
Anchorage, Alaska, 99508
Site Public Contact, 907-212-6871, AKPAMC.OncologyResearchSupport@providence.org
Charles W. Drescher
- Suspended
Anchorage Oncology Centre
Anchorage, Alaska, 99508
- Recruiting
Katmai Oncology Group
Anchorage, Alaska, 99508
Site Public Contact, 907-212-6871, AKPAMC.OncologyResearchSupport@providence.org
Charles W. Drescher
- Recruiting
Providence Alaska Medical Center
Anchorage, Alaska, 99508
Site Public Contact, 907-212-6871, AKPAMC.OncologyResearchSupport@providence.org
Charles W. Drescher
- Recruiting
UI Health Care Mission Cancer and Blood - Ankeny Clinic
Ankeny, Iowa, 50023
Site Public Contact, 515-241-3305
Richard L. Deming
- Recruiting
Trinity Health Saint Joseph Mercy Hospital Ann Arbor
Ann Arbor, Michigan, 48106
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Christopher M. Reynolds
- Recruiting
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109
Site Public Contact, slusserb@med.umich.edu
Arathi Mohan
- Active, not recruiting
Mission Hope Medical Oncology - Arroyo Grande
Arroyo Grande, California, 93420
- Recruiting
PCR Oncology
Arroyo Grande, California, 93420
Site Public Contact, 702-384-0013, research@sncrf.org
John A. Ellerton
- Recruiting
Duluth Clinic Ashland
Ashland, Wisconsin, 54806
Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org
Bret E. Friday
- Recruiting
Northwest Wisconsin Cancer Center
Ashland, Wisconsin, 54806
Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org
Bret E. Friday
- Recruiting
Rush-Copley Medical Center
Aurora, Illinois, 60504
Site Public Contact, 630-978-6212, RCMC_Cancer_Research@rush.edu
Kendrith M. Rowland
- Recruiting
Saint Alphonsus Cancer Care Center-Baker City
Baker City, Oregon, 97814
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
Christopher M. Reynolds
- Recruiting
Kaiser Permanente-Baldwin Park
Baldwin Park, California, 91706
Site Public Contact, 800-398-3996, clinical.trials@kp.org
Gary L. Buchschacher
- Recruiting
Mercy Oncology and Hematology - Clayton-Clarkson
Ballwin, Missouri, 63011
Site Public Contact, 888-446-3729
Jay W. Carlson
- Active, not recruiting
Flaget Memorial Hospital
Bardstown, Kentucky, 40004
- Recruiting
Bronson Battle Creek
Battle Creek, Michigan, 49017
Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org
Kathleen Y. Butler
- Recruiting
Essentia Health - Baxter Clinic
Baxter, Minnesota, 56425
Site Public Contact, 218-828-2880
Bret E. Friday
- Active, not recruiting
Indu and Raj Soin Medical Center
Beavercreek, Ohio, 45431
- Suspended
Overlake Medical Center
Bellevue, Washington, 98004
- Recruiting
Kaiser Permanente-Bellflower
Bellflower, California, 90706
Site Public Contact, 800-398-3996, clinical.trials@kp.org
Gary L. Buchschacher
- Recruiting
PeaceHealth Saint Joseph Medical Center
Bellingham, Washington, 98225
Site Public Contact, 360-788-8223
Charles W. Drescher
- Recruiting
Saint Charles Health System
Bend, Oregon, 97701
Site Public Contact, 541-706-2909, nosall@stcharleshealthcare.org
Charles W. Drescher
- Recruiting
Lehigh Valley Hospital - Muhlenberg
Bethlehem, Pennsylvania, 18017
Site Public Contact, 610-402-9543, Morgan_M.Horton@lvhn.org
Christopher M. Reynolds
- Recruiting
University of Iowa Healthcare Cancer Services Quad Cities
Bettendorf, Iowa, 52722
Site Public Contact, 563-355-7733, katherine-daprile@uiowa.edu
Saima Sharif
- Recruiting
Billings Clinic Cancer Center
Billings, Montana, 59101
Site Public Contact, 800-996-2663, research@billingsclinic.org
John M. Schallenkamp
- Recruiting
Saint Vincent Healthcare
Billings, Montana, 59101
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
Patrick W. Cobb
- Recruiting
Saint Vincent Frontier Cancer Center
Billings, Montana, 59102
Site Public Contact, 800-648-6274
Patrick W. Cobb
- Recruiting
Intermountain Health West End Clinic
Billings, Montana, 59106
Site Public Contact, 406-238-6685
Patrick W. Cobb
- Recruiting
Illinois CancerCare-Bloomington
Bloomington, Illinois, 61704
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Active, not recruiting
Saint Elizabeth Boardman Hospital
Boardman, Ohio, 44512
- Recruiting
Prisma Health Cancer Institute - Spartanburg
Boiling Springs, South Carolina, 29316
Site Public Contact, 864-522-4317, Kim.Williams3@prismahealth.org
Ki Y. Chung
- Recruiting
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho, 83706
Site Public Contact, 734-712-3671, stephanie.couch@stjoeshealth.org
Christopher M. Reynolds
- Recruiting
Saint Luke's Cancer Institute - Boise
Boise, Idaho, 83712
Site Public Contact, 208-381-2774, eslinget@slhs.org
Charles W. Drescher
- Recruiting
Central Care Cancer Center - Bolivar
Bolivar, Missouri, 65613
Site Public Contact, 913-948-5588, aroland@kccop.org
Jay W. Carlson
- Active, not recruiting
McFarland Clinic - Boone
Boone, Iowa, 50036
- Recruiting
Bozeman Health Deaconess Hospital
Bozeman, Montana, 59715
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
- Recruiting
Essentia Health Saint Joseph's Medical Center
Brainerd, Minnesota, 56401
Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org
Bret E. Friday
- Recruiting
Cox Cancer Center Branson
Branson, Missouri, 65616
Site Public Contact, 417-269-4520
Jay W. Carlson
- Recruiting
Lafayette Family Cancer Center-EMMC
Brewer, Maine, 04412
Site Public Contact, 800-987-3005
Sarah J. Sinclair
- Recruiting
Trinity Health IHA Medical Group Hematology Oncology - Brighton
Brighton, Michigan, 48114
