A Randomized Phase III Equivalence Trial of Irinotecan (CPT-11) Versus Oxaliplatin (OXAL)/5-Fluorouracil (5-FU)/Leucovorin (CF) in Patients With Advanced Colorectal Carcinoma Previously Treated With 5-FU
I. Determine whether in advanced colorectal carcinoma patients who have been previously
treated with 5-FU, the overall survival of patients treated with OXAL + 5-FU + CF followed
by CPT-11 is equivalent to the survival of patients treated with CPT-11 followed by OXAL +
5-FU + CF.
I. Evaluation of time to tumor progression, time to treatment failure, toxicity of
treatment, and overall response rate in patients treated with these two regimens.
II. To compare quality-of-life measurements patients treated with these two regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
performance status (ECOG 0-1 vs 2), primary indicator lesion (hepatic vs pulmonary vs
other), age (less than 65 vs at least 65 years), alkaline phosphatase (less than 2 vs at
least 2 times ULN), fluorouracil failure (adjuvant vs metastatic), and membership
(intergroup vs expanded participation project). Patients are randomized to one of two
ARM I: Patients receive irinotecan IV over 90 minutes on day 1. Treatment repeats every 3
weeks in the absence of disease progression or unacceptable toxicity.
ARM II: Patients receive oxaliplatin IV over 2 hours on day 1, leucovorin calcium IV over 2
hours on days 1 and 2, and fluorouracil IV bolus followed by IV infusion over 22 hours on
days 1 and 2. Treatment repeats every 2 weeks in the absence of disease progression or
Patients who experience progression or toxicity on the initial regimen may crossover to the
other regimen. At least 3 weeks must elapse between regimens.
Quality of life is assessed at baseline, prior to each chemotherapy course, at crossover,
and at the end of the study.
Patients are followed every 6 months for 3 years or until death.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
The primary analysis for this trial will be based on a one-sided Generalized Wilcoxon test.
At least 6 months
North Central Cancer Treatment Group
United States: Food and Drug Administration
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