AzTrials
AzTrials

Locally Advanced Thymic CarcinomaPhase 2NCT03694002

Carboplatin and Paclitaxel With or Without Ramucirumab in Treating Patients With Locally Advanced, Recurrent, or Metastatic Thymic Cancer That Cannot Be Removed by Surgery

A Phase 2 study testing Carboplatin, Paclitaxel and Ramucirumab in people with Locally Advanced Thymic Carcinoma and Metastatic Thymic Carcinoma, run by SWOG Cancer Research Network at 254 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

This randomized phase II trial studies how well carboplatin and paclitaxel with or without ramucirumab work in treating patients with thymic cancer that has spread to other places in the body, has come back, or cannot be removed by surgery. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Carboplatin, Paclitaxel and Ramucirumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
21 participants
Where
254 sitesUnited States
Study dates
20 Mar 2019to 3 Mar 2025
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 thymic carcinoma; thymic carcinoma may be defined as "thymic epithelial malignancy, consistent with thymic carcinoma", or "World Health Organization (WHO) type C thymic epithelial tumor", or "thymic epithelial malignancy" with radiographic imaging consistent with thymic carcinoma
  • Patients must have unresectable thymic carcinoma, that is either locally advanced, recurrent, or metastatic
  • Patients must not be candidates for localized surgery
  • Patients must have measurable disease documented by computed tomography (CT) or magnetic resonance imaging (MRI) within 28 calendar days prior to randomization; the CT from a combined positron emission tomography (PET)/CT may be used only if it is of diagnostic quality; non-measurable disease must be assessed within 42 calendar days prior to randomization; all known sites of disease must be assessed and documented on the baseline tumor assessment form (Response Evaluation Criteria in Solid Tumors [RECIST] 1.1)
  • Patients must have a Zubrod performance status of 0 to 2
  • Patients must not have undergone major surgery within 28 calendar days prior to randomization, or minor surgery/subcutaneous venous access device placement within 7 calendar days prior to randomization; the patient must not have elective or planned major surgery to be performed during the course of the clinical trial
Show all 36Show fewer
  • Patients must not have had prior systemic anti-cancer therapy for locally advanced or metastatic unresectable thymic carcinoma
  • If patients have recurrent unresectable thymic carcinoma, patients may have had prior neoadjuvant or adjuvant chemotherapy if treatment concluded >= 6 months prior to randomization
  • Patients must have a CT or MRI scan of the brain to evaluate for central nervous system (CNS) disease within 42 calendar days prior to registration; patient must not have brain metastases unless: (1) metastases have been treated and have remained controlled for at least two weeks following treatment, AND (2) patient has no residual neurological dysfunction off corticosteroids for at least 1 day
  • Patients must not be candidates for radiation therapy with curative intent; prior palliative radiation therapy is allowed as long as a period of 7 days has passed since the last dose was received and the patient has recovered from any associated toxicity at the time of randomization
  • Absolute neutrophil count (ANC) >= 1500/mcL documented within 28 calendar days prior to randomization
  • Hemoglobin >= 9 g/dL (5.58 mmol/L) documented within 28 calendar days prior to randomization
  • Platelets >= 100,000/mcL documented within 28 calendar days prior to randomization