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Christopher M. Reynolds
- Recruiting
Trinity Health Medical Center - Brighton
Brighton, Michigan, 48114
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Christopher M. Reynolds
- Suspended
University of Michigan - Brighton Center for Specialty Care
Brighton, Michigan, 48116
- Recruiting
Henry Ford Cancer Institute-Downriver
Brownstown, Michigan, 48183
Site Public Contact, 313-916-3721, CTOResearch@hfhs.org
Gazala Khan
- Active, not recruiting
Saint Joseph Regional Cancer Center
Bryan, Texas, 77802
- Active, not recruiting
Roswell Park Cancer Institute
Buffalo, New York, 14263
- Recruiting
Providence Saint Joseph Medical Center/Disney Family Cancer Center
Burbank, California, 91505
Site Public Contact, 818-847-4793, Najee.Boucher@providence.org
Charles W. Drescher
- Active, not recruiting
Highline Medical Center-Main Campus
Burien, Washington, 98166
- Suspended
Fairview Ridges Hospital
Burnsville, Minnesota, 55337
- Recruiting
Minnesota Oncology - Burnsville
Burnsville, Minnesota, 55337
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
David M. King
- Recruiting
Saint James Community Hospital and Cancer Treatment Center
Butte, Montana, 59701
Site Public Contact, 406-723-2621
Patrick W. Cobb
- Recruiting
Saint Alphonsus Cancer Care Center-Caldwell
Caldwell, Idaho, 83605
Site Public Contact, 734-712-3671, stephanie.couch@stjoeshealth.org
Christopher M. Reynolds
- Recruiting
Cambridge Medical Center
Cambridge, Minnesota, 55008
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
David M. King
- Recruiting
Illinois CancerCare-Canton
Canton, Illinois, 61520
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
Trinity Health IHA Medical Group Hematology Oncology - Canton
Canton, Michigan, 48188
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Christopher M. Reynolds
- Recruiting
Trinity Health Medical Center - Canton
Canton, Michigan, 48188
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Christopher M. Reynolds
- Recruiting
Mercy Cancer Center - Cape Girardeau
Cape Girardeau, Missouri, 63703
Site Public Contact, 888-446-3729
Jay W. Carlson
- Recruiting
Saint Francis Medical Center
Cape Girardeau, Missouri, 63703
Site Public Contact, 573-334-2230, sfmc@sfmc.net
Bryan A. Faller
- Recruiting
Memorial Hospital of Carbondale
Carbondale, Illinois, 62902
Site Public Contact, 618-457-5200, clinical.research@sih.net
Bryan A. Faller
- Active, not recruiting
Mercy Cancer Center - Carmichael
Carmichael, California, 95608
- Active, not recruiting
Mercy San Juan Medical Center
Carmichael, California, 95608
- Suspended
Caro Cancer Center
Caro, Michigan, 48723
- Recruiting
Saint Anthony Regional Hospital
Carroll, Iowa, 51401
Site Public Contact, 515-689-7658, sbenson@iora.org
Seema Harichand-Herdt
- Recruiting
Carson Tahoe Regional Medical Center
Carson City, Nevada, 89703
Site Public Contact, 702-384-0013, research@sncrf.org
John A. Ellerton
- Recruiting
SIH Cancer Institute
Carterville, Illinois, 62918
Site Public Contact, 618-985-3333, clinical.research@sih.net
Bryan A. Faller
- Recruiting
Illinois CancerCare-Carthage
Carthage, Illinois, 62321
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
Duke Cancer Center Cary
Cary, North Carolina, 27518
Site Public Contact, NCTNStudyTeam@dm.duke.edu
Aman Opneja
- Active, not recruiting
Dayton Physicians LLC-Miami Valley South
Centerville, Ohio, 45459
- Suspended
Miami Valley Hospital South
Centerville, Ohio, 45459
- Recruiting
Centralia Oncology Clinic
Centralia, Illinois, 62801
Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com
Bryan A. Faller
- Recruiting
Saint Mary's Hospital
Centralia, Illinois, 62801
Site Public Contact, protocols@swog.org
Jay W. Carlson
- Recruiting
Providence Regional Cancer System-Centralia
Centralia, Washington, 98531
Site Public Contact, 360-412-8958, deidre.dillon@providence.org
Charles W. Drescher
- Recruiting
Carolinas Medical Center/Levine Cancer Institute
Charlotte, North Carolina, 28203
Site Public Contact, 800-804-9376
Mohamed E. Salem
- Recruiting
Atrium Health Pineville/LCI-Pineville
Charlotte, North Carolina, 28210
Site Public Contact, 980-442-2000
Mohamed E. Salem
- Recruiting
Levine Cancer Institute-SouthPark
Charlotte, North Carolina, 28211
Site Public Contact, 980-442-2000
Mohamed E. Salem
- Recruiting
Atrium Health University City/LCI-University
Charlotte, North Carolina, 28262
Site Public Contact, 800-804-9376
Mohamed E. Salem
- Recruiting
Chelsea Hospital
Chelsea, Michigan, 48118
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Christopher M. Reynolds
- Recruiting
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
Chelsea, Michigan, 48118
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Christopher M. Reynolds
- Active, not recruiting
Northwestern University
Chicago, Illinois, 60611
- Recruiting
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, 60637
Site Public Contact, 773-702-8222, cancerclinicaltrials@bsd.uchicago.edu
Ardaman Shergill
- Recruiting
Marshfield Clinic-Chippewa Center
Chippewa Falls, Wisconsin, 54729
Site Public Contact, 800-782-8581, oncology.clinical.trials@marshfieldresearch.org
Chady A. Leon
- Active, not recruiting
Good Samaritan Hospital - Cincinnati
Cincinnati, Ohio, 45220
- Active, not recruiting
Oncology Hematology Care Inc-Kenwood
Cincinnati, Ohio, 45236
- Active, not recruiting
Bethesda North Hospital
