Comparison of Three Chemotherapy Regimens in Treating Patients With Metastatic Colorectal Cancer

NCT00008281 | Unknown Phase 3

• 3 other identifiers: CDR0000068394SANOFI-EFC4584BRCC-00036
• Study Type: interventional
• Target: N/A
• Locations: 2 countries
• Sites: 134

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which regimen of chemotherapy is more effective for metastatic colorectal cancer. PURPOSE: Phase III trial to compare the effectiveness of three chemotherapy regimens in treating patients who have metastatic colorectal cancer.

Conditions

Colorectal Cancer

Keywords

stage IV colon cancer; stage IV rectal cancer; recurrent colon cancer; recurrent rectal cancer; adenocarcinoma of the colon; adenocarcinoma of the rectum

Interventions

FOLFOX regimen DRUG

fluorouracil DRUG

leucovorin calcium DRUG

oxaliplatin DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed metastatic adenocarcinoma of the colon or rectum that is not amenable to potentially curative therapy (e.g., inoperable metastatic disease) At least 1 unidimensionally measurable lesion at least 20 mm in diameter by conventional CT or MRI scan or at least 10 mm in diameter by spiral CT scan Progressive disease by CT or MRI scan during or no more than 6 months after the last dose of prior first-line irinotecan, fluorouracil, and leucovorin calcium (Saltz regimen) for metastatic disease PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 50-100% Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) AST and ALT no greater than 2 times ULN (no greater than 5 times ULN if liver metastases present) Alkaline phosphatase no greater than 2 times ULN (no greater than 3 times ULN if liver metastases present) Renal: Creatinine no greater than 1.5 times ULN Cardiovascular: No uncontrolled high blood pressure No unstable angina, symptomatic congestive heart failure, or serious cardiac arrhythmia No New York Heart Association class III or IV heart disease No history of cardiac toxicities with prior fluorouracil and leucovorin calcium No myocardial infarction within the past 6 months Pulmonary: No interstitial pneumonia or extensive and symptomatic fibrosis of the lung Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 6 months after study No known dihydropyrimidine dehydrogenase deficiency No allergy to platinum-containing drugs No history of intolerance to study anti-emetics (e.g., 5-HT3 antagonists) No known peripheral neuropathy (absence of deep tendon reflexes as sole deficiency allowed) No uncontrolled diabetes No active infection No other active malignancy originating from primary site other than colon or rectum PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics One and only 1 prior chemotherapy regimen for metastatic disease consisting of first-line irinotecan, fluorouracil, and leucovorin calcium (Saltz regimen) Prior adjuvant fluorouracil with leucovorin calcium allowed At least 3 weeks since prior chemotherapy for metastatic disease and recovered No prior adjuvant irinotecan No prior oxaliplatin Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy to study lesions unless evidence of progressive disease within the radiotherapy port At least 3 weeks since prior radiotherapy Surgery: See Disease Characteristics At least 4 weeks since prior major surgery and recovered Prior surgical resection of primary tumor or metastases allowed Other: At least 30 days since prior investigational drugs No other concurrent investigational agents No other concurrent anti-cancer therapy No concurrent participation in other investigational trials

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (134)

Comprehensive Cancer Institute of Huntsville

Huntsville, Alabama, 35801, United States

Location

Oncology Center at Providence Park

Mobile, Alabama, 36608, United States

Location

Arizona Clinical Research Center

Tucson, Arizona, 85712, United States

Location

Arkansas Oncology Associates, P.A.

Little Rock, Arkansas, 72207, United States

Location

Offices of Richard Shapiro, Benjamin Stafford, and Sharon J. Yee

Arcadia, California, 91007-7678, United States

Location

California Cancer Care, Inc.

Greenbrae, California, 94904, United States

Location

Medical Oncology Internal Medicine

Los Angeles, California, 90067, United States

Location

Bay Area Tumor Institute

Oakland, California, 94609, United States

Location

Medical Oncology Care Associates

Orange, California, 92668, United States

Location

P.M.K. Medical Group, Inc.