  • International normalized ratio (INR) =< 1.5 documented within 28 calendar days prior to randomization
  • Partial thromboplastin time (PTT) =< 5 seconds above the institutional upper limit of normal (IULN) (unless receiving anticoagulation therapy) documented within 28 calendar days prior to randomization
  • Patients receiving warfarin must be switched to low molecular weight heparin and have achieved stable coagulation profile 14 days prior to randomization
  • Patients must not have experienced any grade 3 or above gastrointestinal (GI) bleeding within 84 calendar days prior to randomization
  • 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 84 calendar days prior to randomization
  • Total bilirubin =< 1.5 x the institutional upper limit normal (IULN) documented within 28 calendar days prior to randomization
  • Aspartate aminotransferase (aspartate transaminase [AST]) and alanine aminotransferase (alanine transaminase [ALT]) =< 3.0 x IULN; for patients with liver metastases, total bilirubin and AST or ALT must be =< 5.0 x IULN documented within 28 calendar days prior to randomization
  • Patients must not have any of following:
  • Cirrhosis at a level of Child-Pugh B (or worse)
  • 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
  • Serum creatinine =< 1.5 x IULN, or creatinine clearance (measured via 24-hour urine collection) >= 40 mL/minute (that is, if serum creatinine is > 1.5 x ULN, a 24-hour urine collection to calculate creatinine clearance must be performed) documented within 28 calendar days prior to randomization
  • Patient urinary protein must be =< 1+ on dipstick or routine urinalysis (UA); if urine dipstick or routine analysis is >= 2+, a 24-hour urine collection for protein must demonstrate < 1000 mg of protein in 24 hours); these tests must be documented within 28 calendar days prior to randomization
  • Patients must not have experienced any arterial thromboembolic events, including but not limited to myocardial infarction, transient ischemic attack, cerebrovascular accident, or unstable angina, within 6 months prior to randomization
  • Patients must not have a history of uncontrolled or poorly-controlled hypertension (defined as > 160 mmHg systolic or > 100 mmHg diastolic for > 4 weeks) despite standard medical management
  • Patients must not be pregnant or nursing; women/men of reproductive potential must have agreed to use an effective contraceptive method (hormonal or barrier method of birth control; abstinence) prior to randomization, during the study participation and for 4 months after the last dose of protocol treatment; 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 experienced hemoptysis (defined as bright red blood or >= 1/2 teaspoon) within 2 months prior to randomization or with radiographic evidence of intratumor cavitation or has radiologically documented evidence of major blood vessel invasion or encasement by cancer
  • Patients must not have a prior history of gastrointestinal perforation/fistula (within 6 months of randomization) or risk factors for perforation
  • Patients must not have a serious or nonhealing wound, ulcer, or bone fracture within 28 calendar days prior to randomization
  • Patients must not be receiving chronic antiplatelet therapy, including aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs, including ibuprofen, naproxen, and others), dipyridamole or clopidogrel, or similar agents within 7 days prior to randomization; once-daily aspirin use (maximum dose 325 mg/day) is permitted
  • Patients must be offered the opportunity to participate in banking of specimens for future research
  • 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
  • As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system

