AzTrials
AzTrials

Recurrent Colon CancerPhase 2NCT00826540

Sorafenib and Bevacizumab in Treating Patients With Metastatic Colorectal Cancer

A Phase 2 study testing sorafenib tosylate and bevacizumab in people with Recurrent Colon Cancer and Recurrent Rectal Cancer, run by Alliance for Clinical Trials in Oncology at 211 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 phase II trial is studying how well giving sorafenib together with bevacizumab works in treating patients with metastatic colorectal cancer. Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
sorafenib tosylate and bevacizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
83 participants
Where
211 sitesUnited States
Study dates
Sep 2009to Feb 2014
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Diagnosis of stage IV colorectal cancer (histologic proof is not required)
  • Measurable disease
  • Spiral CT scan required for both pre- and post-treatment tumor assessments of lesions measuring 1-2 cm
  • Progressive disease during or within 6 months of most recent prior chemotherapy regimen (bevacizumab, fluoropyrimidine, oxaliplatin, or irinotecan-based treatment) OR considered ineligible for standard therapy
  • Documentation of submission of tumor material for Kirsten Rat Sarcoma (KRAS) testing available
  • Prior anti-epidermal growth factor receptor (EGFR) antibody therapy (e.g., cetuximab or panitumumab) required for patients with wild-type KRAS tumor
Show all 64Show fewer
  • No known brain metastasis
  • Patients with neurological symptoms must undergo a CT scan or MRI of the brain to exclude brain metastasis
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1
  • Life expectancy ≥ 6 months
  • Hemoglobin ≥ 9.0 g/dL
  • Absolute neutrophil count (ANC) ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • White blood cell count (WBC) ≥ 3,400/mm³
  • International normalized ratio (INR) < 1.5 (≤ 3.0 if on anti-coagulation therapy [e.g., warfarin or heparin])
  • Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • Aspartate aminotransferase (AST) ≤ 2.5 times ULN (≤ 5 times ULN if there is liver involvement)
  • Alkaline phosphatase ≤ 3 times ULN
  • Creatinine ≤ 1.5 times ULN
  • Urine protein:creatinine ratio < 1 OR urine dipstick < 2+ OR urine protein < 1,000 mg by 24-hour urine collection
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for ≥ 6 months after completion of study treatment (≥ 2 weeks after completion of treatment with sorafenib tosylate alone)
  • Willing to provide mandatory blood samples for translational research studies
  • Able to swallow whole pills
  • No inadequately controlled hypertension (i.e., systolic BP > 150 mm Hg or diastolic BP > 100 mm Hg on anti-hypertensive medications)
  • No prior hypertensive crisis or hypertensive encephalopathy
  • No myocardial infarction or unstable angina within the past 6 months
  • No congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias
  • No thrombolic or embolic events (e.g., cerebrovascular accident, including transient ischemic attacks) within the past 6 months
  • No hemorrhage or bleeding event > grade 3 within the past 4 weeks
  • No evidence or history of bleeding diathesis or coagulopathy (in the absence of therapeutic anticoagulation)
  • No greater than normal risk of bleeding
  • No active or recent hemoptysis (≥ ½ teaspoon of bright red blood per episode) within the past 30 days
  • No concurrent uncontrolled illness including, but not limited to, any of the following:
  • Ongoing or active infection
  • Symptomatic congestive heart failure
  • Unstable angina pectoris
  • Cardiac arrhythmia requiring anti-arrhythmic drugs
  • Psychiatric illness or social situations that would limit compliance with study requirements
  • No known HIV infection or chronic hepatitis B or C infection
  • No serious, non-healing wound, active ulcer, or untreated bone fracture
  • Patients with fractures secondary to metastatic disease are eligible after appropriate radiotherapy
  • No significant traumatic injury within the past 4 weeks
  • No known or suspected allergy or hypersensitivity to any component of bevacizumab, sorafenib tosylate, or their excipients or to any other agent given in the course of this study
  • No malabsorption problem
  • None of the following within the past 6 months:
  • Significant vascular disease (e.g., aortic aneurysm or aortic dissection)
  • Peripheral arterial thrombosis
  • Symptomatic peripheral vascular disease
  • Abdominal fistula
  • Gastrointestinal perforation
  • Intra-abdominal abscess
  • No other active malignancy within the past 3 years except non melanoma skin cancer or carcinoma in situ of the cervix
  • Prior malignancy allowed provided patient is not receiving other specific treatment for that malignancy (other than hormonal therapy)
  • No other concurrent investigational agent for this cancer
  • Prior radiotherapy allowed
  • No prior sorafenib tosylate
  • No prior discontinuation of bevacizumab due to adverse events
  • More than 4 weeks since prior and no concurrent participation in any other experimental drug study
  • More than 4 weeks since prior St. John's wort or rifampin
  • More than 4 weeks since prior and no concurrent major surgical procedure or open biopsy
  • More than 7 days since prior core biopsy or minor surgical procedure, including placement of a vascular access device
  • No concurrent anticoagulant, except low-dose warfarin or heparin for deep venous thrombosis prophylaxis

Who cannot join

None listed.

