Irinotecan and Cetuximab With or Without Bevacizumab in Treating Patients With Metastatic Colorectal Cancer That Progressed During First-Line Therapy

NCT ID: NCT00499369

Last Updated: 2014-07-31

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Study Completion Date

2012-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This randomized phase III trial is studying giving irinotecan and cetuximab together with bevacizumab to see how well it works compared with giving irinotecan and cetuximab alone in treating patients with metastatic colorectal cancer that progressed during first-line therapy. Drugs used in chemotherapy, such as irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab and 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. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. It is not yet known whether irinotecan and cetuximab are more effective with or without bevacizumab in treating metastatic colorectal cancer.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

PRIMARY OBJECTIVES:

I. Compare progression-free survival of patients with metastatic colorectal cancer that progressed on first-line therapy comprising bevacizumab and FOLFOX, OPTIMOX, or XELOX treated with irinotecan hydrochloride-based chemotherapy and cetuximab with vs without bevacizumab.

II. Compare overall survival of patients treated with these regimens. III. Compare objective tumor response (confirmed and unconfirmed, complete and partial response) in patients with measurable disease treated with these regimens.

IV. Compare the tolerability and safety profile of these regimens in these patients.

OUTLINE: This is a multicenter, randomized study. Patients are stratified according to Zubrod performance status (0 vs 1 or 2), discontinuation of oxaliplatin during first-line therapy (yes vs no), planned concurrent chemotherapy (FOLFIRI vs single-agent irinotecan hydrochloride), and time from last dose of bevacizumab (14-42 days vs \>= 43 days).

All patients receive 1 of the following chemotherapy regimens:

SINGLE AGENT IRINOTECAN HYDROCHLORIDE: Patients receive irinotecan hydrochloride intravenously (IV) over 90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.

FOLFIRI: Patients receive irinotecan hydrochloride IV over 90 minutes and leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV continuously over 46-48 hours on days 1 and 2. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.

Patients are then randomized to 1 of 3 treatment arms.

ARM I: Patients receive single-agent irinotecan hydrochloride or FOLFIRI as outlined above and cetuximab IV over 1-2 hours on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen) in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive single-agent irinotecan hydrochloride or FOLFIRI as outlined above and cetuximab as in arm I. Patients also receive bevacizumab IV over 30 minutes on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen) in the absence of disease progression or unacceptable toxicity.

ARM III (closed to accrual as of 4/20/2009): Patients receive single-agent irinotecan hydrochloride or FOLFIRI as outlined above and cetuximab as in arm I. Patients also receive a higher dose of bevacizumab (higher than in arm II) IV over 30 minutes on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen) in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 6 months for 2 years and then once a year for 3 years.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Recurrent Colon Cancer Recurrent Rectal Cancer Stage IVA Colon Cancer Stage IVA Rectal Cancer Stage IVB Colon Cancer Stage IVB Rectal Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Arm I (chemotherapy, cetuximab)

Patients receive single-agent irinotecan hydrochloride IV or FOLFIRI IV. They also receive cetuximab IV over 1-2 hours on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen) in the absence of disease progression or unacceptable toxicity.

Group Type EXPERIMENTAL

irinotecan hydrochloride

Intervention Type DRUG

Given IV

leucovorin calcium

Intervention Type DRUG

Given IV

fluorouracil

Intervention Type DRUG

Given IV

cetuximab

Intervention Type BIOLOGICAL

Given IV

Arm II (chemotherapy, cetuximab, bevacizumab)

Patients receive single-agent irinotecan hydrochloride or FOLFIRI AND cetuximab as in arm I. Patients also receive bevacizumab IV over 30 minutes on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen) in the absence of disease progression or unacceptable toxicity.

Group Type EXPERIMENTAL

irinotecan hydrochloride

Intervention Type DRUG

Given IV

leucovorin calcium

Intervention Type DRUG

Given IV

fluorouracil

Intervention Type DRUG

Given IV

cetuximab

Intervention Type BIOLOGICAL

Given IV

bevacizumab

Intervention Type BIOLOGICAL

Given IV

Arm III (closed to accrual as of 4/20/2009)

Patients receive single-agent irinotecan hydrochloride or FOLFIRI AND cetuximab as in arm I. Patients also receive a higher dose of bevacizumab (higher than in arm II) IV over 30 minutes on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen) in the absence of disease progression or unacceptable toxicity.

Group Type EXPERIMENTAL

irinotecan hydrochloride

Intervention Type DRUG

Given IV

leucovorin calcium

Intervention Type DRUG

Given IV

fluorouracil

Intervention Type DRUG

Given IV

cetuximab

Intervention Type BIOLOGICAL

Given IV

bevacizumab

Intervention Type BIOLOGICAL

Given IV

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

irinotecan hydrochloride

Given IV

Intervention Type DRUG

leucovorin calcium

Given IV

Intervention Type DRUG

fluorouracil

Given IV

Intervention Type DRUG

cetuximab

Given IV

Intervention Type BIOLOGICAL

bevacizumab

Given IV

Intervention Type BIOLOGICAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Campto Camptosar CPT-11 irinotecan U-101440E CF CFR LV 5-fluorouracil 5-Fluracil 5-FU C225 C225 monoclonal antibody IMC-C225 MOAB C225 monoclonal antibody C225 anti-VEGF humanized monoclonal antibody anti-VEGF monoclonal antibody Avastin rhuMAb VEGF