Who cannot join

None listed.

Trial locations and contacts

254 sites in 1 country.

254 sites in 1 country

United States254 sites

  • Providence Regional Cancer System-Aberdeen

    Aberdeen, Washington, 98520

  • Community Hospital of Anaconda

    Anaconda, Montana, 59711

  • Anchorage Associates in Radiation Medicine

    Anchorage, Alaska, 98508

  • Anchorage Radiation Therapy Center

    Anchorage, Alaska, 99504

  • Alaska Breast Care and Surgery LLC

    Anchorage, Alaska, 99508

  • Alaska Oncology and Hematology LLC

    Anchorage, Alaska, 99508

  • Alaska Women's Cancer Care

    Anchorage, Alaska, 99508

  • Anchorage Oncology Centre

    Anchorage, Alaska, 99508

  • Katmai Oncology Group

    Anchorage, Alaska, 99508

  • Providence Alaska Medical Center

    Anchorage, Alaska, 99508

  • Mission Hope Medical Oncology - Arroyo Grande

    Arroyo Grande, California, 93420

  • PCR Oncology

    Arroyo Grande, California, 93420

  • Saint Alphonsus Medical Center-Baker City

    Baker City, Oregon, 97814

  • Greater Baltimore Medical Center

    Baltimore, Maryland, 21204

  • Flaget Memorial Hospital

    Bardstown, Kentucky, 40004

  • Overlake Medical Center

    Bellevue, Washington, 98004

  • PeaceHealth Saint Joseph Medical Center

    Bellingham, Washington, 98225

  • Saint Charles Health System

    Bend, Oregon, 97701

  • Billings Clinic Cancer Center

    Billings, Montana, 59101

  • Saint Alphonsus Cancer Care Center-Boise

    Boise, Idaho, 83706

  • Saint Luke's Mountain States Tumor Institute

    Boise, Idaho, 83712

  • Bozeman Deaconess Hospital

    Bozeman, Montana, 59715

  • Harrison HealthPartners Hematology and Oncology-Bremerton

    Bremerton, Washington, 98310

  • Harrison Medical Center

    Bremerton, Washington, 98310

  • Henry Ford Cancer Institute-Downriver

    Brownstown, Michigan, 48183

  • Saint Joseph Regional Cancer Center

    Bryan, Texas, 77802

  • Providence Saint Joseph Medical Center/Disney Family Cancer Center

    Burbank, California, 91505

  • Highline Medical Center-Main Campus

    Burien, Washington, 98166

  • Fairview Ridges Hospital

    Burnsville, Minnesota, 55337

  • Minnesota Oncology - Burnsville

    Burnsville, Minnesota, 55337

  • Saint Alphonsus Cancer Care Center-Caldwell

    Caldwell, Idaho, 83605

  • Cambridge Medical Center

    Cambridge, Minnesota, 55008

  • Carson Tahoe Regional Medical Center

    Carson City, Nevada, 89703

  • Providence Regional Cancer System-Centralia

    Centralia, Washington, 98531

  • Memorial Hospital

    Chattanooga, Tennessee, 37404

  • Northwestern University

    Chicago, Illinois, 60611

  • Marshfield Clinic-Chippewa Center

    Chippewa Falls, Wisconsin, 54729

  • Good Samaritan Hospital - Cincinnati

    Cincinnati, Ohio, 45220

  • Bethesda North Hospital

    Cincinnati, Ohio, 45242

  • TriHealth Cancer Institute-Westside

    Cincinnati, Ohio, 45247

  • TriHealth Cancer Institute-Anderson

    Cincinnati, Ohio, 45255

  • Clackamas Radiation Oncology Center

    Clackamas, Oregon, 97015

  • Providence Cancer Institute Clackamas Clinic

    Clackamas, Oregon, 97015

  • Henry Ford Macomb Hospital-Clinton Township

    Clinton Township, Michigan, 48038

  • Medical Oncology and Hematology Associates-West Des Moines

    Clive, Iowa, 50325

  • Mercy Cancer Center-West Lakes

    Clive, Iowa, 50325

  • Billings Clinic-Cody

    Cody, Wyoming, 82414

  • Kootenai Medical Center

    Coeur d'Alene, Idaho, 83814

  • Penrose-Saint Francis Healthcare

    Colorado Springs, Colorado, 80907

  • Rocky Mountain Cancer Centers-Penrose

    Colorado Springs, Colorado, 80907

  • Mercy Hospital

    Coon Rapids, Minnesota, 55433

  • Bay Area Hospital

    Coos Bay, Oregon, 97420

  • Commonwealth Cancer Center-Corbin

    Corbin, Kentucky, 40701

  • Alegent Health Mercy Hospital

    Council Bluffs, Iowa, 51503

  • Greater Regional Medical Center

    Creston, Iowa, 50801

  • Henry Ford Medical Center-Fairlane

    Dearborn, Michigan, 48126

  • Porter Adventist Hospital

    Denver, Colorado, 80210

  • Medical Oncology and Hematology Associates-Laurel

    Des Moines, Iowa, 50314

  • Mercy Medical Center - Des Moines

    Des Moines, Iowa, 50314

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • City of Hope Comprehensive Cancer Center