Oxnard, California, 93030, United States

Location

Cancer and Blood Institute of the Desert

Rancho Mirage, California, 92270, United States

Location

Kaiser Permanente-Southern California Permanente Medical Group

San Diego, California, 92120, United States

Location

Kaiser Permanente Medical Center - Vallejo

Vallejo, California, 94589, United States

Location

Kaiser Permanente - Denver

Denver, Colorado, 80205, United States

Location

Rocky Mountain Cancer Center

Denver, Colorado, 80218, United States

Location

Northwestern Connecticut Oncology-Hematology Associates

Torrington, Connecticut, 06790, United States

Location

Lombardi Cancer Center

Washington D.C., District of Columbia, 20007, United States

Location

Comprehensive Cancer Care Specialists of Boca Raton

Boca Raton, Florida, 33428, United States

Location

Center for Hematology-Oncology

Boca Raton, Florida, 33486, United States

Location

Florida Cancer Specialists

Fort Myers, Florida, 33901, United States

Location

University of Florida Health Science Center

Gainesville, Florida, 32610-0296, United States

Location

Memorial Regional Hospital Comprehensive Cancer Center

Hollywood, Florida, 33021, United States

Location

Florida Community Cancer Center

Hudson, Florida, 34667, United States

Location

North Florida Hematology & Oncology Associates

Jacksonville, Florida, 32204, United States

Location

Hematology/Oncology Associates

Jacksonville, Florida, 32216, United States

Location

Lakeland Regional Medical Center

Lakeland, Florida, 33804, United States

Location

Mount Sinai Comprehensive Cancer Center

Miami, Florida, 33140, United States

Location

Oncology-Hematology Group of South Florida

Miami, Florida, 33176, United States

Location

Ocala Oncology Center

Ocala, Florida, 34474, United States

Location

Office of Thomas A. Marsland

Orange Park, Florida, 32073, United States

Location

Florida Hospital Cancer Institute

Orlando, Florida, 32804, United States

Location

Office of Barry S. Berman

Orlando, Florida, 32806, United States

Location

Memorial Hospital West

Pembroke Pines, Florida, 33028, United States

Location

Hematology-Oncology Associates, PA

Pensacola, Florida, 32501, United States

Location

Hematology/Oncology Associates

Port Saint Lucie, Florida, 34952, United States

Location

Oncology & Hematology Associates of West Broward

Tamarac, Florida, 33321, United States

Location

Office of Ron D. Schiff

Tampa, Florida, 33613, United States

Location

Hematology and Oncology Consultants

Titusville, Florida, 32796, United States

Location

Dreyer Medical Clinic

Aurora, Illinois, 60506, United States

Location

Northwestern Medical Faculty Foundation

Chicago, Illinois, 60611, United States

Location

Hematology Oncology Associates of Illinois-Highland Park

Highland Park, Illinois, 60035, United States

Location

Lutheran General Cancer Care Center

Park Ridge, Illinois, 60068, United States

Location

Oncology and Hematology Associates

Greenfield, Indiana, 46140, United States

Location

Cancer Care Center

New Albany, Indiana, 47150, United States

Location

Oncology Associates of Cedar Rapids

Cedar Rapids, Iowa, 52403, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160-7357, United States