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients must have metastatic colorectal cancer that has been histologically or cytologically confirmed; confirmation may be from either the primary tumor or a metastasis; patients must have wild type KRAS
* Patients must be registered within 28 days of documented disease progression on first line chemotherapy with bevacizumab plus either FOLFOX, OPTIMOX, or XELOX; this progression must have occurred within 90 days after the last dose of bevacizumab; patients who discontinued oxaliplatin, continued with 5-FU/LV or capecitabine and bevacizumab and then had subsequent progression while on fluoropyrimidine and bevacizumab are eligible; patients who discontinued bevacizumab due to adverse events in the first-line setting are not eligible
* Measurable or nonmeasurable disease
* At least 14 days must have elapsed since the last dose of first line chemotherapy and bevacizumab
* Patients must not have received prior treatment with irinotecan (either as adjuvant or metastatic treatment)
* Patients must have no history of prior treatment with cetuximab or other agents targeting VEGF or EGFR (except for bevacizumab)
* Prior radiotherapy is allowed, provided at least 28 days have elapsed since the last treatment; all adverse events related to radiation therapy must be resolved
* Prior surgery is allowed, provided at least 28 days have elapsed since any major surgery and patient has recovered from all effects
* Zubrod performance status 0-2
* Absolute neutrophil count (ANC) \>= 1,500/mm\^3
* Platelet count \>= 100,000/mm\^3
* Hemoglobin \>= 9 g/dL
* Total bilirubin =\< 1.5 times upper limit of normal (ULN)
* Serum glutamic oxaloacetic transaminase (SGOT) or serum glutamic pyruvate transaminase (SGPT) =\< 2.5 x IULN; if there are known liver metastases, SGOT or SGPT must be =\< 5 x IULN; these results must be obtained within 28 days prior to registration
* Serum creatinine =\< IULN or measured or estimated creatinine clearance \>= 60 mL/min
* Patients must not have a history or known presence of brain metastasis
* Patients may be on full dose anticoagulation with warfarin provided that the patient has an acceptable International Normalized Ratio (INR) (between 2 and 3), obtained within 28 days prior to registration
* No clinically relevant bleeding diathesis or coagulopathy
* Patients must not have experienced nephrotic range proteinuria from prior bevacizumab therapy; urine protein must be screened by urine analysis for Urine Protein Creatinine (UPC) ratio; for UPC ratio \> 0.5, 24-hour urine protein must be obtained and the level must be \< 1,000 mg for patient enrollment; urine protein and creatinine used in calculating the UPC ratio must be obtained within 28 days prior to registration
* No uncontrolled high blood pressure (BP) (i.e., systolic BP \> 150 mm Hg and diastolic BP \> 90 mm Hg)
* No cardiovascular event within the past 6 months, including any of the following:

* Arterial thrombosis
* Unstable angina
* Myocardial infarction
* Cerebrovascular accident
* Patients must not have New York Heart Association (NYHA) \>= Grade 2 congestive heart failure
* Patients must not have unstable symptomatic arrhythmia requiring medication; (patients with chronic, controlled arrhythmias such as atrial fibrillation or paroxysmal supraventricular tachycardia \[PSVT\] are eligible)
* No clinically significant peripheral vascular disease
* No serious or nonhealing active wound, ulcer, or bone fracture
* No history of gastrointestinal (GI) perforation while on prior bevacizumab
* No significant bleeding episodes (e.g., hemoptysis or upper or lower GI bleeding) within the past 6 months unless the source of bleeding has been resected
* No known hypersensitivity to bevacizumab or known potential hypersensitivity to cetuximab
* No other concurrent chemotherapy, hormonal therapy, radiotherapy, immunotherapy, or any other type of anticancer treatment
* Due to the possibility of harm to a fetus or nursing infant from this treatment regimen, patients must not be pregnant or nursing; women and men of reproductive potential must have agreed to use an effective contraceptive method
* No other malignancy within the past 5 years except for adequately treated basal or squamous cell skin cancer or cervical cancer in situ
* All 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
* At the time of patient registration, the treating institution's name and identification (ID) number must be provided to the Data Operations Center in Seattle in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered into the data base
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

North Central Cancer Treatment Group

NETWORK

Sponsor Role collaborator

Cancer and Leukemia Group B

NETWORK

Sponsor Role collaborator

Eastern Cooperative Oncology Group

NETWORK

Sponsor Role collaborator

NCIC Clinical Trials Group

NETWORK

Sponsor Role collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Philip Gold

Role: PRINCIPAL_INVESTIGATOR

SWOG Cancer Research Network

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Saint Edward Mercy Medical Center