    Duarte, California, 91010

  • Mercy Medical Center

    Durango, Colorado, 81301

  • Southwest Oncology PC

    Durango, Colorado, 81301

  • Prisma Health Cancer Institute - Easley

    Easley, South Carolina, 29640

  • Marshfield Medical Center-EC Cancer Center

    Eau Claire, Wisconsin, 54701

  • Fairview Southdale Hospital

    Edina, Minnesota, 55435

  • Swedish Cancer Institute-Edmonds

    Edmonds, Washington, 98026

  • Walter Knox Memorial Hospital

    Emmett, Idaho, 83617

  • Saint Elizabeth Hospital

    Enumclaw, Washington, 98022

  • Providence Regional Cancer Partnership

    Everett, Washington, 98201

  • Saint Francis Hospital

    Federal Way, Washington, 98003

  • Unity Hospital

    Fridley, Minnesota, 55432

  • Saint Luke's Cancer Institute - Fruitland

    Fruitland, Idaho, 83619

  • Mountain Blue Cancer Care Center

    Golden, Colorado, 80401

  • CHI Health Saint Francis

    Grand Island, Nebraska, 68803

  • Benefis Healthcare- Sletten Cancer Institute

    Great Falls, Montana, 59405

  • Great Falls Clinic

    Great Falls, Montana, 59405

  • Prisma Health Cancer Institute - Butternut

    Greenville, South Carolina, 29605

  • Prisma Health Cancer Institute - Faris

    Greenville, South Carolina, 29605

  • Prisma Health Cancer Institute - Eastside

    Greenville, South Carolina, 29615

  • Prisma Health Cancer Institute - Greer

    Greer, South Carolina, 29650

  • UPMC Pinnacle Cancer Center/Community Osteopathic Campus

    Harrisburg, Pennsylvania, 17109

  • Saint Peter's Community Hospital

    Helena, Montana, 59601

  • Cancer and Blood Specialists-Henderson

    Henderson, Nevada, 89052

  • Comprehensive Cancer Centers of Nevada - Henderson

    Henderson, Nevada, 89052

  • Comprehensive Cancer Centers of Nevada-Horizon Ridge

    Henderson, Nevada, 89052

  • Las Vegas Cancer Center-Henderson

    Henderson, Nevada, 89052

  • OptumCare Cancer Care at Seven Hills

    Henderson, Nevada, 89052

  • 21st Century Oncology-Henderson

    Henderson, Nevada, 89074

  • Comprehensive Cancer Centers of Nevada-Southeast Henderson

    Henderson, Nevada, 89074

  • Las Vegas Urology - Green Valley

    Henderson, Nevada, 89074

  • Las Vegas Urology - Pebble

    Henderson, Nevada, 89074

  • Urology Specialists of Nevada - Green Valley

    Henderson, Nevada, 89074

  • Pulmonary Medicine Center of Chattanooga-Hixson

    Hixson, Tennessee, 37343

  • CHI Saint Vincent Cancer Center Hot Springs

    Hot Springs, Arkansas, 71913

  • M D Anderson Cancer Center

    Houston, Texas, 77030

  • Swedish Cancer Institute-Issaquah

    Issaquah, Washington, 98029

  • Allegiance Health

    Jackson, Michigan, 49201

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216

  • Kalispell Regional Medical Center

    Kalispell, Montana, 59901

  • Heartland Hematology and Oncology

    Kearney, Nebraska, 68845

  • CHI Health Good Samaritan

    Kearney, Nebraska, 68847

  • Kadlec Clinic Hematology and Oncology

    Kennewick, Washington, 99336

  • Kingman Regional Medical Center

    Kingman, Arizona, 86401

  • Providence Regional Cancer System-Lacey

