Colon Cancer Clinical Trial

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

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.

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Full Description

OBJECTIVES: I. Compare the overall survival of patients with metastatic colorectal carcinoma treated with fluorouracil and leucovorin calcium with vs without oxaliplatin vs oxaliplatin alone. II. Compare the response rate, time to tumor-related symptomatic worsening, time to disease progression, onset and duration of complete and partial responses, and duration of disease stabilization in patients treated with these regimens. III. Determine the safety profile of these regimens in these patients.

OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to Karnofsky performance status (50-60% vs 70-100%), number of metastatic organs (1 vs 2 or more), and LDH value (up to 1.5 times upper limit of normal (ULN) vs greater than 1.5 times ULN). Patients are randomized to one of three treatment arms. Arm I: Patients receive leucovorin calcium IV over 2 hours followed by fluorouracil IV continuously over 22 hours on days 1 and 2. Arm II: Patients receive oxaliplatin IV over 2 hours on day 1. Arm III: Patients receive oxaliplatin IV concurrently with leucovorin calcium IV over 2 hours followed by fluorouracil IV continuously over 22 hours on day 1. Leucovorin calcium and fluorouracil are administered alone on day 2 on the same schedule as on day 1. Treatment repeats every 2 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients are followed for 30 days, every 2 weeks for up to 3 months, and then every 3 months thereafter.

PROJECTED ACCRUAL: A total of 786 patients (262 per arm) will be accrued for this study within 12 months.

View Eligibility Criteria

Eligibility Criteria

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

Study is for people with:

Colon Cancer

Phase:

Phase 3

Study ID:

NCT00008281

Recruitment Status:

Unknown status

Sponsor:

Sanofi

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There are 130 Locations for this study