Cincinnati, Ohio, 45242
- Active, not recruiting
TriHealth Cancer Institute-Westside
Cincinnati, Ohio, 45247
- Active, not recruiting
TriHealth Cancer Institute-Anderson
Cincinnati, Ohio, 45255
- Active, not recruiting
Siteman Cancer Center at Saint Peters Hospital
City of Saint Peters, Missouri, 63376
- Recruiting
Clackamas Radiation Oncology Center
Clackamas, Oregon, 97015
Site Public Contact, 503-215-2614, CanRsrchStudies@providence.org
Charles W. Drescher
- Suspended
Providence Cancer Institute Clackamas Clinic
Clackamas, Oregon, 97015
- Recruiting
Hematology Oncology Consultants-Clarkston
Clarkston, Michigan, 48346
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Christopher M. Reynolds
- Recruiting
Newland Medical Associates-Clarkston
Clarkston, Michigan, 48346
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Christopher M. Reynolds
- Recruiting
Henry Ford Macomb Hospital-Clinton Township
Clinton Township, Michigan, 48038
Site Public Contact, 313-916-3721, CTOResearch@hfhs.org
Gazala Khan
- Recruiting
Mercy Cancer Center-West Lakes
Clive, Iowa, 50325
Site Public Contact, 515-358-6613, cancerresearch@mercydesmoines.org
Richard L. Deming
- Recruiting
UI Health Care Mission Cancer and Blood - West Des Moines Clinic
Clive, Iowa, 50325
Site Public Contact, 515-241-3305
Seema Harichand-Herdt
- Recruiting
Billings Clinic-Cody
Cody, Wyoming, 82414
Site Public Contact, 800-996-2663, research@billingsclinic.org
John M. Schallenkamp
- Recruiting
Kootenai Health - Coeur d'Alene
Coeur d'Alene, Idaho, 83814
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
- Recruiting
Baptist Memorial Hospital and Cancer Center-Collierville
Collierville, Tennessee, 38017
Site Public Contact, 901-226-1366, BCCclintrials@bmhcc.org
Aleksandar Jankov
- Active, not recruiting
Penrose-Saint Francis Healthcare
Colorado Springs, Colorado, 80907
- Active, not recruiting
Rocky Mountain Cancer Centers-Penrose
Colorado Springs, Colorado, 80907
- Active, not recruiting
Saint Francis Cancer Center
Colorado Springs, Colorado, 80923
- Recruiting
Atrium Health Cabarrus/LCI-Concord
Concord, North Carolina, 28025
Site Public Contact, 800-804-9376
Mohamed E. Salem
- Recruiting
Mercy Hospital
Coon Rapids, Minnesota, 55433
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
David M. King
- Recruiting
Bay Area Hospital
Coos Bay, Oregon, 97420
Site Public Contact, 541-269-8392, cherie.cox@bayareahospital.org
Charles W. Drescher
- Active, not recruiting
Commonwealth Cancer Center-Corbin
Corbin, Kentucky, 40701
- Active, not recruiting
Alegent Health Mercy Hospital
Council Bluffs, Iowa, 51503
- Recruiting
Greater Regional Medical Center
Creston, Iowa, 50801
Site Public Contact, 515-358-6613, cancerresearch@mercydesmoines.org
Richard L. Deming
- Active, not recruiting
Siteman Cancer Center at West County Hospital
Creve Coeur, Missouri, 63141
- Recruiting
Essentia Health - Saint Joseph's Crosslake Clinic
Crosslake, Minnesota, 56442
Site Public Contact, 218-692-1010
Bret E. Friday
- Active, not recruiting
Parkland Memorial Hospital
Dallas, Texas, 75235
- Active, not recruiting
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, 75390
- Recruiting
Carle at The Riverfront
Danville, Illinois, 61832
Site Public Contact, 800-446-5532, Research@Carle.com
Kendrith M. Rowland
- Suspended
Miami Valley Hospital
Dayton, Ohio, 45409
- Active, not recruiting
Dayton Physician LLC - Englewood
Dayton, Ohio, 45415
- Suspended
Miami Valley Hospital North
Dayton, Ohio, 45415
- Recruiting
Henry Ford Medical Center-Fairlane
Dearborn, Michigan, 48126
Site Public Contact, 313-916-3721, CTOResearch@hfhs.org
Gazala Khan
- Recruiting
Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois, 62526
Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com
Bryan A. Faller
- Recruiting
Decatur Memorial Hospital
Decatur, Illinois, 62526
Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com
Bryan A. Faller
- Recruiting
Essentia Health - Deer River Clinic
Deer River, Minnesota, 56636
Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org
Bret E. Friday
- Recruiting
Cancer Center of Colorado at Sloan's Lake
Denver, Colorado, 80204
Site Public Contact, 303-777-2663
Patrick W. Cobb
- Recruiting
National Jewish Health-Main Campus
Denver, Colorado, 80206
Site Public Contact, 877-225-5654, glicht@co-cancerresearch.org
Patrick W. Cobb
- Active, not recruiting
AdventHealth Porter
Denver, Colorado, 80210
- Recruiting
Saint Joseph Hospital - Cancer Centers of Colorado
Denver, Colorado, 80218
Site Public Contact, 303-318-3413
Patrick W. Cobb
- Recruiting
Smilow Cancer Hospital-Derby Care Center
Derby, Connecticut, 06418
Site Public Contact, 203-785-5702, canceranswers@yale.edu
Stephen C. Lattanzi
- Recruiting
Iowa Methodist Medical Center
Des Moines, Iowa, 50309
Site Public Contact, 515-241-6727
Seema Harichand-Herdt
- Recruiting
UI Health Care Mission Cancer and Blood - Des Moines Clinic
Des Moines, Iowa, 50309
Site Public Contact, 515-241-3305
Seema Harichand-Herdt
- Recruiting
Broadlawns Medical Center
Des Moines, Iowa, 50314
Site Public Contact, 515-282-2200
Seema Harichand-Herdt
- Recruiting
Mercy Medical Center - Des Moines
Des Moines, Iowa, 50314
Site Public Contact, 515-358-6613, cancerresearch@mercydesmoines.org
Richard L. Deming
- Recruiting
UI Health Care Mission Cancer and Blood - Laurel Clinic
Des Moines, Iowa, 50314
Site Public Contact, 515-241-3305
