Randomized Phase II Study Evaluating Three Chemotherapies: [Irinotecan + Oxaliplatin (Irinox)], [Irinotecan + LV5FU2] and [Oxaliplatin + LV5FU2] as First Intention Treatment in Subjects With Metastatic Colorectal Cancer
OBJECTIVES:
- Compare the efficacy, in terms of response rate (partial response and complete
response), of irinotecan and oxaliplatin vs irinotecan, fluorouracil, and leucovorin
calcium vs oxaliplatin, fluorouracil, and leucovorin calcium in patients with
metastatic colorectal cancer.
- Compare the progression-free survival of patients treated with these regimens.
- Compare the tolerability of these regimens in these patients.
- Compare the quality of life of patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 3
treatment arms.
- Arm I: Patients receive irinotecan IV over 90 minutes and oxaliplatin IV over 2 hours
on day 1.
- Arm II: Patients receive irinotecan IV over 90 minutes and leucovorin calcium IV over 2
hours on day 1 and fluorouracil IV over 46 hours on days 1-2.
- Arm III: Patients receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2
hours on day 1 and fluorouracil IV over 46 hours on days 1-2.
In all arms, treatment repeats every 2 weeks for 26 courses in the absence of disease
progression or unacceptable toxicity.
Quality of life is assessed at baseline and then every 3 months for 1 year.
Patients are followed at 2 months.
PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study within 1 year.
Interventional
Allocation: Randomized, Primary Purpose: Treatment
Yves Becouarn, MD
Study Chair
Institut BergoniƩ
United States: Federal Government
CDR0000315384
NCT00066274
May 2002
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