    Lacey, Washington, 98503

  • Marshfield Clinic - Ladysmith Center

    Ladysmith, Wisconsin, 54848

  • Northwestern Medicine Lake Forest Hospital

    Lake Forest, Illinois, 60045

  • Rocky Mountain Cancer Centers-Lakewood

    Lakewood, Colorado, 80228

  • Saint Anthony Hospital

    Lakewood, Colorado, 80228

  • Saint Clare Hospital

    Lakewood, Washington, 98499

  • City of Hope Antelope Valley

    Lancaster, California, 93534

  • Las Vegas Urology - Pecos

    Las Vegas, Nevada, 89074

  • Desert West Surgery

    Las Vegas, Nevada, 89102

  • OptumCare Cancer Care at Oakey

    Las Vegas, Nevada, 89102

  • University Medical Center of Southern Nevada

    Las Vegas, Nevada, 89102

  • Hope Cancer Care of Nevada

    Las Vegas, Nevada, 89103

  • Cancer and Blood Specialists-Shadow

    Las Vegas, Nevada, 89106

  • Radiation Oncology Centers of Nevada Central

    Las Vegas, Nevada, 89106

  • Urology Specialists of Nevada - Central

    Las Vegas, Nevada, 89106

  • 21st Century Oncology

    Las Vegas, Nevada, 89109

  • HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway

    Las Vegas, Nevada, 89109

  • Sunrise Hospital and Medical Center

    Las Vegas, Nevada, 89109

  • HealthCare Partners Medical Group Oncology/Hematology-San Martin

    Las Vegas, Nevada, 89113

  • Las Vegas Prostate Cancer Center

    Las Vegas, Nevada, 89113

  • Las Vegas Urology - Sunset

    Las Vegas, Nevada, 89113

  • Radiation Oncology Centers of Nevada Southeast

    Las Vegas, Nevada, 89119

  • 21st Century Oncology-Vegas Tenaya

    Las Vegas, Nevada, 89128

  • Ann M Wierman MD LTD

    Las Vegas, Nevada, 89128

  • Cancer and Blood Specialists-Tenaya

    Las Vegas, Nevada, 89128

  • Comprehensive Cancer Centers of Nevada - Northwest

    Las Vegas, Nevada, 89128

  • HealthCare Partners Medical Group Oncology/Hematology-Tenaya

    Las Vegas, Nevada, 89128

  • Las Vegas Urology - Cathedral Rock

    Las Vegas, Nevada, 89128

  • Las Vegas Urology - Smoke Ranch

    Las Vegas, Nevada, 89128

  • OptumCare Cancer Care at MountainView

    Las Vegas, Nevada, 89128

  • Urology Specialists of Nevada - Northwest

    Las Vegas, Nevada, 89128

  • Alliance for Childhood Diseases/Cure 4 the Kids Foundation

    Las Vegas, Nevada, 89135

  • Comprehensive Cancer Centers of Nevada - Town Center

    Las Vegas, Nevada, 89144

  • Comprehensive Cancer Centers of Nevada-Summerlin

    Las Vegas, Nevada, 89144

  • Summerlin Hospital Medical Center

    Las Vegas, Nevada, 89144

  • Las Vegas Cancer Center-Medical Center

    Las Vegas, Nevada, 89148-2405

  • 21st Century Oncology-Fort Apache

    Las Vegas, Nevada, 89148

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada, 89148

  • OptumCare Cancer Care at Fort Apache

    Las Vegas, Nevada, 89148

  • Urology Specialists of Nevada - Southwest

    Las Vegas, Nevada, 89148

  • HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills

    Las Vegas, Nevada, 89149

  • Comprehensive Cancer Centers of Nevada - Central Valley

    Las Vegas, Nevada, 89169

  • University Cancer Center

    Las Vegas, Nevada, 89169