Seema Harichand-Herdt
- Recruiting
Iowa Lutheran Hospital
Des Moines, Iowa, 50316
Site Public Contact, 515-241-8704
Seema Harichand-Herdt
- Active, not recruiting
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan, 48201
- Recruiting
Henry Ford Hospital
Detroit, Michigan, 48202
Site Public Contact, 313-916-3721, CTOResearch@hfhs.org
Gazala Khan
- Recruiting
Henry Ford Health Saint John Hospital
Detroit, Michigan, 48236
Site Public Contact, 313-343-3166, Kkeenan1@hfhs.org
Christopher M. Reynolds
- Recruiting
Essentia Health Saint Mary's - Detroit Lakes Clinic
Detroit Lakes, Minnesota, 56501
Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org
Bret E. Friday
- Recruiting
Illinois CancerCare-Dixon
Dixon, Illinois, 61021
Site Public Contact, 815-285-7800
Bryan A. Faller
- Recruiting
Essentia Health Cancer Center
Duluth, Minnesota, 55805
Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org
Bret E. Friday
- Recruiting
Essentia Health Saint Mary's Medical Center
Duluth, Minnesota, 55805
Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org
Bret E. Friday
- Recruiting
Miller-Dwan Hospital
Duluth, Minnesota, 55805
Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org
Bret E. Friday
- Active, not recruiting
CommonSpirit Cancer Center Mercy
Durango, Colorado, 81301
- Active, not recruiting
Mercy Medical Center
Durango, Colorado, 81301
- Recruiting
Duke University Medical Center
Durham, North Carolina, 27710
Site Public Contact, 888-275-3853
Aman Opneja
- Recruiting
Prisma Health Cancer Institute - Easley
Easley, South Carolina, 29640
Site Public Contact, 864-522-4317, Kim.Williams3@prismahealth.org
Ki Y. Chung
- Recruiting
Henry Ford River District Hospital
East China, Michigan, 48054
Site Public Contact, 313-343-3166, kforman1@hfhs.org
Christopher M. Reynolds
- Recruiting
Pocono Medical Center
East Stroudsburg, Pennsylvania, 18301
Site Public Contact, 610-402-9543, Morgan_M.Horton@lvhn.org
Christopher M. Reynolds
- Recruiting
Marshfield Medical Center-EC Cancer Center
Eau Claire, Wisconsin, 54701
Site Public Contact, 800-782-8581, oncology.clinical.trials@marshfieldresearch.org
Chady A. Leon
- Recruiting
Fairview Southdale Hospital
Edina, Minnesota, 55435
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
David M. King
- Recruiting
Swedish Cancer Institute-Edmonds
Edmonds, Washington, 98026
Site Public Contact, 206-215-2343, PCRC-NCORP@Swedish.org
Charles W. Drescher
- Recruiting
Carle Physician Group-Effingham
Effingham, Illinois, 62401
Site Public Contact, 800-446-5532, Research@carle.com
Kendrith M. Rowland
- Recruiting
Crossroads Cancer Center
Effingham, Illinois, 62401
Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com
Bryan A. Faller
- Active, not recruiting
Mercy Cancer Center - Elk Grove
Elk Grove, California, 95758
- Recruiting
Essentia Health - Ely Clinic
Ely, Minnesota, 55731
Site Public Contact, 218-365-7900
Bret E. Friday
- Suspended
Walter Knox Memorial Hospital
Emmett, Idaho, 83617
- Active, not recruiting
Saint Elizabeth Hospital
Enumclaw, Washington, 98022
- Recruiting
Illinois CancerCare-Eureka
Eureka, Illinois, 61530
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
Providence Regional Cancer Partnership
Everett, Washington, 98201
Site Public Contact, 425-261-3529, marilyn.birchman@providence.org
Charles W. Drescher
- Recruiting
Smilow Cancer Hospital Care Center-Fairfield
Fairfield, Connecticut, 06824
Site Public Contact, 203-785-5702, canceranswers@yale.edu
Stephen C. Lattanzi
- Recruiting
Essentia Health Cancer Center-South University Clinic
Fargo, North Dakota, 58103
Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org
Bret E. Friday
- Recruiting
Parkland Health Center - Farmington
Farmington, Missouri, 63640
Site Public Contact, 314-996-5569
Bryan A. Faller
- Active, not recruiting
Weisberg Cancer Treatment Center
Farmington Hills, Michigan, 48334
- Active, not recruiting
Saint Francis Hospital
Federal Way, Washington, 98003
- Suspended
Lake Region Healthcare Corporation-Cancer Care
Fergus Falls, Minnesota, 56537
- Active, not recruiting
Armes Family Cancer Center
Findlay, Ohio, 45840
- Active, not recruiting
Blanchard Valley Hospital
Findlay, Ohio, 45840
- Active, not recruiting
Orion Cancer Care
Findlay, Ohio, 45840
- Recruiting
Cancer Hematology Centers - Flint
Flint, Michigan, 48503
Site Public Contact, 810-762-8038, wstrong@ghci.org
Christopher M. Reynolds
- Recruiting
Genesee Hematology Oncology PC
Flint, Michigan, 48503
Site Public Contact, 810-762-8038, wstrong@ghci.org
Christopher M. Reynolds
- Recruiting
Genesys Hurley Cancer Institute
Flint, Michigan, 48503
Site Public Contact, 810-762-8038, wstrong@ghci.org
Christopher M. Reynolds
- Recruiting
Hurley Medical Center
Flint, Michigan, 48503
Site Public Contact, 810-762-8038, wstrong@ghci.org
Christopher M. Reynolds
- Recruiting
Kaiser Permanente-Fontana
Fontana, California, 92335
Site Public Contact, 800-398-3996, clinical.trials@kp.org
Gary L. Buchschacher
- Active, not recruiting
McFarland Clinic - Trinity Cancer Center
Fort Dodge, Iowa, 50501
- Recruiting
UI Healthcare Mission Cancer and Blood - Fort Dodge
Fort Dodge, Iowa, 50501
Site Public Contact, 515-282-2921, trials@missioncancer.com
Seema Harichand-Herdt
- Recruiting
Holy Cross Hospital
Fort Lauderdale, Florida, 33308
Site Public Contact, eileen.georgi@holy-cross.com
Christopher M. Reynolds
- Active, not recruiting