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Comprehensive Cancer Institute of Huntsville
Huntsville Alabama, 35801, United States
Oncology Center at Providence Park
Mobile Alabama, 36608, United States
Arizona Clinical Research Center
Tucson Arizona, 85712, United States
Arkansas Oncology Associates, P.A.
Little Rock Arkansas, 72207, United States
Offices of Richard Shapiro, Benjamin Stafford, and Sharon J. Yee
Arcadia California, 91007, United States
California Cancer Care, Inc.
Greenbrae California, 94904, United States
Medical Oncology Internal Medicine
Los Angeles California, 90067, United States
Bay Area Tumor Institute
Oakland California, 94609, United States
Medical Oncology Care Associates
Orange California, 92668, United States
P.M.K. Medical Group, Inc.
Oxnard California, 93030, United States
Cancer and Blood Institute of the Desert
Rancho Mirage California, 92270, United States
Kaiser Permanente-Southern California Permanente Medical Group
San Diego California, 92120, United States
Kaiser Permanente Medical Center - Vallejo
Vallejo California, 94589, United States
Kaiser Permanente - Denver
Denver Colorado, 80205, United States
Rocky Mountain Cancer Center
Denver Colorado, 80218, United States
Northwestern Connecticut Oncology-Hematology Associates
Torrington Connecticut, 06790, United States
Lombardi Cancer Center
Washington District of Columbia, 20007, United States
Comprehensive Cancer Care Specialists of Boca Raton
Boca Raton Florida, 33428, United States
Center for Hematology-Oncology
Boca Raton Florida, 33486, United States
Florida Cancer Specialists
Fort Myers Florida, 33901, United States
University of Florida Health Science Center
Gainesville Florida, 32610, United States
Memorial Regional Hospital Comprehensive Cancer Center
Hollywood Florida, 33021, United States
Florida Community Cancer Center
Hudson Florida, 34667, United States
North Florida Hematology & Oncology Associates
Jacksonville Florida, 32204, United States
Hematology/Oncology Associates
Jacksonville Florida, 32216, United States
Lakeland Regional Medical Center
Lakeland Florida, 33804, United States
Mount Sinai Comprehensive Cancer Center
Miami Florida, 33140, United States
Oncology-Hematology Group of South Florida
Miami Florida, 33176, United States
Ocala Oncology Center
Ocala Florida, 34474, United States
Office of Thomas A. Marsland
Orange Park Florida, 32073, United States
Florida Hospital Cancer Institute
Orlando Florida, 32804, United States
Office of Barry S. Berman
Orlando Florida, 32806, United States
Memorial Hospital West
Pembroke Pines Florida, 33028, United States
Hematology-Oncology Associates, PA
Pensacola Florida, 32501, United States
Hematology/Oncology Associates
Port Saint Lucie Florida, 34952, United States
Oncology & Hematology Associates of West Broward
Tamarac Florida, 33321, United States
Office of Ron D. Schiff
Tampa Florida, 33613, United States
Hematology and Oncology Consultants
Titusville Florida, 32796, United States
Dreyer Medical Clinic
Aurora Illinois, 60506, United States
Northwestern Medical Faculty Foundation
Chicago Illinois, 60611, United States
Hematology Oncology Associates of Illinois-Highland Park
Highland Park Illinois, 60035, United States
Lutheran General Cancer Care Center
Park Ridge Illinois, 60068, United States
Oncology and Hematology Associates
Greenfield Indiana, 46140, United States
Cancer Care Center
New Albany Indiana, 47150, United States
Oncology Associates of Cedar Rapids
Cedar Rapids Iowa, 52403, United States
University of Kansas Medical Center
Kansas City Kansas, 66160, United States
Cancer Center of Kansas - Wichita
Wichita Kansas, 67214, United States
Albert B. Chandler Medical Center, University of Kentucky
Lexington Kentucky, 40536, United States
James Graham Brown Cancer Center
Louisville Kentucky, 40202, United States
Baton Rouge General Medical Center
Baton Rouge Louisiana, 70821, United States
Louisiana Oncology Associates
Lafayette Louisiana, 70506, United States
Physicians Office
Metairie Louisiana, 70006, United States
Louisiana State University School of Medicine
New Orleans Louisiana, 70112, United States
Maine Center for Cancer Medicine and Blood Disorders
Scarborough Maine, 04074, United States
Barbara Ann Karmanos Cancer Institute
Detroit Michigan, 48201, United States
Parker Hughes Cancer Center
Roseville Minnesota, 55113, United States
Park Nicollet Clinic
St. Louis Park Minnesota, 55416, United States
Columbia Comprehensive Cancer Care Clinic
Columbia Missouri, 65201, United States
Missouri Cancer Associates
Columbia Missouri, 65201, United States
Midwest Oncology Consortium
Kansas City Missouri, 64111, United States
Missouri Baptist Cancer Center
Saint Louis Missouri, 63131, United States
St. John's Mercy Medical Center
Saint Louis Missouri, 63141, United States
Missouri Cancer Care, P.C.
St. Charles Missouri, 63301, United States
Cooper Hospital/University Medical Center
Voorhees New Jersey, 08043, United States
Veterans Affairs Medical Center - Albany
Albany New York, 12208, United States
Albert Einstein Comprehensive Cancer Center
Bronx New York, 10461, United States
Roswell Park Cancer Institute
Buffalo New York, 14263, United States