Trial locations and contacts

211 sites in 1 country.

211 sites in 1 country

United States211 sites

  • Bixby Medical Center

    Adrian, Michigan, 49221

  • Hickman Cancer Center

    Adrian, Michigan, 49221

  • Saint Joseph Mercy Hospital

    Ann Arbor, Michigan, 48106-0995

  • Michigan Cancer Research Consortium Community Clinical Oncology Program

    Ann Arbor, Michigan, 48106

  • Hospital District Sixth of Harper County

    Anthony, Kansas, 67003

  • The Medical Center of Aurora

    Aurora, Colorado, 80012

  • Saint Francis Hospital and Health Centers

    Beech Grove, Indiana, 46107

  • Sanford Clinic North-Bemidgi

    Bemidji, Minnesota, 56601

  • Constantinou, Costas L MD (UIA Investigator)

    Bettendorf, Iowa, 52722

  • Montana Cancer Consortium CCOP

    Billings, Montana, 59101

  • Northern Rockies Radiation Oncology Center

    Billings, Montana, 59101

  • Saint Vincent Healthcare

    Billings, Montana, 59101

  • Hematology-Oncology Centers of the Northern Rockies PC

    Billings, Montana, 59102

  • Billings Clinic

    Billings, Montana, 59107-7000

  • Bismarck Cancer Center

    Bismarck, North Dakota, 58501

  • Mid Dakota Clinic

    Bismarck, North Dakota, 58501

  • Saint Alexius Medical Center

    Bismarck, North Dakota, 58501

  • Sanford Bismarck Medical Center

    Bismarck, North Dakota, 58501

  • Saint Joseph Medical Center

    Bloomington, Illinois, 61701

  • Boulder Community Hospital

    Boulder, Colorado, 80301

  • Toledo Clinic Cancer Centers-Bowling Green

    Bowling Green, Ohio, 43402

  • Bozeman Deaconess Cancer Center

    Bozeman, Montana, 59715

  • Fairview Ridges Hospital

    Burnsville, Minnesota, 55337

  • Saint James Community Hospital and Cancer Treatment Center

    Butte, Montana, 59701

  • Graham Hospital Association

    Canton, Illinois, 61520

  • Memorial Hospital

    Carthage, Illinois, 62321

  • Cedar Rapids Oncology Association

    Cedar Rapids, Iowa, 52403

  • Mercy Hospital

    Cedar Rapids, Iowa, 52403

  • Oncology Associates at Mercy Medical Center

    Cedar Rapids, Iowa, 52403

  • Cancer Center of Kansas - Chanute

    Chanute, Kansas, 66720

  • Medical Oncology and Hematology Associates-West Des Moines

    Clive, Iowa, 50325

  • North Coast Cancer Care-Clyde

    Clyde, Ohio, 43410

  • Penrose-Saint Francis Healthcare

    Colorado Springs, Colorado, 80907

  • Mercy Hospital

    Coon Rapids, Minnesota, 55433

  • Geisinger Medical Center

    Danville, Pennsylvania, 17822-2001

  • Grandview Hospital

    Dayton, Ohio, 45405

  • Good Samaritan Hospital - Dayton

    Dayton, Ohio, 45406

  • Miami Valley Hospital

    Dayton, Ohio, 45409

  • Samaritan North Health Center

    Dayton, Ohio, 45415

  • Dayton CCOP

    Dayton, Ohio, 45420

  • Oakwood Hospital