Fort Smith, Arkansas, United States

Site Status

Providence Saint Joseph Medical Center/Disney Family Cancer Center

Burbank, California, United States

Site Status

East Bay Radiation Oncology Center

Castro Valley, California, United States

Site Status

Eden Hospital Medical Center

Castro Valley, California, United States

Site Status

Valley Medical Oncology Consultants-Castro Valley

Castro Valley, California, United States

Site Status

City of Hope Medical Center

Duarte, California, United States

Site Status

Northbay Cancer Center

Fairfield, California, United States

Site Status

Valley Medical Oncology Consultants-Fremont

Fremont, California, United States

Site Status

Glendale Memorial Hospital and Health Center

Glendale, California, United States

Site Status

Marin General Hospital

Greenbrae, California, United States

Site Status

Saint Rose Hospital

Hayward, California, United States

Site Status

University of Southern California

Los Angeles, California, United States

Site Status

Fremont - Rideout Cancer Center

Marysville, California, United States

Site Status

Highland General Hospital

Oakland, California, United States

Site Status

Alta Bates Summit Medical Center - Summit Campus

Oakland, California, United States

Site Status

Bay Area Breast Surgeons Inc

Oakland, California, United States

Site Status

Bay Area Tumor Institute CCOP

Oakland, California, United States

Site Status

Larry G Strieff MD Medical Corporation

Oakland, California, United States

Site Status

Tom K Lee Inc

Oakland, California, United States

Site Status

Palchak David MD

Pismo Beach, California, United States

Site Status

Valley Care Health System - Pleasanton

Pleasanton, California, United States

Site Status

Valley Medical Oncology Consultants

Pleasanton, California, United States

Site Status

Sutter Roseville Medical Center

Roseville, California, United States

Site Status

UC Davis Comprehensive Cancer Center

Sacramento, California, United States

Site Status

Doctors Medical Center- JC Robinson Regional Cancer Center

San Pablo, California, United States

Site Status

Tahoe Forest Cancer Center

Truckee, California, United States

Site Status

The Medical Center of Aurora

Aurora, Colorado, United States

Site Status

Boulder Community Hospital

Boulder, Colorado, United States

Site Status

Penrose-Saint Francis Healthcare

Colorado Springs, Colorado, United States

Site Status

Memorial Hospital Colorado Springs

Colorado Springs, Colorado, United States

Site Status

Porter Adventist Hospital

Denver, Colorado, United States

Site Status

Exempla Saint Joseph Hospital

Denver, Colorado, United States

Site Status

Presbyterian - Saint Lukes Medical Center - Health One

Denver, Colorado, United States

Site Status

Rose Medical Center

Denver, Colorado, United States

Site Status

Colorado Cancer Research Program CCOP

Denver, Colorado, United States

Site Status

Swedish Medical Center

Englewood, Colorado, United States

Site Status

Saint Mary's Hospital and Regional Medical Center

Grand Junction, Colorado, United States

Site Status

North Colorado Medical Center

Greeley, Colorado, United States

Site Status

Saint Anthony Hospital

Lakewood, Colorado, United States

Site Status

Sky Ridge Medical Center

Lone Tree, Colorado, United States

Site Status

Longmont United Hospital

Longmont, Colorado, United States

Site Status

McKee Medical Center

Loveland, Colorado, United States

Site Status

Saint Mary Corwin Medical Center

Pueblo, Colorado, United States

Site Status

North Suburban Medical Center

Thornton, Colorado, United States

Site Status

Exempla Lutheran Medical Center

Wheat Ridge, Colorado, United States

Site Status

The Hospital of Central Connecticut

New Britain, Connecticut, United States

Site Status

Bayhealth Medical Center at Kent General

Dover, Delaware, United States

Site Status

Lombardi Comprehensive Cancer Center at Georgetown University

Washington D.C., District of Columbia, United States

Site Status

Edna Williams Cancer Center at the Baptist Cancer Institute

Jacksonville, Florida, United States

Site Status

Mayo Clinic in Florida

Jacksonville, Florida, United States

Site Status

University of Miami Miller School of Medicine-Sylvester Cancer Center

Miami, Florida, United States

Site Status

Space Coast Cancer Centers-Titusville

Titusville, Florida, United States

Site Status

Piedmont Hospital

Atlanta, Georgia, United States

Site Status

Atlanta Regional CCOP

Atlanta, Georgia, United States

Site Status

Northside Hospital

Atlanta, Georgia, United States

Site Status

Saint Joseph's Hospital of Atlanta

Atlanta, Georgia, United States

Site Status

Well Star Cobb Hospital

Austell, Georgia, United States

Site Status

John B Amos Cancer Center

Columbus, Georgia, United States

Site Status

Atlanta VA Medical Center

Decatur, Georgia, United States

Site Status

Dekalb Medical Center

Decatur, Georgia, United States

Site Status

Gwinnett Medical Center

Lawrenceville, Georgia, United States

Site Status

Wellstar Kennestone Hospital

Marietta, Georgia, United States

Site Status

Southern Regional Medical Center

Riverdale, Georgia, United States

Site Status

Harbin Clinic Medical Oncology and Clinical Research

Rome, Georgia, United States

Site Status

South Georgia Medical Center

Valdosta, Georgia, United States

Site Status

Rush - Copley Medical Center

