Colorectal Cancer Clinical Trial
Official title:
Alternation of FOLFOX6 (Oxaliplatin - Leucovorin - Fluorouracil) and FOLFIRI (Irinotecan - Leucovorin - Fluorouracil) as Second Line Treatment of Metastatic Colorectal Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating
patients who have metastatic colorectal cancer that has not responded to previous
chemotherapy.
OBJECTIVES: I. Determine the efficacy of oxaliplatin, leucovorin calcium, and fluorouracil
followed by irinotecan, leucovorin calcium, and fluorouracil in terms of progression free
survival in patients with metastatic colorectal cancer. II. Evaluate these treatment
regimens in terms of overall survival, response rate, toxicity, and quality of life in this
patient population.
OUTLINE: This is a multicenter study. Patients receive 4 courses of oxaliplatin IV and
leucovorin calcium IV over 2 hours on day 1 followed by fluorouracil IV continuously over 46
hours. Following the initial 4 courses of therapy, patients receive 4 courses of irinotecan
IV over 30-90 minutes and leucovorin calcium IV over 2 hours on day 1 followed by
fluorouracil IV continuously over 46 hours. Courses repeat every 2 weeks in the absence of
disease progression or unacceptable toxicity. Quality of life is assessed every 8 weeks.
Patients are followed every 3 months until death.
PROJECTED ACCRUAL: A total of 14-39 patients will be accrued for this study over 12 months.
;
Primary Purpose: Treatment
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