    Dearborn, Michigan, 48124

  • Saint Anthony Central Hospital

    Denver, Colorado, 80204

  • Porter Adventist Hospital

    Denver, Colorado, 80210

  • Exempla Saint Joseph Hospital

    Denver, Colorado, 80218

  • Presbyterian - Saint Lukes Medical Center - Health One

    Denver, Colorado, 80218

  • Rose Medical Center

    Denver, Colorado, 80220

  • Colorado Cancer Research Program CCOP

    Denver, Colorado, 80224-2522

  • Mercy Capitol

    Des Moines, Iowa, 50307

  • Iowa Methodist Medical Center

    Des Moines, Iowa, 50309

  • Iowa Oncology Research Association CCOP

    Des Moines, Iowa, 50309

  • Medical Oncology and Hematology Associates-Des Moines

    Des Moines, Iowa, 50309

  • Medical Oncology and Hematology Associates

    Des Moines, Iowa, 50314

  • Mercy Medical Center - Des Moines

    Des Moines, Iowa, 50314

  • Iowa Lutheran Hospital

    Des Moines, Iowa, 50316

  • Saint John Hospital and Medical Center

    Detroit, Michigan, 48236

  • Cancer Center of Kansas - Dodge City

    Dodge City, Kansas, 67801

  • Essentia Health Duluth Clinic CCOP

    Duluth, Minnesota, 55805

  • Essentia Health Saint Mary's Medical Center

    Duluth, Minnesota, 55805

  • Miller-Dwan Hospital

    Duluth, Minnesota, 55805

  • Midelfort Clinic-Clairemont Campus

    Eau Claire, Wisconsin, 54702

  • Mayo Clinic Health System Eau Claire Hospital - Luther Campus

    Eau Claire, Wisconsin, 54703

  • Fairview-Southdale Hospital

    Edina, Minnesota, 55435

  • Cancer Center of Kansas - El Dorado

    El Dorado, Kansas, 67042

  • Elkhart General Hospital

    Elkhart, Indiana, 46515

  • Hematology Oncology Center Incorporated

    Elyria, Ohio, 44035

  • Swedish Medical Center

    Englewood, Colorado, 80110

  • Green Bay Oncology - Escanaba

    Escanaba, Michigan, 49431

  • Eureka Hospital

    Eureka, Illinois, 61530

  • Sanford Clinic North-Fargo

    Fargo, North Dakota, 58122

  • Sanford Medical Center-Fargo

    Fargo, North Dakota, 58122

  • Blanchard Valley Hospital

    Findlay, Ohio, 45840

  • Hurley Medical Center

    Flint, Michigan, 48502

  • Genesys Regional Medical Center-West Flint Campus

    Flint, Michigan, 48532

  • Cancer Center of Kansas - Fort Scott

    Fort Scott, Kansas, 66701

  • Atrium Medical Center-Middletown Regional Hospital

    Franklin, Ohio, 45005-1066

  • Fredericksburg Oncology Inc

    Fredericksburg, Virginia, 22401

  • Unity Hospital

    Fridley, Minnesota, 55432

  • Galesburg Clinic

    Galesburg, Illinois, 61401

  • Galesburg Cottage Hospital

    Galesburg, Illinois, 61401

  • Altru Cancer Center

    Grand Forks, North Dakota, 58201

  • Saint Mary's Hospital and Regional Medical Center

    Grand Junction, Colorado, 81502

  • Berdeaux, Donald MD (UIA Investigator)