Aurora, Illinois, United States

Site Status

Saint Joseph Medical Center

Bloomington, Illinois, United States

Site Status

Graham Hospital Association

Canton, Illinois, United States

Site Status

Memorial Hospital

Carthage, Illinois, United States

Site Status

John H Stroger Jr Hospital of Cook County

Chicago, Illinois, United States

Site Status

Resurrection Healthcare

Chicago, Illinois, United States

Site Status

Decatur Memorial Hospital

Decatur, Illinois, United States

Site Status

Crossroads Cancer Center

Effingham, Illinois, United States

Site Status

Saint Anthony Memorial Hospital

Effingham, Illinois, United States

Site Status

Eureka Hospital

Eureka, Illinois, United States

Site Status

Galesburg Cottage Hospital

Galesburg, Illinois, United States

Site Status

Illinois CancerCare Galesburg

Galesburg, Illinois, United States

Site Status

Mason District Hospital

Havana, Illinois, United States

Site Status

Hopedale Medical Complex - Hospital

Hopedale, Illinois, United States

Site Status

Joliet Oncology-Hematology Associates Limited

Joliet, Illinois, United States

Site Status

Adventist La Grange Memorial Hospital

La Grange, Illinois, United States

Site Status

Mcdonough District Hospital

Macomb, Illinois, United States

Site Status

Bromenn Regional Medical Center

Normal, Illinois, United States

Site Status

Community Cancer Center Foundation

Normal, Illinois, United States

Site Status

Illinois CancerCare-Ottawa Clinic

Ottawa, Illinois, United States

Site Status

Ottawa Regional Hospital and Healthcare Center

Ottawa, Illinois, United States

Site Status

Pekin Cancer Treatment Center

Pekin, Illinois, United States

Site Status

Pekin Hospital

Pekin, Illinois, United States

Site Status

Methodist Medical Center of Illinois

Peoria, Illinois, United States

Site Status

Proctor Hospital

Peoria, Illinois, United States

Site Status

Illinois CancerCare-Peoria

Peoria, Illinois, United States

Site Status

Illinois Oncology Research Association CCOP

Peoria, Illinois, United States

Site Status

OSF Saint Francis Medical Center

Peoria, Illinois, United States

Site Status

Illinois Valley Hospital

Peru, Illinois, United States

Site Status

Perry Memorial Hospital

Princeton, Illinois, United States

Site Status

Saint Margaret's Hospital

Spring Valley, Illinois, United States

Site Status

Memorial Medical Center

Springfield, Illinois, United States

Site Status

Carle Cancer Center

Urbana, Illinois, United States

Site Status

Carle Clinic-Urbana Main

Urbana, Illinois, United States

Site Status

Elkhart Clinic

Elkhart, Indiana, United States

Site Status

Michiana Hematology Oncology PC-Elkhart

Elkhart, Indiana, United States

Site Status

Elkhart General Hospital

Elkhart, Indiana, United States

Site Status

Fort Wayne Medical Oncology and Hematology Inc-Parkview

Fort Wayne, Indiana, United States

Site Status

Community Howard Regional Health

Kokomo, Indiana, United States

Site Status

Indiana University Health La Porte Hospital

La Porte, Indiana, United States

Site Status

Franciscan Saint Anthony Health-Michigan City

Michigan City, Indiana, United States

Site Status

Michiana Hematology Oncology PC-Mishawaka

Mishawaka, Indiana, United States

Site Status

Saint Joseph Regional Medical Center-Mishawaka

Mishawaka, Indiana, United States

Site Status

Michiana Hematology Oncology PC-Plymouth

Plymouth, Indiana, United States

Site Status

Memorial Hospital of South Bend

South Bend, Indiana, United States

Site Status

Michiana Hematology Oncology PC-South Bend

South Bend, Indiana, United States

Site Status

South Bend Clinic

South Bend, Indiana, United States

Site Status

Northern Indiana Cancer Research Consortium

South Bend, Indiana, United States

Site Status

Michiana Hematology Oncology-PC Westville

Westville, Indiana, United States

Site Status

McFarland Clinic PC-William R Bliss Cancer Center

Ames, Iowa, United States

Site Status

Hematology Oncology Associates-Quad Cities

Bettendorf, Iowa, United States

Site Status

Cedar Rapids Oncology Association

Cedar Rapids, Iowa, United States

Site Status

Mercy Hospital

Cedar Rapids, Iowa, United States

Site Status

Oncology Associates at Mercy Medical Center

Cedar Rapids, Iowa, United States

Site Status

Medical Oncology and Hematology Associates-West Des Moines

Clive, Iowa, United States

Site Status

Mercy Capitol

Des Moines, Iowa, United States

Site Status

Iowa Methodist Medical Center

Des Moines, Iowa, United States

Site Status

Iowa Oncology Research Association CCOP

Des Moines, Iowa, United States

Site Status

Medical Oncology and Hematology Associates-Des Moines

Des Moines, Iowa, United States

Site Status

Medical Oncology and Hematology Associates-Laurel

Des Moines, Iowa, United States

Site Status

Mercy Medical Center - Des Moines

Des Moines, Iowa, United States

Site Status

Iowa Lutheran Hospital

Des Moines, Iowa, United States

Site Status

Siouxland Hematology Oncology Associates

Sioux City, Iowa, United States

Site Status

Mercy Medical Center-Sioux City

Sioux City, Iowa, United States

Site Status

Saint Luke's Regional Medical Center

Sioux City, Iowa, United States

Site Status

Covenant Medical Center

Waterloo, Iowa, United States

Site Status

Cancer Center of Kansas - Chanute

Chanute, Kansas, United States

Site Status

Cancer Center of Kansas - Dodge City