  • Saint Joseph Radiation Oncology Resource Center

    Lexington, Kentucky, 40504

  • Saint Joseph Hospital East

    Lexington, Kentucky, 40509

  • Saint Elizabeth Regional Medical Center

    Lincoln, Nebraska, 68510

  • Littleton Adventist Hospital

    Littleton, Colorado, 80122

  • Saint Joseph London

    London, Kentucky, 40741

  • Longmont United Hospital

    Longmont, Colorado, 80501

  • Rocky Mountain Cancer Centers-Longmont

    Longmont, Colorado, 80501

  • PeaceHealth Saint John Medical Center

    Longview, Washington, 98632

  • Jewish Hospital

    Louisville, Kentucky, 40202

  • Saints Mary and Elizabeth Hospital

    Louisville, Kentucky, 40215

  • Jewish Hospital Medical Center Northeast

    Louisville, Kentucky, 40245

  • Fairview Clinics and Surgery Center Maple Grove

    Maple Grove, Minnesota, 55369

  • Minnesota Oncology Hematology PA-Maplewood

    Maplewood, Minnesota, 55109

  • Saint John's Hospital - Healtheast

    Maplewood, Minnesota, 55109

  • Marshfield Medical Center-Marshfield

    Marshfield, Wisconsin, 54449

  • Fremont - Rideout Cancer Center

    Marysville, California, 95901

  • Idaho Urologic Institute-Meridian

    Meridian, Idaho, 83642

  • Saint Luke's Cancer Institute - Meridian

    Meridian, Idaho, 83642

  • Abbott-Northwestern Hospital

    Minneapolis, Minnesota, 55407

  • Hennepin County Medical Center

    Minneapolis, Minnesota, 55415

  • Health Partners Inc

    Minneapolis, Minnesota, 55454

  • Marshfield Clinic-Minocqua Center

    Minocqua, Wisconsin, 54548

  • City of Hope Mission Hills

    Mission Hills, California, 91345

  • Saint Patrick Hospital - Community Hospital

    Missoula, Montana, 59802

  • Community Medical Hospital

    Missoula, Montana, 59804

  • Monticello Cancer Center

    Monticello, Minnesota, 55362

  • Saint Alphonsus Medical Center-Nampa

    Nampa, Idaho, 83686

  • Saint Luke's Cancer Institute - Nampa

    Nampa, Idaho, 83686

  • Cancer Center of Western Wisconsin

    New Richmond, Wisconsin, 54017

  • New Ulm Medical Center

    New Ulm, Minnesota, 56073

  • NYP/Weill Cornell Medical Center

    New York, New York, 10065

  • Providence Newberg Medical Center

    Newberg, Oregon, 97132

  • Henry Ford Medical Center-Columbus

    Novi, Michigan, 48377

  • Alegent Health Immanuel Medical Center

    Omaha, Nebraska, 68122

  • Hematology and Oncology Consultants PC

    Omaha, Nebraska, 68122

  • Alegent Health Bergan Mercy Medical Center

    Omaha, Nebraska, 68124

  • Alegent Health Lakeside Hospital

    Omaha, Nebraska, 68130

  • Creighton University Medical Center

    Omaha, Nebraska, 68131

  • Saint Alphonsus Medical Center-Ontario

    Ontario, Oregon, 97914

  • Memorial GYN Plus

    Ooltewah, Tennessee, 37363

  • Hope Cancer Care of Nevada-Pahrump

    Pahrump, Nevada, 89048

  • Midlands Community Hospital

    Papillion, Nebraska, 68046

  • Parker Adventist Hospital

    Parker, Colorado, 80138

  • Rocky Mountain Cancer Centers-Parker

    Parker, Colorado, 80138

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

  • University of Pittsburgh Cancer Institute (UPCI)