    Great Falls, Montana, 59405

  • Great Falls Clinic

    Great Falls, Montana, 59405

  • North Colorado Medical Center

    Greeley, Colorado, 80631

  • Green Bay Oncology at Saint Vincent Hospital

    Green Bay, Wisconsin, 54301-3526

  • Saint Vincent Hospital

    Green Bay, Wisconsin, 54301

  • Green Bay Oncology Limited at Saint Mary's Hospital

    Green Bay, Wisconsin, 54303

  • Saint Mary's Hospital

    Green Bay, Wisconsin, 54303

  • Wayne Hospital

    Greenville, Ohio, 45331

  • Mason District Hospital

    Havana, Illinois, 62644

  • Northern Montana Hospital

    Havre, Montana, 59501

  • Geisinger Medical Center-Cancer Center Hazelton

    Hazleton, Pennsylvania, 18201

  • Saint Peter's Community Hospital

    Helena, Montana, 59601

  • Hutchinson Area Health Care

    Hutchinson, Minnesota, 55350

  • Cancer Center of Kansas-Independence

    Independence, Kansas, 67301

  • Green Bay Oncology - Iron Mountain

    Iron Mountain, Michigan, 49801

  • Allegiance Health

    Jackson, Michigan, 49201

  • Mayo Clinic in Florida

    Jacksonville, Florida, 32224-9980

  • Glacier Oncology PLLC

    Kalispell, Montana, 59901

  • Kalispell Medical Oncology

    Kalispell, Montana, 59901

  • Kalispell Regional Medical Center

    Kalispell, Montana, 59901

  • Kettering Medical Center

    Kettering, Ohio, 45429

  • Cancer Center of Kansas-Kingman

    Kingman, Kansas, 67068

  • Community Howard Regional Health

    Kokomo, Indiana, 46904

  • Indiana University Health La Porte Hospital

    La Porte, Indiana, 46350

  • Sparrow Hospital

    Lansing, Michigan, 48912

  • Lawrence Memorial Hospital

    Lawrence, Kansas, 66044

  • Lima Memorial Hospital

    Lima, Ohio, 45804

  • Saint Mary Mercy Hospital

    Livonia, Michigan, 48154

  • Sky Ridge Medical Center

    Lone Tree, Colorado, 80124

  • Longmont United Hospital

    Longmont, Colorado, 80501

  • McKee Medical Center

    Loveland, Colorado, 80539

  • Mcdonough District Hospital

    Macomb, Illinois, 61455

  • Holy Family Memorial Hospital

    Manitowoc, Wisconsin, 54221

  • Immanuel-Saint Joseph Hospital-Mayo Health System

    Mankato, Minnesota, 56002

  • Minnesota Oncology Hematology PA-Maplewood

    Maplewood, Minnesota, 55109

  • Saint John's Hospital - Healtheast

    Maplewood, Minnesota, 55109

  • Bay Area Medical Center

    Marinette, Wisconsin, 54143

  • Mercy Medical Center - North Iowa

    Mason City, Iowa, 50401

  • Toledo Clinic Cancer Centers-Maumee

    Maumee, Ohio, 43537-1839

  • Saint Luke's Hospital

    Maumee, Ohio, 43537

  • Toledo Radiation Oncology at Northwest Ohio Onocolgy Center

    Maumee, Ohio, 43537

  • Abbott-Northwestern Hospital

    Minneapolis, Minnesota, 55407

  • Virginia Piper Cancer Institute

    Minneapolis, Minnesota, 55407

  • Hennepin County Medical Center

    Minneapolis, Minnesota, 55415

  • Saint Joseph Regional Medical Center-Mishawaka

    Mishawaka, Indiana, 46545-1470

  • Community Medical Hospital

    Missoula, Montana, 59801

  • Montana Cancer Specialists

    Missoula, Montana, 59802

  • Saint Patrick Hospital - Community Hospital

    Missoula, Montana, 59802

  • Guardian Oncology and Center for Wellness

    Missoula, Montana, 59804

  • Garneau, Stewart C MD (UIA Investigator)

    Moline, Illinois, 61265

  • Porubcin, Michael MD (UIA Investigator)

    Moline, Illinois, 61265

  • Sharis, Christine M MD (UIA Investigator)

    Moline, Illinois, 61265

  • Stoffel, Thomas J MD (UIA Investigator)