Dodge City, Kansas, United States

Site Status

Cancer Center of Kansas - El Dorado

El Dorado, Kansas, United States

Site Status

Cancer Center of Kansas - Fort Scott

Fort Scott, Kansas, United States

Site Status

Hays Medical Center

Hays, Kansas, United States

Site Status

Promise Regional Medical Center-Hutchinson

Hutchinson, Kansas, United States

Site Status

Cancer Center of Kansas-Independence

Independence, Kansas, United States

Site Status

University of Kansas Medical Center

Kansas City, Kansas, United States

Site Status

Cancer Center of Kansas-Kingman

Kingman, Kansas, United States

Site Status

Lawrence Memorial Hospital

Lawrence, Kansas, United States

Site Status

Cancer Center of Kansas-Liberal

Liberal, Kansas, United States

Site Status

Cancer Center of Kansas - Newton

Newton, Kansas, United States

Site Status

Olathe Cancer Center

Olathe, Kansas, United States

Site Status

Cancer Center of Kansas - Parsons

Parsons, Kansas, United States

Site Status

Via Christi Hospital-Pittsburg

Pittsburg, Kansas, United States

Site Status

Cancer Center of Kansas - Pratt

Pratt, Kansas, United States

Site Status

Cancer Center of Kansas - Salina

Salina, Kansas, United States

Site Status

Salina Regional Health Center

Salina, Kansas, United States

Site Status

Stormont-Vail Regional Health Center

Topeka, Kansas, United States

Site Status

Saint Francis Hospital and Medical Center - Topeka

Topeka, Kansas, United States

Site Status

Cancer Center of Kansas - Wellington

Wellington, Kansas, United States

Site Status

Associates In Womens Health

Wichita, Kansas, United States

Site Status

Cancer Center of Kansas-Wichita Medical Arts Tower

Wichita, Kansas, United States

Site Status

Cancer Center of Kansas - Main Office

Wichita, Kansas, United States

Site Status

Via Christi Regional Medical Center

Wichita, Kansas, United States

Site Status

Wichita CCOP

Wichita, Kansas, United States

Site Status

Cancer Center of Kansas - Winfield

Winfield, Kansas, United States

Site Status

Doctors Carrol, Sheth, Raghavan

Louisville, Kentucky, United States

Site Status

Baton Rouge General Medical Center

Baton Rouge, Louisiana, United States

Site Status

Harold Alfond Center for Cancer Care

Augusta, Maine, United States

Site Status

Eastern Maine Medical Center

Bangor, Maine, United States

Site Status

Memorial Hospital at Easton - Shore Regional Cancer Center

Easton, Maryland, United States

Site Status

Frederick Memorial Hospital

Frederick, Maryland, United States

Site Status

Sturdy Memorial Hospital

Attleboro, Massachusetts, United States

Site Status

Boston Medical Center

Boston, Massachusetts, United States

Site Status

Bixby Medical Center

Adrian, Michigan, United States

Site Status

Hickman Cancer Center

Adrian, Michigan, United States

Site Status

Saint Joseph Mercy Hospital

Ann Arbor, Michigan, United States

Site Status

Michigan Cancer Research Consortium Community Clinical Oncology Program

Ann Arbor, Michigan, United States

Site Status

Oakwood Hospital

Dearborn, Michigan, United States

Site Status

Henry Ford Hospital

Detroit, Michigan, United States

Site Status

Saint John Hospital and Medical Center

Detroit, Michigan, United States

Site Status

Green Bay Oncology - Escanaba

Escanaba, Michigan, United States

Site Status

Hurley Medical Center

Flint, Michigan, United States

Site Status

Genesys Regional Medical Center-West Flint Campus

Flint, Michigan, United States

Site Status

Grand Rapids Clinical Oncology Program

Grand Rapids, Michigan, United States

Site Status

Holland Community Hospital

Holland, Michigan, United States

Site Status

Green Bay Oncology - Iron Mountain

Iron Mountain, Michigan, United States

Site Status

Allegiance Health

Jackson, Michigan, United States

Site Status

Sparrow Hospital

Lansing, Michigan, United States

Site Status

Saint Mary Mercy Hospital

Livonia, Michigan, United States

Site Status

Community Cancer Center of Monroe

Monroe, Michigan, United States

Site Status

Mercy Memorial Hospital

Monroe, Michigan, United States

Site Status

Mercy Health Partners-Hackley Campus

Muskegon, Michigan, United States

Site Status

Michiana Hematology Oncology PC-Niles

Niles, Michigan, United States

Site Status

Saint Joseph Mercy Oakland

Pontiac, Michigan, United States

Site Status

Saint Joseph Mercy Port Huron

Port Huron, Michigan, United States

Site Status

William Beaumont Hospital-Royal Oak

Royal Oak, Michigan, United States

Site Status

Saint Mary's of Michigan

Saginaw, Michigan, United States

Site Status

Lakeland Hospital

Saint Joseph, Michigan, United States

Site Status

Marie Yeager Cancer Center

Saint Joseph, Michigan, United States

Site Status

Saint John Macomb-Oakland Hospital

Warren, Michigan, United States

Site Status

Fairview Ridges Hospital

Burnsville, Minnesota, United States

Site Status

Mercy Hospital

Coon Rapids, Minnesota, United States

Site Status

Essentia Health Duluth Clinic CCOP

Duluth, Minnesota, United States

Site Status

Essentia Health Saint Mary's Medical Center

Duluth, Minnesota, United States

Site Status

Miller-Dwan Hospital

Duluth, Minnesota, United States

Site Status

Fairview-Southdale Hospital

Edina, Minnesota, United States

Site Status

Etzell, Paul S MD (UIA Investigator)

Fergus Falls, Minnesota, United States

Site Status

Swenson, Wade II, MD (UIA Investigator)