Regional Cancer Center-Lee Memorial Health System
Fort Myers, Florida, 33905
- Recruiting
Mercy Hospital Fort Smith
Fort Smith, Arkansas, 72903
Site Public Contact, 800-378-9373
Jay W. Carlson
- Recruiting
Essentia Health - Fosston
Fosston, Minnesota, 56542
Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org
Bret E. Friday
- Suspended
Atrium Medical Center-Middletown Regional Hospital
Franklin, Ohio, 45005-1066
- Active, not recruiting
Dayton Physicians LLC-Atrium
Franklin, Ohio, 45005
- Active, not recruiting
Unity Hospital
Fridley, Minnesota, 55432
- Recruiting
Saint Luke's Cancer Institute - Fruitland
Fruitland, Idaho, 83619
Site Public Contact, 208-381-2774, eslinget@slhs.org
Charles W. Drescher
- Recruiting
Illinois CancerCare-Galesburg
Galesburg, Illinois, 61401
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Suspended
Western Illinois Cancer Treatment Center
Galesburg, Illinois, 61401
- Recruiting
Central Care Cancer Center - Garden City
Garden City, Kansas, 67846
Site Public Contact, 913-948-5588, aroland@kccop.org
Jay W. Carlson
- Recruiting
MyMichigan Medical Center Gladwin
Gladwin, Michigan, 48624
Site Public Contact, 989-631-2469, CVResearch@mymichigan.org
Christopher M. Reynolds
- Recruiting
National Jewish Health-Western Hematology Oncology
Golden, Colorado, 80401
Site Public Contact, 303-777-2663, glicht@co-cancerresearch.org
Patrick W. Cobb
- Suspended
Nebraska Cancer Specialists/Oncology Hematology West PC
Grand Island, Nebraska, 68803
- Recruiting
Saint Mary's Hospital and Regional Medical Center
Grand Junction, Colorado, 81501
Site Public Contact, 303-777-2663, ccrp@co-cancerresearch.org
Patrick W. Cobb
- Recruiting
Corewell Health Grand Rapids Hospitals - Butterworth Hospital
Grand Rapids, Michigan, 49503
Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org
Kathleen Y. Butler
- Recruiting
Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital
Grand Rapids, Michigan, 49503
Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org
Kathleen Y. Butler
- Recruiting
Trinity Health Grand Rapids Hospital
Grand Rapids, Michigan, 49503
Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org
Kathleen Y. Butler
- Recruiting
Central Care Cancer Center - Great Bend
Great Bend, Kansas, 67530
Site Public Contact, 913-948-5588, aroland@kccop.org
Jay W. Carlson
- Recruiting
Benefis Sletten Cancer Institute
Great Falls, Montana, 59405
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
- Recruiting
Great Falls Clinic
Great Falls, Montana, 59405
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
- Active, not recruiting
Dayton Physicians LLC-Wayne
Greenville, Ohio, 45331
- Active, not recruiting
Wayne Hospital
Greenville, Ohio, 45331
- Recruiting
Prisma Health Cancer Institute - Butternut
Greenville, South Carolina, 29605
Site Public Contact, 864-522-4317, Kim.Williams3@prismahealth.org
Ki Y. Chung
- Recruiting
Prisma Health Cancer Institute - Faris
Greenville, South Carolina, 29605
Site Public Contact, 864-522-4317, Kim.Williams3@prismahealth.org
Ki Y. Chung
- Active, not recruiting
Prisma Health Greenville Memorial Hospital
Greenville, South Carolina, 29605
- Recruiting
Prisma Health Cancer Institute - Eastside
Greenville, South Carolina, 29615
Site Public Contact, 864-522-4317, Kim.Williams3@prismahealth.org
Ki Y. Chung
- Recruiting
Smilow Cancer Hospital Care Center at Greenwich
Greenwich, Connecticut, 06830
Site Public Contact, 203-785-5702, canceranswers@yale.edu
Stephen C. Lattanzi
- Recruiting
Prisma Health Cancer Institute - Greer
Greer, South Carolina, 29650
Site Public Contact, 864-522-4317, Kim.Williams3@prismahealth.org
Ki Y. Chung
- Recruiting
Baptist Cancer Center-Grenada
Grenada, Mississippi, 38901
Site Public Contact, 901-226-1366, BCCclintrials@bmhcc.org
Aleksandar Jankov
- Recruiting
Henry Ford Saint John Hospital - Academic
Grosse Pointe Woods, Michigan, 48236
Site Public Contact, 313-343-3166, kforman1@hfhs.org
Christopher M. Reynolds
- Recruiting
Henry Ford Saint John Hospital - Breast
Grosse Pointe Woods, Michigan, 48236
Site Public Contact, 313-343-3166, karen.forman@ascension.org
Christopher M. Reynolds
- Recruiting
Henry Ford Saint John Hospital - Van Elslander
Grosse Pointe Woods, Michigan, 48236
Site Public Contact, 313-343-3166, kforman1@hfhs.org
Christopher M. Reynolds
- Recruiting
Smilow Cancer Hospital Care Center - Guilford
Guilford, Connecticut, 06437
Site Public Contact, 203-785-5702, canceranswers@yale.edu
Stephen C. Lattanzi
- Recruiting
Kaiser Permanente South Bay
Harbor City, California, 90710
Site Public Contact, 800-398-3996, clinical.trials@kp.org
Gary L. Buchschacher
- Recruiting
Smilow Cancer Hospital Care Center at Saint Francis
Hartford, Connecticut, 06105
Site Public Contact, 203-785-5702, canceranswers@yale.edu
Stephen C. Lattanzi
- Recruiting
Hi-Line Sletten Cancer Center
Havre, Montana, 59501
Site Public Contact, protocols@swog.org
John M. Schallenkamp
- Recruiting
Essentia Health-Hayward Clinic
Hayward, Wisconsin, 54843
Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org
Bret E. Friday
- Recruiting
Tamarack Health Hayward Medical Center
Hayward, Wisconsin, 54843
Site Public Contact, 218-568-4416
Bret E. Friday
- Recruiting
Lehigh Valley Hospital-Hazleton
Hazleton, Pennsylvania, 18201
Site Public Contact, 610-402-9543, Morgan_M.Horton@lvhn.org
Christopher M. Reynolds
- Recruiting
Cancer and Blood Specialists-Henderson
