Trial Information

CPT-11 in Combination With Weekly 24 Hour Infusion 5-FU Plus Folinic Acid Relative to Weekly 24 Hour Infusion 5-FU Plus Folinic Acid Alone in Patients With Advanced Colorectal Cancer

OBJECTIVES: I. Compare the efficacy and toxicity of high-dose fluorouracil and leucovorin
calcium with or without irinotecan in patients with metastatic adenocarcinoma of the colon
or rectum. II. Compare progression-free survival, overall survival, response rate, and
duration of response in patients treated with these 2 regimens. III. Compare quality of life
of patients treated with these 2 regimens.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to one of two
treatment arms. Arm I: Patients receive leucovorin calcium IV over 2 hours followed by
fluorouracil IV over 24 hours on days 1, 8, 15, 22, 29, and 36. Arm II: Patients receive
irinotecan IV over 30 minutes followed by leucovorin calcium IV over 2 hours and
fluorouracil IV over 24 hours on days 1, 8, 15, 22, 29, and 36. Treatment in both arms
repeats every 7 weeks in the absence of disease progression or unacceptable toxicity.
Patients in arm I who develop disease progression begin second-line therapy comprising
irinotecan, fluorouracil, and leucovorin calcium within 2 months of progression. Patients
with complete response are taken off study after receiving treatment for one year. Quality
of life is assessed before beginning study, after completion of each course, at 4 weeks
after completion of study, and then every 2 months until disease progression or death.
Patients are followed every 2 months until disease progression or death.

PROJECTED ACCRUAL: A total of 430 patients (215 per arm) will be accrued for this study
within 2 years.