Fergus Falls, Minnesota, United States

Site Status

Unity Hospital

Fridley, Minnesota, United States

Site Status

Hutchinson Area Health Care

Hutchinson, Minnesota, United States

Site Status

Meeker County Memorial Hospital

Litchfield, Minnesota, United States

Site Status

Mayo Clinic Health Systems-Mankato

Mankato, Minnesota, United States

Site Status

Minnesota Oncology Hematology PA-Maplewood

Maplewood, Minnesota, United States

Site Status

Saint John's Hospital - Healtheast

Maplewood, Minnesota, United States

Site Status

Abbott-Northwestern Hospital

Minneapolis, Minnesota, United States

Site Status

Virginia Piper Cancer Institute

Minneapolis, Minnesota, United States

Site Status

Hennepin County Medical Center

Minneapolis, Minnesota, United States

Site Status

North Memorial Medical Health Center

Robbinsdale, Minnesota, United States

Site Status

Mayo Clinic

Rochester, Minnesota, United States

Site Status

Metro-Minnesota CCOP

Saint Louis Park, Minnesota, United States

Site Status

Park Nicollet Clinic - Saint Louis Park

Saint Louis Park, Minnesota, United States

Site Status

Regions Hospital

Saint Paul, Minnesota, United States

Site Status

Saint Joseph's Hospital - Healtheast

Saint Paul, Minnesota, United States

Site Status

United Hospital

Saint Paul, Minnesota, United States

Site Status

Saint Francis Regional Medical Center

Shakopee, Minnesota, United States

Site Status

Ridgeview Medical Center

Waconia, Minnesota, United States

Site Status

Rice Memorial Hospital

Willmar, Minnesota, United States

Site Status

Minnesota Oncology and Hematology PA-Woodbury

Woodbury, Minnesota, United States

Site Status

Woodwinds Health Campus

Woodbury, Minnesota, United States

Site Status

Singing River Hospital

Pascagoula, Mississippi, United States

Site Status

Southeast Missouri Hospital

Cape Girardeau, Missouri, United States

Site Status

Veterans Administration

Columbia, Missouri, United States

Site Status

University of Missouri - Ellis Fischel

Columbia, Missouri, United States

Site Status

Mercy Hospital Springfield

Springfield, Missouri, United States

Site Status

Saint Louis University Hospital

St Louis, Missouri, United States

Site Status

Missouri Baptist Medical Center

St Louis, Missouri, United States

Site Status

Center for Cancer Care and Research

St Louis, Missouri, United States

Site Status

Montana Cancer Consortium CCOP

Billings, Montana, United States

Site Status

Northern Rockies Radiation Oncology Center

Billings, Montana, United States

Site Status

Saint Vincent Healthcare

Billings, Montana, United States

Site Status

Hematology-Oncology Centers of the Northern Rockies PC

Billings, Montana, United States

Site Status

Billings Clinic

Billings, Montana, United States

Site Status

Bozeman Deaconess Cancer Center

Bozeman, Montana, United States

Site Status

Bozeman Deaconess Hospital

Bozeman, Montana, United States

Site Status

Saint James Community Hospital and Cancer Treatment Center

Butte, Montana, United States

Site Status

Benefis Healthcare- Sletten Cancer Institute

Great Falls, Montana, United States

Site Status

Berdeaux, Donald MD (UIA Investigator)