    Moline, Illinois, 61265

  • Holy Family Medical Center

    Monmouth, Illinois, 61462

  • Community Cancer Center of Monroe

    Monroe, Michigan, 48162

  • Mercy Memorial Hospital

    Monroe, Michigan, 48162

  • Cancer Center of Kansas - Newton

    Newton, Kansas, 67114

  • Bromenn Regional Medical Center

    Normal, Illinois, 61761

  • Community Cancer Center Foundation

    Normal, Illinois, 61761

  • Green Bay Oncology - Oconto Falls

    Oconto Falls, Wisconsin, 54154

  • Saint Charles Hospital

    Oregon, Ohio, 43616

  • Toledo Clinic Cancer Centers-Oregon

    Oregon, Ohio, 43616

  • Illinois CancerCare-Ottawa Clinic

    Ottawa, Illinois, 61350

  • Ottawa Regional Hospital and Healthcare Center

    Ottawa, Illinois, 61350

  • Cancer Center of Kansas - Parsons

    Parsons, Kansas, 67357

  • Pekin Cancer Treatment Center

    Pekin, Illinois, 61554

  • Pekin Hospital

    Pekin, Illinois, 61554

  • Methodist Medical Center of Illinois

    Peoria, Illinois, 61603

  • Proctor Hospital

    Peoria, Illinois, 61614

  • Illinois CancerCare-Peoria

    Peoria, Illinois, 61615

  • Illinois Oncology Research Association CCOP

    Peoria, Illinois, 61615

  • OSF Saint Francis Medical Center

    Peoria, Illinois, 61637

  • Illinois Valley Hospital

    Peru, Illinois, 61354

  • Saint Joseph Mercy Oakland

    Pontiac, Michigan, 48341-2985

  • Saint Joseph Mercy Port Huron

    Port Huron, Michigan, 48060

  • Adventist Medical Center

    Portland, Oregon, 97216

  • Cancer Center of Kansas - Pratt

    Pratt, Kansas, 67124

  • Perry Memorial Hospital

    Princeton, Illinois, 61356

  • Saint Mary Corwin Medical Center

    Pueblo, Colorado, 81004

  • Reid Hospital and Health Care Services

    Richmond, Indiana, 47374

  • North Memorial Medical Health Center

    Robbinsdale, Minnesota, 55422

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • Saint Mary's of Michigan

    Saginaw, Michigan, 48601

  • Lakeland Hospital

    Saint Joseph, Michigan, 49085

  • Metro-Minnesota CCOP

    Saint Louis Park, Minnesota, 55416

  • Park Nicollet Clinic - Saint Louis Park

    Saint Louis Park, Minnesota, 55416

  • Regions Hospital

    Saint Paul, Minnesota, 55101

  • United Hospital

    Saint Paul, Minnesota, 55102

  • Cancer Center of Kansas - Salina

    Salina, Kansas, 67401

  • North Coast Cancer Care

    Sandusky, Ohio, 44870

  • Mayo Clinic in Arizona

    Scottsdale, Arizona, 85259

  • Saint Francis Regional Medical Center

    Shakopee, Minnesota, 55379

  • Welch Cancer Center

    Sheridan, Wyoming, 82801

  • Siouxland Hematology Oncology Associates

    Sioux City, Iowa, 51101

  • Mercy Medical Center-Sioux City

    Sioux City, Iowa, 51104

  • Saint Luke's Regional Medical Center

    Sioux City, Iowa, 51104

  • Memorial Hospital of South Bend

    South Bend, Indiana, 46601

  • Northern Indiana Cancer Research Consortium

    South Bend, Indiana, 46601

  • South Bend Clinic

    South Bend, Indiana, 46617

  • Saint Margaret's Hospital

    Spring Valley, Illinois, 61362

  • Saint John's Hospital

    Springfield, Missouri, 65804

  • Missouri Baptist Medical Center

    St Louis, Missouri, 63131

  • Center for Cancer Care and Research

    St Louis, Missouri, 63141

  • Geisinger Medical Group

    State College, Pennsylvania, 16801

  • Green Bay Oncology - Sturgeon Bay

    Sturgeon Bay, Wisconsin, 54235

  • Flower Hospital

    Sylvania, Ohio, 43560

  • North Suburban Medical Center

    Thornton, Colorado, 80229

  • Mercy Hospital of Tiffin

    Tiffin, Ohio, 44883

  • The Toledo Hospital/Toledo Children's Hospital

    Toledo, Ohio, 43606

  • Saint Vincent Mercy Medical Center

    Toledo, Ohio, 43608

  • University of Toledo

    Toledo, Ohio, 43614

  • Toledo Community Hospital Oncology Program CCOP

    Toledo, Ohio, 43617

  • Mercy Cancer Center at Saint Anne Mercy Hospital

    Toledo, Ohio, 43623

  • Toledo Clinic Cancer Centers-Toledo

    Toledo, Ohio, 43623

  • Upper Valley Medical Center

    Troy, Ohio, 45373

  • Ridgeview Medical Center

    Waconia, Minnesota, 55387

  • Saint John Macomb-Oakland Hospital

    Warren, Michigan, 48093

  • Fulton County Health Center

    Wauseon, Ohio, 43567

  • Cancer Center of Kansas - Wellington

    Wellington, Kansas, 67152

  • Exempla Lutheran Medical Center

    Wheat Ridge, Colorado, 80033

  • Associates In Womens Health

    Wichita, Kansas, 67208

  • Cancer Center of Kansas-Wichita Medical Arts Tower

    Wichita, Kansas, 67208

  • Cancer Center of Kansas - Main Office

    Wichita, Kansas, 67214

  • Via Christi Regional Medical Center

    Wichita, Kansas, 67214

  • Wichita CCOP

    Wichita, Kansas, 67214

  • Geisinger Wyoming Valley

    Wilkes-Barre, Pennsylvania, 18711

  • Clinton Memorial Hospital

    Wilmington, Ohio, 45177

  • Cancer Center of Kansas - Winfield

    Winfield, Kansas, 67156

  • Minnesota Oncology and Hematology PA-Woodbury

    Woodbury, Minnesota, 55125

  • Greene Memorial Hospital

    Xenia, Ohio, 45385

Other trials in United States

About this study

Official title: Phase II Study of Sorafenib/Avastin® as Salvage Therapy in Patients With Metastatic Colorectal Cancer