    Pittsburgh, Pennsylvania, 15232

  • Providence Portland Medical Center

    Portland, Oregon, 97213

  • Providence Saint Vincent Medical Center

    Portland, Oregon, 97225

  • Kootenai Cancer Center

    Post Falls, Idaho, 83854

  • Harrison HealthPartners Hematology and Oncology-Poulsbo

    Poulsbo, Washington, 98370

  • Fairview Northland Medical Center

    Princeton, Minnesota, 55371

  • Saint Mary Corwin Medical Center

    Pueblo, Colorado, 81004

  • Rocky Mountain Cancer Centers - Pueblo

    Pueblo, Colorado, 81008

  • Saint Charles Health System-Redmond

    Redmond, Oregon, 97756

  • Renown Regional Medical Center

    Reno, Nevada, 89502

  • Saint Mary's Regional Medical Center

    Reno, Nevada, 89503

  • Radiation Oncology Associates

    Reno, Nevada, 89509

  • Valley Medical Center

    Renton, Washington, 98055

  • Marshfield Medical Center-Rice Lake

    Rice Lake, Wisconsin, 54868

  • North Memorial Medical Health Center

    Robbinsdale, Minnesota, 55422

  • University of California Davis Comprehensive Cancer Center

    Sacramento, California, 95817

  • Park Nicollet Clinic - Saint Louis Park

    Saint Louis Park, Minnesota, 55416

  • Regions Hospital

    Saint Paul, Minnesota, 55101

  • United Hospital

    Saint Paul, Minnesota, 55102

  • Huntsman Cancer Institute/University of Utah

    Salt Lake City, Utah, 84112

  • Kootenai Cancer Clinic

    Sandpoint, Idaho, 83864

  • Mission Hope Medical Oncology - Santa Maria

    Santa Maria, California, 93444

  • Pacific Gynecology Specialists

    Seattle, Washington, 98104

  • Swedish Medical Center-Ballard Campus

    Seattle, Washington, 98107

  • Fred Hutchinson Cancer Research Center

    Seattle, Washington, 98109

  • Seattle Cancer Care Alliance

    Seattle, Washington, 98109

  • Kaiser Permanente Washington

    Seattle, Washington, 98112

  • Swedish Medical Center-First Hill

    Seattle, Washington, 98122-4307

  • Swedish Medical Center-Cherry Hill

    Seattle, Washington, 98122-5711

  • University of Washington Medical Center

    Seattle, Washington, 98195

  • PeaceHealth United General Medical Center

    Sedro-Woolley, Washington, 98284

  • Prisma Health Cancer Institute - Seneca

    Seneca, South Carolina, 29672

  • Saint Francis Regional Medical Center

    Shakopee, Minnesota, 55379

  • Henry Ford Macomb Health Center - Shelby Township

    Shelby, Michigan, 48315

  • Providence Regional Cancer System-Shelton

    Shelton, Washington, 98584

  • Jewish Hospital Medical Center South

    Shepherdsville, Kentucky, 40165

  • Welch Cancer Center

    Sheridan, Wyoming, 82801

  • City of Hope South Pasadena

    South Pasadena, California, 91030

  • Prisma Health Cancer Institute - Spartanburg

    Spartanburg, South Carolina, 29307

  • Marshfield Clinic Stevens Point Center

    Stevens Point, Wisconsin, 54482

  • Lakeview Hospital

    Stillwater, Minnesota, 55082

  • State University of New York Upstate Medical University

    Syracuse, New York, 13210

  • Franciscan Research Center-Northwest Medical Plaza

    Tacoma, Washington, 98405

  • Northwest Medical Specialties PLLC

    Tacoma, Washington, 98405

  • Moffitt Cancer Center-International Plaza

    Tampa, Florida, 33607

  • Moffitt Cancer Center - McKinley Campus

    Tampa, Florida, 33612

  • Moffitt Cancer Center

    Tampa, Florida, 33612

  • Rocky Mountain Cancer Centers-Thornton

    Thornton, Colorado, 80260

  • Saint Luke's Cancer Institute - Twin Falls

    Twin Falls, Idaho, 83301

  • PeaceHealth Southwest Medical Center

    Vancouver, Washington, 98664

  • Ridgeview Medical Center

    Waconia, Minnesota, 55387

  • Providence Saint Mary Regional Cancer Center

    Walla Walla, Washington, 99362

  • Marshfield Clinic-Wausau Center

    Wausau, Wisconsin, 54401

  • Henry Ford West Bloomfield Hospital

    West Bloomfield, Michigan, 48322

  • City of Hope West Covina

    West Covina, California, 91790

  • Mercy Medical Center-West Lakes

    West Des Moines, Iowa, 50266

  • Marshfield Clinic - Weston Center

    Weston, Wisconsin, 54476

  • Rice Memorial Hospital

    Willmar, Minnesota, 56201

  • Marshfield Clinic - Wisconsin Rapids Center

    Wisconsin Rapids, Wisconsin, 54494

  • Minnesota Oncology Hematology PA-Woodbury

    Woodbury, Minnesota, 55125

  • Fairview Lakes Medical Center

    Wyoming, Minnesota, 55092

  • Providence Regional Cancer System-Yelm

    Yelm, Washington, 98597

Other trials in United States

About this study

Official title: A Randomized Phase II Trial of Carboplatin-Paclitaxel With or Without Ramucirumab in Patients With Unresectable Locally Advanced, Recurrent, or Metastatic Thymic Carcinoma

This randomized phase II trial studies how well carboplatin and paclitaxel with or without ramucirumab work in treating patients with thymic cancer that has spread to other places in the body, has come back, or cannot be removed by surgery. Drugs used in chemotherapy, such as carboplatin and paclitaxel, 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. Monoclonal antibodies, such as ramucirumab, may interfere with the ability of tumor cells to grow and spread. It is not yet known if giving carboplatin and paclitaxel with or without ramucirumab will work better in treating patients with thymic cancer.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To compare progression-free survival between patients with incurable unresectable locally advanced, or recurrent, or metastatic thymic carcinoma randomized to carboplatin-paclitaxel with or without ramucirumab.

