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.
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.
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
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There are 130 Locations for this study
Huntsville Alabama, 35801, United States
Mobile Alabama, 36608, United States
Tucson Arizona, 85712, United States
Little Rock Arkansas, 72207, United States
Arcadia California, 91007, United States
Greenbrae California, 94904, United States
Los Angeles California, 90067, United States
Oakland California, 94609, United States
Orange California, 92668, United States
Oxnard California, 93030, United States
Rancho Mirage California, 92270, United States
San Diego California, 92120, United States
Vallejo California, 94589, United States
Denver Colorado, 80205, United States
Denver Colorado, 80218, United States
Torrington Connecticut, 06790, United States
Washington District of Columbia, 20007, United States
Boca Raton Florida, 33428, United States
Boca Raton Florida, 33486, United States
Fort Myers Florida, 33901, United States
Gainesville Florida, 32610, United States
Hollywood Florida, 33021, United States
Hudson Florida, 34667, United States
Jacksonville Florida, 32204, United States
Jacksonville Florida, 32216, United States
Lakeland Florida, 33804, United States
Miami Florida, 33140, United States
Miami Florida, 33176, United States
Ocala Florida, 34474, United States
Orange Park Florida, 32073, United States
Orlando Florida, 32804, United States
Orlando Florida, 32806, United States
Pembroke Pines Florida, 33028, United States
Pensacola Florida, 32501, United States
Port Saint Lucie Florida, 34952, United States
Tamarac Florida, 33321, United States
Tampa Florida, 33613, United States
Titusville Florida, 32796, United States
Aurora Illinois, 60506, United States
Chicago Illinois, 60611, United States
Highland Park Illinois, 60035, United States
Park Ridge Illinois, 60068, United States
Greenfield Indiana, 46140, United States
New Albany Indiana, 47150, United States
Cedar Rapids Iowa, 52403, United States
Kansas City Kansas, 66160, United States
Wichita Kansas, 67214, United States
Lexington Kentucky, 40536, United States
Louisville Kentucky, 40202, United States
Baton Rouge Louisiana, 70821, United States
Lafayette Louisiana, 70506, United States
Metairie Louisiana, 70006, United States
New Orleans Louisiana, 70112, United States
Scarborough Maine, 04074, United States
Detroit Michigan, 48201, United States
Roseville Minnesota, 55113, United States
St. Louis Park Minnesota, 55416, United States
Columbia Missouri, 65201, United States
Columbia Missouri, 65201, United States
Kansas City Missouri, 64111, United States
Saint Louis Missouri, 63131, United States
Saint Louis Missouri, 63141, United States
St. Charles Missouri, 63301, United States
Voorhees New Jersey, 08043, United States
Albany New York, 12208, United States
Bronx New York, 10461, United States
Buffalo New York, 14263, United States
East Setauket New York, 11733, United States
Latham New York, 12110, United States
New York New York, 10011, United States
New York New York, 10016, United States
Rochester New York, 14623, United States
Stony Brook New York, 11790, United States
Valhalla New York, 10595, United States
Chapel Hill North Carolina, 27599, United States
Durham North Carolina, 27704, United States
Raleigh North Carolina, 27609, United States
Winston-Salem North Carolina, 27103, United States
Columbus Ohio, 43235, United States
Dayton Ohio, 45439, United States
Midwest City Oklahoma, 73310, United States
Tulsa Oklahoma, 74136, United States
Eugene Oregon, 97401, United States
Abington Pennsylvania, 19001, United States
Beaver Pennsylvania, 15009, United States
Philadelphia Pennsylvania, 19104, United States
Philadelphia Pennsylvania, 19107, United States
Philadelphia Pennsylvania, 19107, United States
Pittsburgh Pennsylvania, 15213, United States
Greenville South Carolina, 29605, United States
Chattanooga Tennessee, 37403, United States
Knoxville Tennessee, 37901, United States
Memphis Tennessee, 38117, United States
Memphis Tennessee, 38119, United States
Nashville Tennessee, 37205, United States
Nashville Tennessee, 37232, United States
Austin Texas, 78759, United States
Dallas Texas, 75230, United States
Dallas Texas, 75230, United States
Dallas Texas, 75235, United States
Dallas Texas, 75235, United States
Dallas Texas, 75246, United States
Fort Worth Texas, 76104, United States
Garland Texas, 75042, United States
McAllen Texas, 78503, United States
Mesqutie Texas, 75150, United States
San Antonio Texas, 78205, United States
San Antonio Texas, 78217, United States
Tyler Texas, 75702, United States
Salt Lake City Utah, 84112, United States
Fredericksburg Virginia, 22401, United States
Newport News Virginia, 23606, United States
Richmond Virginia, 23226, United States
Seattle Washington, 98111, United States
Seattle Washington, 98122, United States
Spokane Washington, 99202, United States
Vancouver Washington, 98664, United States
Madison Wisconsin, 53792, United States
Milwaukee Wisconsin, 53209, United States
Wausau Wisconsin, 54401, United States
Laramie Wyoming, 82070, United States
Calgary Alberta, T2N 4, Canada
Edmonton Alberta, T6G 2, Canada
Winnipeg Manitoba, R2H 2, Canada
Halifax Nova Scotia, B3H 1, Canada
Belleville Ontario, K8N 5, Canada
London Ontario, N6A 4, Canada
Peterborough Ontario, K9H 7, Canada
Toronto Ontario, M4N 3, Canada
Toronto Ontario, M5G 1, Canada
Toronto Ontario, M5G 2, Canada
Montreal Quebec, H4L 2, Canada
Rimouski Quebec, G5L 5, Canada
Saskatoon Saskatchewan, S7N 4, Canada
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