This phase II trial is studying how well giving sorafenib together with bevacizumab works in treating patients with metastatic colorectal cancer. Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Sorafenib and bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving sorafenib together with bevacizumab may kill more tumor cells

Read the detailed description

PRIMARY OBJECTIVES:

  1. Evaluate proportion of patients who are progression-free at 3 months (in historic comparison with results for single-agent bevacizumab in ECOG 3200).

SECONDARY OBJECTIVES:

  1. Response rate (RR) II. Overall survival (OS) III. Safety IV. Feasibility

OUTLINE: This is a multicenter study.

Patients receive sorafenib tosylate orally twice daily on days 1-5 and 8-12 and bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. Blood samples are collected at baseline and then periodically during study treatment for laboratory biomarker and pharmacogenetic studies.

After completion of study treatment, patients are followed periodically for up to 2 years.

Being tested
sorafenib tosylate, bevacizumab
Medical subject headings
Colonic Neoplasms, Rectal Neoplasms

What participants receive

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

  • sorafenib tosylateDrug

    Also called BAY 43-9006, BAY 43-9006 Tosylate Salt, BAY 54-9085, Nexavar

    Given orally

  • bevacizumabBiological

    Also called anti-VEGF humanized monoclonal antibody, anti-VEGF monoclonal antibody, Avastin, rhuMAb VEGF

    Given IV

Study groups in NCT00826540
Study groupRoleWhat they receive
Treatment (sorafenib tosylate and bevacizumab)ExperimentalPatients receive sorafenib tosylate orally twice daily on days 1-5 and 8-12 and bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. Blood samples are collected at baseline and then periodically during study treatment for laboratory biomarker and pharmacogenetic studies
Receives: Drug: sorafenib tosylate; Biological: bevacizumab

What is being measured

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

  1. Progression-free Survival Rate

    The primary endpoint of this trial is progression free survival at 3 months. All patients meeting the eligibility criteria who have signed a consent form and have begun treatment will be considered evaluable. Patients lost to follow-up before 3 months (e.g., progression, refusing further treatment, etc.) will be considered treatment failures. All eligible patients will be followed until death or a minimum of 3 years. The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients.

    Progression is defined as at least a 20% increase in the sum of longest liameter of target lesions taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions.

    Measured: At 3 months

Secondary outcomes (3)

  1. Response Rate

    Number of patients reporting a partial response or complete response while on treatment

    Measured: 2 years

  2. Overall Survival

    The distribution of overall survival will be estimated using Kaplan-Meier methodology.

    Measured: 2 years

  3. Feasibility of Study Treatment

    Will be evaluated based on the number of patients who delayed treatment, omitted doses of treatment, or reduced treatment dose.

    Measured: 2 years

Timeline

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

  1. First posted22 Jan 2009 (estimated)
  2. Study startSep 2009
  3. Primary completionJan 2010
  4. Study completionFeb 2014

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
83 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00826540
Sponsor's protocol ID
NCCTG-N054C
Other IDs
NCI-2009-01177, U10CA025224, CDR0000632342
Status last verified
Dec 2025
First submitted
21 Jan 2009
Last updated
20 Jan 2026
Data monitoring committee
Yes

Publications

  • Xie H, Lafky JM, Morlan BW, Stella PJ, Dakhil SR, Gross GG, Loui WS, Hubbard JM, Alberts SR, Grothey A. Dual VEGF inhibition with sorafenib and bevacizumab as salvage therapy in metastatic colorectal cancer: results of the phase II North Central Cancer Treatment Group study N054C (Alliance). Ther Adv Med Oncol. 2020 Mar 6;12:1758835920910913. doi: 10.1177/1758835920910913. eCollection 2020.

    PubMed 32201506

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing sorafenib tosylate and bevacizumab in people with Recurrent Colon Cancer and Recurrent Rectal Cancer, run by Alliance for Clinical Trials in Oncology at 211 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 64 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 211 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Mar 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free Survival Rate (time frame: At 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00826540, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2026.

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