Henderson, Nevada, 89052
Site Public Contact, 702-384-0013, research@sncrf.org
John A. Ellerton
- Recruiting
Comprehensive Cancer Centers of Nevada - Henderson
Henderson, Nevada, 89052
Site Public Contact, 702-384-0013, research@sncrf.org
John A. Ellerton
- Recruiting
Comprehensive Cancer Centers of Nevada-Horizon Ridge
Henderson, Nevada, 89052
Site Public Contact, 702-384-0013, research@sncrf.org
John A. Ellerton
- Suspended
Las Vegas Cancer Center-Henderson
Henderson, Nevada, 89052
- Recruiting
OptumCare Cancer Care at Seven Hills
Henderson, Nevada, 89052
Site Public Contact, 702-384-0013, research@sncrf.org
John A. Ellerton
- Recruiting
Comprehensive Cancer Centers of Nevada-Southeast Henderson
Henderson, Nevada, 89074
Site Public Contact, 702-384-0013, research@sncrf.org
John A. Ellerton
- Recruiting
Las Vegas Urology - Green Valley
Henderson, Nevada, 89074
Site Public Contact, research@sncrf.org
John A. Ellerton
- Recruiting
Las Vegas Urology - Pebble
Henderson, Nevada, 89074
Site Public Contact, research@sncrf.org
John A. Ellerton
- Recruiting
Oncology Las Vegas - Henderson
Henderson, Nevada, 89074
Site Public Contact, 702-384-0013, research@sncrf.org
John A. Ellerton
- Recruiting
Urology Specialists of Nevada - Green Valley
Henderson, Nevada, 89074
Site Public Contact, research@sncrf.org
John A. Ellerton
- Recruiting
Essentia Health Hibbing Clinic
Hibbing, Minnesota, 55746
Site Public Contact, 218-786-3308
Bret E. Friday
- Recruiting
Providence Hood River Memorial Hospital
Hood River, Oregon, 97031
Site Public Contact, 503-215-1979, canrsrchstudies@provdience.org
Charles W. Drescher
- Suspended
CHI Saint Vincent Cancer Center Hot Springs
Hot Springs, Arkansas, 71913
- Recruiting
M D Anderson Cancer Center
Houston, Texas, 77030
Site Public Contact, 877-632-6789, askmdanderson@mdanderson.org
Michael J. Overman
- Recruiting
Essentia Health - International Falls Clinic
International Falls, Minnesota, 56649
Site Public Contact, 218-283-9431
Bret E. Friday
- Recruiting
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242
Site Public Contact, 800-237-1225
Saima Sharif
- Recruiting
Kaiser Permanente-Irvine
Irvine, California, 92618
Site Public Contact, 800-398-3996, clinical.trials@kp.org
Gary L. Buchschacher
- Recruiting
Swedish Cancer Institute-Issaquah
Issaquah, Washington, 98029
Site Public Contact, 206-215-2343, PCRC-NCORP@Swedish.org
Charles W. Drescher
- Recruiting
Allegiance Health
Jackson, Michigan, 49201
Site Public Contact, 313-916-3721, CTOResearch@hfhs.org
Gazala Khan
- Recruiting
Essentia Health - Jamestown Clinic
Jamestown, North Dakota, 58401
Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org
Bret E. Friday
- Active, not recruiting
McFarland Clinic - Jefferson
Jefferson, Iowa, 50129
- Suspended
MU Health Care Goldschmidt Cancer Center
Jefferson City, Missouri, 65109
- Recruiting
NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
Jonesboro, Arkansas, 72401
Site Public Contact, 870-936-7066, Emily.Carvell@bmhcc.org
Aleksandar Jankov
- Recruiting
Freeman Health System
Joplin, Missouri, 64804
Site Public Contact, 417-347-4030, LJCrockett@freemanhealth.com
Jay W. Carlson
- Recruiting
Mercy Hospital Joplin
Joplin, Missouri, 64804
Site Public Contact, 417-556-3074, esmeralda.carrillo@mercy.net
Jay W. Carlson
- Recruiting
Bronson Methodist Hospital
Kalamazoo, Michigan, 49007
Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org
Kathleen Y. Butler
- Recruiting
West Michigan Cancer Center
Kalamazoo, Michigan, 49007
Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org
Kathleen Y. Butler
- Recruiting
Beacon Kalamazoo Cancer Center
Kalamazoo, Michigan, 49009
Site Public Contact, 574-647-7370
Kathleen Y. Butler
- Recruiting
Beacon Kalamazoo
Kalamazoo, Michigan, 49048
Site Public Contact, 574-647-7370
Kathleen Y. Butler
- Recruiting
Logan Health Medical Center
Kalispell, Montana, 59901
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
- Active, not recruiting
CHI Health Good Samaritan
Kearney, Nebraska, 68847
- Recruiting
Kadlec Clinic Hematology and Oncology
Kennewick, Washington, 99336
Site Public Contact, 509-783-4637, research@kadlecmed.org
Charles W. Drescher
- Active, not recruiting
Greater Dayton Cancer Center
Kettering, Ohio, 45409
- Suspended
First Dayton Cancer Care
Kettering, Ohio, 45420
- Active, not recruiting
Kettering Medical Center
Kettering, Ohio, 45429
- Recruiting
Illinois CancerCare-Kewanee Clinic
Kewanee, Illinois, 61443
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
Kingman Regional Medical Center
Kingman, Arizona, 86401
Site Public Contact, 702-384-0013, research@sncrf.org
John A. Ellerton
- Recruiting
Providence Regional Cancer System-Lacey
Lacey, Washington, 98503
Site Public Contact, 360-412-8958, deidre.dillon@providence.org
Charles W. Drescher
- Recruiting
Marshfield Medical Center - Ladysmith
Ladysmith, Wisconsin, 54848
Site Public Contact, 800-782-8581, oncology.clinical.trials@marshfieldresearch.org
Chady A. Leon
- Recruiting
Good Samaritan Hospital - Cancer Centers of Colorado
Lafayette, Colorado, 80026
Site Public Contact, peaksresearch@imail.org
Patrick W. Cobb
- Active, not recruiting
Northwestern Medicine Lake Forest Hospital
Lake Forest, Illinois, 60045
- Active, not recruiting
Saint Anthony Hospital
Lakewood, Colorado, 80228
- Active, not recruiting
Saint Clare Hospital
Lakewood, Washington, 98499