Location

Cancer Center of Kansas - Wichita

Wichita, Kansas, 67214, United States

Location

Albert B. Chandler Medical Center, University of Kentucky

Lexington, Kentucky, 40536-0084, United States

Location

James Graham Brown Cancer Center

Louisville, Kentucky, 40202, United States

Location

Baton Rouge General Medical Center

Baton Rouge, Louisiana, 70821-2511, United States

Location

Louisiana Oncology Associates

Lafayette, Louisiana, 70506, United States

Location

Physicians Office

Metairie, Louisiana, 70006, United States

Location

Louisiana State University School of Medicine

New Orleans, Louisiana, 70112-2822, United States

Location

Maine Center for Cancer Medicine and Blood Disorders

Scarborough, Maine, 04074, United States

Location

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201-1379, United States

Location

Parker Hughes Cancer Center

Roseville, Minnesota, 55113, United States

Location

Park Nicollet Clinic

Saint Louis Park, Minnesota, 55416, United States

Location

Columbia Comprehensive Cancer Care Clinic

Columbia, Missouri, 65201, United States

Location

Missouri Cancer Associates

Columbia, Missouri, 65201, United States

Location

Midwest Oncology Consortium

Kansas City, Missouri, 64111, United States

Location

Missouri Cancer Care, P.C.

Saint Charles, Missouri, 63301, United States

Location

Missouri Baptist Cancer Center

St Louis, Missouri, 63131, United States

Location

St. John's Mercy Medical Center

St Louis, Missouri, 63141, United States

Location

Cooper Hospital/University Medical Center

Voorhees Township, New Jersey, 08043, United States

Location

Veterans Affairs Medical Center - Albany

Albany, New York, 12208, United States

Location

Roswell Park Cancer Institute

Buffalo, New York, 14263-0001, United States

Location

North Shore Hematology/Oncology Associates, P.C.

East Setauket, New York, 11733, United States

Location

Capitol District Hematology Oncology Associates, P.C.

Latham, New York, 12110-0610, United States

Location

St. Vincents Comprehensive Cancer Center

New York, New York, 10011, United States

Location

NYU School of Medicine's Kaplan Comprehensive Cancer Center

New York, New York, 10016, United States

Location

Interlakes Oncology/Hematology PC

Rochester, New York, 14623, United States

Location

State University of New York Health Sciences Center - Stony Brook

Stony Brook, New York, 11790-7775, United States

Location

Albert Einstein Comprehensive Cancer Center

The Bronx, New York, 10461, United States

Location

New York Medical College

Valhalla, New York, 10595, United States

Location

Lineberger Comprehensive Cancer Center, UNC

Chapel Hill, North Carolina, 27599-7295, United States

Location

Regional Hematology Oncology Associates

Durham, North Carolina, 27704, United States

Location

Raleigh Hematology/Oncology Associates - Wake Practice

Raleigh, North Carolina, 27609, United States

Location

Piedmont Hematology-Oncology Associates-Triad

Winston-Salem, North Carolina, 27103, United States

Location

Hematology Oncology Consultants Inc

Columbus, Ohio, 43235, United States

Location

Dayton Oncology/Hematology P.A.

Dayton, Ohio, 45439, United States

Location

Naz Medical Center

Midwest City, Oklahoma, 73310, United States

Location

Cancer Care Associates

Tulsa, Oklahoma, 74136, United States

Location

Willamette Valley Cancer Center

Eugene, Oregon, 97401-8122, United States

Location

Abington Memorial Hospital

Abington, Pennsylvania, 19001, United States

Location

Oncology/Hematology Associates - Beaver

Beaver, Pennsylvania, 15009, United States

Location

University of Pennsylvania Cancer Center

Philadelphia, Pennsylvania, 19104-4283, United States

Location

Kimmel Cancer Center of Thomas Jefferson University - Philadelphia

Philadelphia, Pennsylvania, 19107-5541, United States

Location

Pennsylvania Oncology Hematology Associates

Philadelphia, Pennsylvania, 19107, United States

Location

University of Pittsburgh Cancer Institute

Pittsburgh, Pennsylvania, 15213-3489, United States

Location

Cancer Centers of the Carolinas

Greenville, South Carolina, 29605, United States

Location

Erlanger Health Systems

Chattanooga, Tennessee, 37403, United States

Location

Baptist Regional Cancer Center - Knoxville

Knoxville, Tennessee, 37901, United States

Location

West Clinic, P.C.