SECONDARY OBJECTIVES:

  1. To evaluate the frequency and severity of toxicity of carboplatin-paclitaxel with or without ramucirumab in this patient population.

II. To compare the response rate (complete response, partial response, confirmed and unconfirmed) between treatment arms.

III. To compare disease control rate (complete response, partial response, confirmed or unconfirmed, stable disease) between treatment arms.

IV. To compare overall survival between treatment arms.

ADDITIONAL OBJECTIVE:

  1. To bank specimens for future research.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM A: Patients receive ramucirumab intravenously (IV) over 60 minutes, carboplatin IV, and paclitaxel IV on day 1. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients who have not progressed may continue to receive ramucirumab for up to 1 year.

ARM B: Patients receive carboplatin IV and paclitaxel IV on day 1. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for 1 year, and then every 6 months for 1 year.

Being tested
Carboplatin, Paclitaxel, Ramucirumab
Medical subject headings
Thymoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CarboplatinDrug

    Also called Blastocarb, Carboplat, Carboplatin Hexal, Carboplatino

    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 groups in NCT03694002
Study groupRoleWhat they receive
Arm A (ramucirumab, carboplatin, paclitaxel)ExperimentalPatients receive ramucirumab IV over 60 minutes, carboplatin IV, and paclitaxel IV on day 1. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients who have not progressed may continue to receive ramucirumab for up to 1 year.
Receives: Drug: Carboplatin; Drug: Paclitaxel; Biological: Ramucirumab
Arm B (carboplatin, paclitaxel)Active comparatorPatients receive carboplatin IV and paclitaxel IV on day 1. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
Receives: Drug: Carboplatin; Drug: Paclitaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free Survival

    Compare progression-free survival between patients with incurable unresectable locally advanced, or recurrent, or metastatic thymic carcinoma randomized to carboplatin-paclitaxel with or without ramucirumab. Progression-free survival is defined as: From date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause.

    Progression is defined as: 20% increase in the sum of appropriate diameters of target measurable lesions over smallest sum observed, as well as an absolute increase of at least 0.5 cm. Unequivocal progression of non-measurable disease in the opinion of the treating physician (an explanation must be provided). Appearance of any new lesion/site. Death due to disease without prior documentation of progression and without symptomatic deterioration

    Measured: up to 2 years after registration

Secondary outcomes (4)

  1. Frequency and Severity of Adverse Events

    Only adverse events that are possibly, probably or definitely related to study drug are reported.

    Measured: Up to 2 years post randomization

  2. Response Rate

    To compare the response rate (complete response, partial response, confirmed and unconfirmed) between treatment arms in the subset of this patient population with measurable disease.

    Complete response - Complete disappearance of all target and non-target lesions (with the exception of lymph nodes mentioned below). No new lesions. No disease related symptoms. Any lymph nodes (whether target or non-target) must have reduction in short axis to < 1.0 cm.

    Partial response - Applies only to patients with at least 1 measurable lesion. Greater than or equal to 30% decrease under baseline of the sum of appropriate diameters of all targets measurable lesions. No unequivocal progression of non-measurable disease. No new lesions.

    Measured: Up to 2 years after registration

  3. Disease Control Rate

    To compare disease control rate (complete response, partial response, confirmed or unconfirmed, stable disease) between treatment arms in the subset of this patient population with measurable disease.

    Measured: Up to 2 years after registration

  4. Overall Survival

    To compare overall survival between treatment arms. Overall survival is defined as time from date of registration to date of death due to any cause. Because of low accrual, and too few participant deaths, we do not plan to analyze or report with outcome.

    Measured: Up to 2 years after registration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Oct 2018
  2. Study start20 Mar 2019
  3. Primary completion1 Dec 2024
  4. Study completion3 Mar 2025

Resources

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
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03694002
Sponsor's protocol ID
S1701
Other IDs
NCI-2017-02254, S1701, S1701, S1701, U10CA180888
Status last verified
Oct 2025
First submitted
1 Oct 2018
Last updated
30 Oct 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

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