Great Falls, Montana, United States

Site Status

Great Falls Clinic

Great Falls, Montana, United States

Site Status

Northern Montana Hospital

Havre, Montana, United States

Site Status

Saint Peter's Community Hospital

Helena, Montana, United States

Site Status

Glacier Oncology PLLC

Kalispell, Montana, United States

Site Status

Kalispell Medical Oncology

Kalispell, Montana, United States

Site Status

Kalispell Regional Medical Center

Kalispell, Montana, United States

Site Status

Community Medical Hospital

Missoula, Montana, United States

Site Status

Montana Cancer Specialists

Missoula, Montana, United States

Site Status

Saint Patrick Hospital - Community Hospital

Missoula, Montana, United States

Site Status

Guardian Oncology and Center for Wellness

Missoula, Montana, United States

Site Status

Good Samaritan Hospital

Kearney, Nebraska, United States

Site Status

Nebraska Cancer Research Center

Lincoln, Nebraska, United States

Site Status

Fox Chase Cancer Center at Virtua Memorial Hospital of Burlington County

Mount Holly, New Jersey, United States

Site Status

Sparta Cancer Treatment Center

Sparta, New Jersey, United States

Site Status

Virtua West Jersey Hospital Voorhees

Voorhees Township, New Jersey, United States

Site Status

Veterans Affairs Western New York Health Care System-Buffalo

Buffalo, New York, United States

Site Status

Finger Lakes Hematology and Oncology

Clifton Springs, New York, United States

Site Status

Adirondack Cancer Center

Glens Falls, New York, United States

Site Status

Glens Falls Hospital

Glens Falls, New York, United States

Site Status

Orange Regional Medical Center

Middletown, New York, United States

Site Status

Montefiore Medical Center

The Bronx, New York, United States

Site Status

Southeastern Medical Oncology Center-Goldsboro

Goldsboro, North Carolina, United States

Site Status

Margaret R Pardee Memorial Hospital

Hendersonville, North Carolina, United States

Site Status

Kinston Medical Specialists PA

Kinston, North Carolina, United States

Site Status

FirstHealth of the Carolinas-Moore Regional Hosiptal

Pinehurst, North Carolina, United States

Site Status

Rutherford Hospital

Rutherfordton, North Carolina, United States

Site Status

Bismarck Cancer Center

Bismarck, North Dakota, United States

Site Status

Mid Dakota Clinic

Bismarck, North Dakota, United States

Site Status

Saint Alexius Medical Center

Bismarck, North Dakota, United States

Site Status

Sanford Bismarck Medical Center

Bismarck, North Dakota, United States

Site Status

Altru Cancer Center

Grand Forks, North Dakota, United States

Site Status

Akron General Medical Center

Akron, Ohio, United States

Site Status

Mary Rutan Hospital

Bellefontaine, Ohio, United States

Site Status

Toledo Clinic Cancer Centers-Bowling Green

Bowling Green, Ohio, United States

Site Status

Mercy Medical Center

Canton, Ohio, United States

Site Status

Aultman Health Foundation

Canton, Ohio, United States

Site Status

Adena Regional Medical Center

Chillicothe, Ohio, United States

Site Status

North Coast Cancer Care-Clyde

Clyde, Ohio, United States

Site Status

Riverside Methodist Hospital

Columbus, Ohio, United States

Site Status

Columbus CCOP

Columbus, Ohio, United States

Site Status

Grant Medical Center

Columbus, Ohio, United States

Site Status

Mount Carmel Health Center West

Columbus, Ohio, United States

Site Status

Doctors Hospital

Columbus, Ohio, United States

Site Status

Grady Memorial Hospital

Delaware, Ohio, United States

Site Status

Community Health Partners Regional Medical Center

Elyria, Ohio, United States

Site Status

Hematology Oncology Center Incorporated

Elyria, Ohio, United States

Site Status

Fremont Memorial Hospital

Fremont, Ohio, United States

Site Status

Fairfield Medical Center

Lancaster, Ohio, United States

Site Status

Lima Memorial Hospital

Lima, Ohio, United States

Site Status

Mansfield General Hospital-MedCentral Health System

Mansfield, Ohio, United States

Site Status

Marietta Memorial Hospital

Marietta, Ohio, United States

Site Status

Saint Luke's Hospital

Maumee, Ohio, United States

Site Status

Toledo Clinic Cancer Centers-Maumee

Maumee, Ohio, United States

Site Status

Toledo Radiation Oncology at Northwest Ohio Onocolgy Center

Maumee, Ohio, United States

Site Status

Knox Community Hospital

Mount Vernon, Ohio, United States

Site Status

Licking Memorial Hospital

Newark, Ohio, United States

Site Status

Fisher-Titus Medical Center

Norwalk, Ohio, United States

Site Status

Saint Charles Hospital

Oregon, Ohio, United States

Site Status

Toledo Clinic Cancer Centers-Oregon

Oregon, Ohio, United States

Site Status

Firelands Regional Medical Center

Sandusky, Ohio, United States

Site Status

North Coast Cancer Care

Sandusky, Ohio, United States

Site Status

Springfield Regional Medical Center

Springfield, Ohio, United States

Site Status

Flower Hospital

Sylvania, Ohio, United States

Site Status

Mercy Hospital of Tiffin

Tiffin, Ohio, United States

Site Status

The Toledo Hospital/Toledo Children's Hospital

Toledo, Ohio, United States

Site Status

Saint Vincent Mercy Medical Center

Toledo, Ohio, United States

Site Status

University of Toledo

Toledo, Ohio, United States

Site Status

Toledo Community Hospital Oncology Program CCOP

Toledo, Ohio, United States

Site Status

Mercy Saint Anne Hospital

Toledo, Ohio, United States

Site Status

Toledo Clinic Cancer Centers-Toledo

Toledo, Ohio, United States

Site Status

Fulton County Health Center

Wauseon, Ohio, United States

Site Status

Saint Ann's Hospital

Westerville, Ohio, United States

Site Status

Genesis HealthCare System

Zanesville, Ohio, United States

Site Status

Bay Area Hospital

Coos Bay, Oregon, United States

Site Status

Adventist Medical Center

Portland, Oregon, United States

Site Status

Geisinger Medical Center

Danville, Pennsylvania, United States

Site Status

Mercy Fitzgerald Hospital

Darby, Pennsylvania, United States

Site Status

Geisinger Medical Center-Cancer Center Hazelton

Hazleton, Pennsylvania, United States

Site Status

Central PA Hematology-Medical Oncology Associates PC

Lemoyne, Pennsylvania, United States

Site Status

Riddle Hospital

Media, Pennsylvania, United States