- Recruiting
University of Michigan Health - Sparrow Lansing
Lansing, Michigan, 48912
Site Public Contact, 517-364-3712, harsha.trivedi@umhsparrow.org
Christopher M. Reynolds
- Recruiting
Las Vegas Urology - Pecos
Las Vegas, Nevada, 89074
Site Public Contact, research@sncrf.org
John A. Ellerton
- Suspended
Desert West Surgery
Las Vegas, Nevada, 89102
- Recruiting
OptumCare Cancer Care at Charleston
Las Vegas, Nevada, 89102
Site Public Contact, 702-384-0013, research@sncrf.org
John A. Ellerton
- Recruiting
University Medical Center of Southern Nevada
Las Vegas, Nevada, 89102
Site Public Contact, 702-384-0013, research@sncrf.org
John A. Ellerton
- Recruiting
Hope Cancer Care of Nevada
Las Vegas, Nevada, 89103
Site Public Contact, 702-384-0013, research@sncrf.org
John A. Ellerton
- Recruiting
Radiation Oncology Centers of Nevada Central
Las Vegas, Nevada, 89106
Site Public Contact, 702-384-0013, research@sncrf.org
John A. Ellerton
- Recruiting
Urology Specialists of Nevada - Central
Las Vegas, Nevada, 89106
Site Public Contact, research@sncrf.org
John A. Ellerton
- Recruiting
Sunrise Hospital and Medical Center
Las Vegas, Nevada, 89109
Site Public Contact, 702-384-0013, research@sncrf.org
John A. Ellerton
- Recruiting
Las Vegas Prostate Cancer Center
Las Vegas, Nevada, 89113
Site Public Contact, research@sncrf.org
John A. Ellerton
- Recruiting
Las Vegas Urology - Sunset
Las Vegas, Nevada, 89113
Site Public Contact, research@sncrf.org
John A. Ellerton
- Recruiting
Urology Specialists of Nevada - Southwest
Las Vegas, Nevada, 89113
Site Public Contact, research@sncrf.org
John A. Ellerton
- Recruiting
Radiation Oncology Centers of Nevada Southeast
Las Vegas, Nevada, 89119
Site Public Contact, 702-384-0013, research@sncrf.org
John A. Ellerton
- Recruiting
Ann M Wierman MD LTD
Las Vegas, Nevada, 89128
Site Public Contact, 702-384-0013, research@sncrf.org
John A. Ellerton
- Recruiting
Comprehensive Cancer Centers of Nevada - Northwest
Las Vegas, Nevada, 89128
Site Public Contact, 702-384-0013, research@sncrf.org
John A. Ellerton
- Recruiting
Las Vegas Urology - Cathedral Rock
Las Vegas, Nevada, 89128
Site Public Contact, research@sncrf.org
John A. Ellerton
- Recruiting
Las Vegas Urology - Smoke Ranch
Las Vegas, Nevada, 89128
Site Public Contact, research@smcrf.org
John A. Ellerton
- Recruiting
Oncology Las Vegas - Tenaya
Las Vegas, Nevada, 89128
Site Public Contact, 702-384-0013, research@sncrf.org
John A. Ellerton
- Recruiting
OptumCare Cancer Care at MountainView
Las Vegas, Nevada, 89128
Site Public Contact, 702-384-0013, research@sncrf.org
John A. Ellerton
- Recruiting
Urology Specialists of Nevada - Northwest
Las Vegas, Nevada, 89128
Site Public Contact, research@sncrf.org
John A. Ellerton
- Recruiting
Alliance for Childhood Diseases/Cure 4 the Kids Foundation
Las Vegas, Nevada, 89135
Site Public Contact, 702-384-0013, research@sncrf.org
John A. Ellerton
- Recruiting
Comprehensive Cancer Centers of Nevada - Town Center
Las Vegas, Nevada, 89144
Site Public Contact, 702-384-0013, research@sncrf.org
John A. Ellerton
- Recruiting
Comprehensive Cancer Centers of Nevada-Summerlin
Las Vegas, Nevada, 89144
Site Public Contact, 702-384-0013, research@sncrf.org
John A. Ellerton
- Recruiting
Summerlin Hospital Medical Center
Las Vegas, Nevada, 89144
Site Public Contact, 702-384-0013, research@sncrf.org
John A. Ellerton
- Suspended
Las Vegas Cancer Center-Medical Center
Las Vegas, Nevada, 89148-2405
- Recruiting
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89148
Site Public Contact, 702-384-0013, research@sncrf.org
John A. Ellerton
- Recruiting
OptumCare Cancer Care at Fort Apache
Las Vegas, Nevada, 89148
Site Public Contact, 702-384-0013, research@sncrf.org
John A. Ellerton
- Recruiting
Comprehensive Cancer Centers of Nevada - Central Valley
Las Vegas, Nevada, 89169
Site Public Contact, 702-384-0013, research@sncrf.org
John A. Ellerton
- Recruiting
University Cancer Center
Las Vegas, Nevada, 89169
Site Public Contact, 702-384-0013, research@sncrf.org
John A. Ellerton
- Recruiting
Cancer Centers of Southwest Oklahoma Research
Lawton, Oklahoma, 73505
Site Public Contact, 877-231-4440
Hassan Hatoum
- Recruiting
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Lebanon, New Hampshire, 03756
Site Public Contact, 800-639-6918, cancer.research.nurse@dartmouth.edu
Kathryn C. Hourdequin
About this study
Official title: Randomized Phase II Selection Study of Ramucirumab and Paclitaxel Versus FOLFIRI in Refractory Small Bowel Adenocarcinoma
This phase II trial studies how well ramucirumab and paclitaxel or the FOLFIRI regimen (leucovorin calcium, fluorouracil, and irinotecan hydrochloride) work in treating patients with small bowel cancers that have spread extensively to other anatomic sites (advanced) or are no longer responding to treatment (refractory). Ramucirumab is a monoclonal antibody that attaches to and inhibits a molecule called VEGFR-2. This may restrain new blood vessel formation therefore reducing nutrient supply to tumor which may interfere with tumor cell growth and expansion. Drugs used in chemotherapy, such as paclitaxel, leucovorin calcium, fluorouracil, and irinotecan hydrochloride work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving Ramucirumab plus paclitaxel or FOLFIRI, may be helpful in treating advanced or refractory small bowel cancers and may help patients live longer.