North Shore Hematology/Oncology Associates, P.C.
East Setauket New York, 11733, United States
Capitol District Hematology Oncology Associates, P.C.
Latham New York, 12110, United States
St. Vincents Comprehensive Cancer Center
New York New York, 10011, United States
NYU School of Medicine's Kaplan Comprehensive Cancer Center
New York New York, 10016, United States
Interlakes Oncology/Hematology PC
Rochester New York, 14623, United States
State University of New York Health Sciences Center - Stony Brook
Stony Brook New York, 11790, United States
New York Medical College
Valhalla New York, 10595, United States
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill North Carolina, 27599, United States
Regional Hematology Oncology Associates
Durham North Carolina, 27704, United States
Raleigh Hematology/Oncology Associates - Wake Practice
Raleigh North Carolina, 27609, United States
Piedmont Hematology-Oncology Associates-Triad
Winston-Salem North Carolina, 27103, United States
Hematology Oncology Consultants Inc
Columbus Ohio, 43235, United States
Dayton Oncology/Hematology P.A.
Dayton Ohio, 45439, United States
Naz Medical Center
Midwest City Oklahoma, 73310, United States
Cancer Care Associates
Tulsa Oklahoma, 74136, United States
Willamette Valley Cancer Center
Eugene Oregon, 97401, United States
Abington Memorial Hospital
Abington Pennsylvania, 19001, United States
Oncology/Hematology Associates - Beaver
Beaver Pennsylvania, 15009, United States
University of Pennsylvania Cancer Center
Philadelphia Pennsylvania, 19104, United States
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
Philadelphia Pennsylvania, 19107, United States
Pennsylvania Oncology Hematology Associates
Philadelphia Pennsylvania, 19107, United States
University of Pittsburgh Cancer Institute
Pittsburgh Pennsylvania, 15213, United States
Cancer Centers of the Carolinas
Greenville South Carolina, 29605, United States
Erlanger Health Systems
Chattanooga Tennessee, 37403, United States
Baptist Regional Cancer Center - Knoxville
Knoxville Tennessee, 37901, United States
West Clinic, P.C.
Memphis Tennessee, 38117, United States
Memphis Cancer Center
Memphis Tennessee, 38119, United States
St. Thomas Medical Center
Nashville Tennessee, 37205, United States
Vanderbilt-Ingram Cancer Center
Nashville Tennessee, 37232, United States
Lone Star Oncology
Austin Texas, 78759, United States
Texas Oncology P.A.
Dallas Texas, 75230, United States
Center for Oncology Research and Treatment, Medical City Hospital
Dallas Texas, 75230, United States
Simmons Cancer Center - Dallas
Dallas Texas, 75235, United States
Texas Cancer Center Southwest
Dallas Texas, 75235, United States
Texas Oncology PA (TOPA) at Baylor-Sammons
Dallas Texas, 75246, United States
Texas Oncology, P.A.
Fort Worth Texas, 76104, United States
Texas Oncology, P.A.
Garland Texas, 75042, United States
South Texas Regional Cancer Centers - McAllen
McAllen Texas, 78503, United States
Texas Oncology - Mesquite
Mesqutie Texas, 75150, United States
Baptist Health System Cancer Program
San Antonio Texas, 78205, United States
San Antonio Tumor and Blood Clinic
San Antonio Texas, 78217, United States
Tyler Cancer Center
Tyler Texas, 75702, United States
Huntsman Cancer Institute
Salt Lake City Utah, 84112, United States
Hematology-Oncology Associates of Frederiksburg, Inc.
Fredericksburg Virginia, 22401, United States
Virginia Oncology Associates - Newport News
Newport News Virginia, 23606, United States
Hematology & Oncology Associates of Virginia
Richmond Virginia, 23226, United States
Virginia Mason Medical Center
Seattle Washington, 98111, United States
Swedish Medical Center
Seattle Washington, 98122, United States
Cancer Care Northwest
Spokane Washington, 99202, United States
Northwest Cancer Specialists
Vancouver Washington, 98664, United States
University of Wisconsin Comprehensive Cancer Center
Madison Wisconsin, 53792, United States
Advanced Health Care
Milwaukee Wisconsin, 53209, United States
UW Cancer Center Wausau Hospital
Wausau Wisconsin, 54401, United States
Ivinson Memorial Hospital
Laramie Wyoming, 82070, United States
Tom Baker Cancer Center - Calgary
Calgary Alberta, T2N 4, Canada
University of Alberta
Edmonton Alberta, T6G 2, Canada
St. Boniface General Hospital
Winnipeg Manitoba, R2H 2, Canada
Nova Scotia Cancer Centre
Halifax Nova Scotia, B3H 1, Canada
Belleville General Hospital
Belleville Ontario, K8N 5, Canada
Cancer Care Ontario-London Regional Cancer Centre
London Ontario, N6A 4, Canada
Peterborough Oncology Clinic
Peterborough Ontario, K9H 7, Canada
Toronto Sunnybrook Regional Cancer Centre
Toronto Ontario, M4N 3, Canada
Mount Sinai Hospital - Toronto
Toronto Ontario, M5G 1, Canada
Princess Margaret Hospital
Toronto Ontario, M5G 2, Canada
Notre Dame Hospital
Montreal Quebec, H4L 2, Canada
Centre Hospitalier Regional de Rimouski
Rimouski Quebec, G5L 5, Canada
Saskatoon Cancer Centre
Saskatoon Saskatchewan, S7N 4, Canada

How clear is this clinincal trial information?

Study is for people with:

Colon Cancer

Phase:

Phase 3

Study ID:

NCT00008281

Recruitment Status:

Unknown status

Sponsor:


Sanofi

How clear is this clinincal trial information?

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