Site Status

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States

Site Status

Allegheny Cancer Center at Allegheny General Hospital

Pittsburgh, Pennsylvania, United States

Site Status

Hematology and Oncology Associates of North East Pennsylvania

Scranton, Pennsylvania, United States

Site Status

Geisinger Medical Group

State College, Pennsylvania, United States

Site Status

Associates In Hematology Oncology PC-Upland

Upland, Pennsylvania, United States

Site Status

Geisinger Wyoming Valley

Wilkes-Barre, Pennsylvania, United States

Site Status

AnMed Health Hospital

Anderson, South Carolina, United States

Site Status

South Carolina Oncology Associates PA

Columbia, South Carolina, United States

Site Status

Greenville Health System Cancer Institute-Easley

Easley, South Carolina, United States

Site Status

McLeod Regional Medical Center

Florence, South Carolina, United States

Site Status

Greenville Health System Cancer Institute-Andrews

Greenville, South Carolina, United States

Site Status

Greenville Health System Cancer Institute-Butternut

Greenville, South Carolina, United States

Site Status

Greenville Health System Cancer Institute-Faris

Greenville, South Carolina, United States

Site Status

Greenville Memorial Hospital

Greenville, South Carolina, United States

Site Status

Greenville Health System Cancer Instutite/Greenville CCOP

Greenville, South Carolina, United States

Site Status

Self Regional Healthcare

Greenwood, South Carolina, United States

Site Status

Cancer Centers of the Carolinas-Greer Medical Oncology

Greer, South Carolina, United States

Site Status

Greenville Health System Cancer Institute-Greer

Greer, South Carolina, United States

Site Status

Greenville Health System Cancer Institute-Seneca

Seneca, South Carolina, United States

Site Status

Spartanburg Regional Medical Center

Spartanburg, South Carolina, United States

Site Status

Upstate Carolina CCOP

Spartanburg, South Carolina, United States

Site Status

Greenville Health System Cancer Institute-Spartanburg

Spartanburg, South Carolina, United States

Site Status

Rapid City Regional Hospital

Rapid City, South Dakota, United States

Site Status

University of Tennessee - Memphis

Memphis, Tennessee, United States

Site Status

The Don and Sybil Harrington Cancer Center

Amarillo, Texas, United States

Site Status

Scott and White Memorial Hospital

Temple, Texas, United States

Site Status

Fredericksburg Oncology Inc

Fredericksburg, Virginia, United States

Site Status

PeaceHealth Saint Joseph Medical Center

Bellingham, Washington, United States

Site Status

Harrison HealthPartners Hematology and Oncology-Bremerton

Bremerton, Washington, United States

Site Status

Columbia Basin Hematology and Oncology PLLC

Kennewick, Washington, United States

Site Status

Skagit Valley Hospital

Mount Vernon, Washington, United States

Site Status

Harrison HealthPartners Hematology and Oncology-Poulsbo

Poulsbo, Washington, United States

Site Status

Harborview Medical Center

Seattle, Washington, United States

Site Status

Minor and James Medical PLLC

Seattle, Washington, United States

Site Status

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Seattle, Washington, United States

Site Status

Group Health Cooperative-Seattle

Seattle, Washington, United States

Site Status

Swedish Medical Center-First Hill

Seattle, Washington, United States

Site Status

The Polyclinic

Seattle, Washington, United States

Site Status

University of Washington Medical Center

Seattle, Washington, United States

Site Status

United General Hospital

Sedro-Woolley, Washington, United States

Site Status

Cancer Care Northwest - Spokane South

Spokane, Washington, United States

Site Status

Evergreen Hematology and Oncology PS

Spokane, Washington, United States

Site Status

Wenatchee Valley Medical Center

Wenatchee, Washington, United States

Site Status

West Virginia University Charleston

Charleston, West Virginia, United States

Site Status

Camden-Clark Memorial Hospital

Parkersburg, West Virginia, United States

Site Status

Midelfort Clinic-Clairemont Campus

Eau Claire, Wisconsin, United States

Site Status

Mayo Clinic Health System Eau Claire Hospital - Luther Campus

Eau Claire, Wisconsin, United States

Site Status

Aurora Cancer Care-Southern Lakes

Elkhorn, Wisconsin, United States

Site Status

Green Bay Oncology at Saint Vincent Hospital

Green Bay, Wisconsin, United States

Site Status

Saint Vincent Hospital

Green Bay, Wisconsin, United States

Site Status

Green Bay Oncology Limited at Saint Mary's Hospital

Green Bay, Wisconsin, United States

Site Status

Saint Mary's Hospital

Green Bay, Wisconsin, United States

Site Status

Mercy Health System

Janesville, Wisconsin, United States

Site Status

Holy Family Memorial Hospital

Manitowoc, Wisconsin, United States

Site Status

Bay Area Medical Center

Marinette, Wisconsin, United States

Site Status

Columbia Saint Mary's Hospital - Ozaukee

Mequon, Wisconsin, United States

Site Status

Columbia Saint Mary's Water Tower Medical Commons

Milwaukee, Wisconsin, United States

Site Status

Medical Consultants Limited

Milwaukee, Wisconsin, United States

Site Status

Green Bay Oncology - Oconto Falls

Oconto Falls, Wisconsin, United States

Site Status

Green Bay Oncology - Sturgeon Bay

Sturgeon Bay, Wisconsin, United States

Site Status

Rocky Mountain Oncology

Casper, Wyoming, United States

Site Status

Welch Cancer Center

Sheridan, Wyoming, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

NCI-2009-00784

Identifier Type: REGISTRY

Identifier Source: secondary_id

CALGB-SWOG-S0600

Identifier Type: -

Identifier Source: secondary_id

SWOG-S0600

Identifier Type: -

Identifier Source: secondary_id

CDR0000551934

Identifier Type: -

Identifier Source: secondary_id

ECOG-SWOG-S0600

Identifier Type: -

Identifier Source: secondary_id

CAN-NCIC-SWOG-S0600

Identifier Type: -

Identifier Source: secondary_id

NCCTG-SWOG-S0600

Identifier Type: -

Identifier Source: secondary_id

S0600

Identifier Type: OTHER

Identifier Source: secondary_id

S0600

Identifier Type: OTHER

Identifier Source: secondary_id

U10CA032102

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NCI-2009-00784

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.