Read the detailed description
PRIMARY OBJECTIVES:
- To evaluate whether progression-free survival (PFS) meets an efficacy threshold in patients with previously treated advanced small bowel adenocarcinoma who receive treatment with ramucirumab and paclitaxel or FOLFIRI.
II. If the stated threshold is met in both arms, to choose the better regimen with respect to progression free survival (PFS).
SECONDARY OBJECTIVES:
- To assess overall response rate (ORR) [complete and partial, confirmed and unconfirmed] in the subset of patients with measurable disease treated with ramucirumab and paclitaxel or FOLFIRI in this patient population.
II. To assess overall survival (OS) in patients treated with ramucirumab and paclitaxel or FOLFIRI in this patient population.
III. To evaluate safety and toxicity associated with combination ramucirumab and paclitaxel treatment or FOLFIRI therapy in this patient population.
TRANSLATIONAL OBJECTIVES:
- To explore the correlation of maximum decrease in CEA levels and time to maximum decrease in CEA levels with PFS, OS, and ORR.
II. To bank tissue and blood samples for other future correlative studies from patients enrolled on the study.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive ramucirumab intravenously (IV) over 30-60 minutes on days 1 and 15, and paclitaxel IV over 30 minutes on days 1, 8, and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
ARM II: Patients receive irinotecan IV over 90 minutes on days 1 and 15, leucovorin IV over 2 hours on days 1 and 15, and fluorouracil IV bolus on days 1 and 15. Patients also receive fluorouracil IV over 46-48 hours on days 1-3 and 15-17. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients completing study treatment are followed up every 8 weeks until disease progression. Once the disease has progressed, patients are followed up every 6 months for up to 3 years post registration.
- Conditions
- Metastatic Small Intestinal Adenocarcinoma, Stage III Small Intestinal Adenocarcinoma AJCC v8, Stage IIIA Small Intestinal Adenocarcinoma AJCC v8, Stage IIIB Small Intestinal Adenocarcinoma AJCC v8, Stage IV Small Intestinal Adenocarcinoma AJCC v8
- Being tested
- Fluorouracil, Irinotecan, Irinotecan Hydrochloride, Leucovorin, Leucovorin Calcium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FluorouracilDrug
Also called 5 Fluorouracil, 5 Fluorouracilum, 5 FU, 5-Fluoro-2,4(1H, 3H)-pyrimidinedione
Given IV bolus or IV
IrinotecanDrug
Given IV
Also called Campto, Camptosar, Camptothecin 11, Camptothecin-11
Given IV
LeucovorinDrug
Also called Folinic acid
Given IV
Also called Adinepar, Calcifolin, Calcium (6S)-Folinate, Calcium Folinate
Given IV
PaclitaxelDrug
Also called Anzatax, Asotax, Bristaxol, Praxel
Given IV
RamucirumabBiological
Also called Anti-VEGFR-2 Fully Human Monoclonal Antibody IMC-1121B, Cyramza, IMC-1121B, LY3009806
Given IV
| Study group | Role | What they receive |
|---|---|---|
| Arm I (ramucirumab, paclitaxel) | Experimental | Patients receive ramucirumab IV over 30-60 minutes on days 1 and 15, and paclitaxel IV over 30 minutes on days 1, 8, and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Receives: Drug: Paclitaxel; Biological: Ramucirumab |
| Arm II (irinotecan, leucovorin, fluorouracil) | Experimental | Patients receive irinotecan IV over 90 minutes on days 1 and 15, leucovorin IV over 2 hours on days 1 and 15, and fluorouracil IV bolus on days 1 and 15. Patients also receive fluorouracil IV over 46-48 hours on days 1-3 and 15-17. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Receives: Drug: Fluorouracil; Drug: Irinotecan; Drug: Irinotecan Hydrochloride; Drug: Leucovorin; Drug: Leucovorin Calcium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival (PFS)
PFS will be assessed in all eligible and evaluable (received at least one dose of protocol therapy) patients using the Kaplan-Meier method, with statistical differences in event rates between treatment arms assessed via stratified Cox regression model.
Measured: From date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause, assessed up to 3 years
Secondary outcomes (3)
Overall survival (OS)
Probabilities of OS will be estimated using the method of Kaplan-Meier, with statistical differences in event rates between treatment arms assessed via stratified Cox regression model.
Measured: From date of registration to date of death due to any cause, assessed up to 3 years
Overall response rate
Will be assessed by Response Evaluation Criteria in Solid Tumors 1.1. Will be compared across treatment arms via chi-square tests.
Measured: Up to 3 years after registration
Incidence of adverse events
Will be compared across treatment arms via chi-square tests.
Measured: Up to 3 years after registration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2019
- Study start1 Jun 2020
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Small Intestinal AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by SWOG Cancer Research NetworkThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 94 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SWOG Cancer Research Network
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Michael J Overman, Principal investigator, SWOG Cancer Research Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04205968
- Sponsor's protocol ID
- S1922
- Other IDs
- NCI-2019-04213, S1922, S1922, U10CA180888
- Status last verified
- Aug 2026
- First submitted
- 18 Dec 2019
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No