Memphis, Tennessee, 38117, United States

Location

Memphis Cancer Center

Memphis, Tennessee, 38119, United States

Location

St. Thomas Medical Center

Nashville, Tennessee, 37205, United States

Location

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232-6838, United States

Location

Lone Star Oncology

Austin, Texas, 78759, United States

Location

Texas Oncology P.A.

Dallas, Texas, 75230-2503, United States

Location

Center for Oncology Research and Treatment, Medical City Hospital

Dallas, Texas, 75230, United States

Location

Simmons Cancer Center - Dallas

Dallas, Texas, 75235-9154, United States

Location

Texas Cancer Center Southwest

Dallas, Texas, 75235, United States

Location

Texas Oncology PA (TOPA) at Baylor-Sammons

Dallas, Texas, 75246, United States

Location

Texas Oncology, P.A.

Fort Worth, Texas, 76104, United States

Location

Texas Oncology, P.A.

Garland, Texas, 75042, United States

Location

South Texas Regional Cancer Centers - McAllen

McAllen, Texas, 78503, United States

Location

Texas Oncology - Mesquite

Mesqutie, Texas, 75150, United States

Location

Baptist Health System Cancer Program

San Antonio, Texas, 78205, United States

Location

San Antonio Tumor and Blood Clinic

San Antonio, Texas, 78217, United States

Location

Tyler Cancer Center

Tyler, Texas, 75702, United States

Location

Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States

Location

Hematology-Oncology Associates of Frederiksburg, Inc.

Fredericksburg, Virginia, 22401, United States

Location

Virginia Oncology Associates - Newport News

Newport News, Virginia, 23606, United States

Location

Hematology & Oncology Associates of Virginia

Richmond, Virginia, 23226, United States

Location

Virginia Mason Medical Center

Seattle, Washington, 98111, United States

Location

Swedish Medical Center

Seattle, Washington, 98122-4307, United States

Location

Cancer Care Northwest

Spokane, Washington, 99202, United States

Location

Northwest Cancer Specialists

Vancouver, Washington, 98664, United States

Location

University of Wisconsin Comprehensive Cancer Center

Madison, Wisconsin, 53792-6164, United States

Location

Advanced Health Care

Milwaukee, Wisconsin, 53209, United States

Location

UW Cancer Center Wausau Hospital

Wausau, Wisconsin, 54401, United States

Location

Ivinson Memorial Hospital

Laramie, Wyoming, 82070, United States

Location

Tom Baker Cancer Center - Calgary

Calgary, Alberta, T2N 4N2, Canada

Location

University of Alberta

Edmonton, Alberta, T6G 2R7, Canada

Location

St. Boniface General Hospital

Winnipeg, Manitoba, R2H 2A6, Canada

Location

Nova Scotia Cancer Centre

Halifax, Nova Scotia, B3H 1V7, Canada

Location

Belleville General Hospital

Belleville, Ontario, K8N 5K5, Canada

Location

Cancer Care Ontario-London Regional Cancer Centre

London, Ontario, N6A 4L6, Canada

Location

Peterborough Oncology Clinic

Peterborough, Ontario, K9H 7B6, Canada

Location

Toronto Sunnybrook Regional Cancer Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Mount Sinai Hospital - Toronto

Toronto, Ontario, M5G 1X5, Canada

Location

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

Notre Dame Hospital

Montreal, Quebec, H4L 2M1, Canada

Location

Centre Hospitalier Regional de Rimouski

Rimouski, Quebec, G5L 5T1, Canada

Location

Saskatoon Cancer Centre

Saskatoon, Saskatchewan, S7N 4H4, Canada

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Colonic Neoplasms; Rectal Neoplasms

Interventions

Folfox protocol; Fluorouracil; Leucovorin; Oxaliplatin

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes; Coordination Complexes; Organic Chemicals

Study Officials

• Mace L. Rothenberg, MD, FACP

  Vanderbilt-Ingram Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 6, 2001
• First Posted: February 16, 2004
• Study Start: October 1, 2000
• Last Updated: January 6, 2014

Record last verified: 2002-04

Locations

CA (13); US (121)