Fluorouracil and Leucovorin With or Without Irinotecan in Treating Patients Following Surgery for Stage III Colorectal Cancer
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      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 and giving them after surgery may kill
      more tumor cells.

      PURPOSE: Randomized phase III trial to compare the effectiveness of fluorouracil and
      leucovorin with or without irinotecan in treating patients who have undergone surgery for
      stage III colorectal cancer.
    

Detailed description: 
      OBJECTIVES:

        -  Compare the disease-free survival at 3 years of patients with resected stage III
           colorectal cancer treated with adjuvant fluorouracil and leucovorin calcium with or
           without irinotecan.

        -  Compare the disease-free and overall survival at 5 years of patients treated with these
           regimens.

        -  Compare the safety profiles of these treatment regimens in these patients.

        -  Compare the quality-adjusted survival of patients treated with these regimens.

        -  Correlate the expression of putative prognostic markers (thymidylate synthase,
           telomerase, topoisomerase) with disease-free and overall survival of patients treated
           with these regimens.

      OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified
      according to participating center. Patients are randomized to 1 of 2 treatment arms.

      Arm I

        -  Patients receive irinotecan IV over 30-90 minutes, leucovorin calcium IV over 2 hours,
           and fluorouracil IV over 24 hours weekly for 6 weeks. Courses repeat every 7 weeks for
           up to 4 courses in the absence of disease progression or unacceptable toxicity.

        -  As an alternative schedule, patients may receive irinotecan IV over 30-90 minutes and
           day 1 and leucovorin calcium IV over 2 hours and fluorouracil IV over 22 hours on days 1
           and 2 every 2 weeks for 6 weeks. Treatment repeats every 6 weeks for up to 4 courses in
           the absence of disease progression or unacceptable toxicity.

      Arm II

        -  Patients receive leucovorin calcium and fluorouracil as in arm I. Quality of life may be
           assessed at baseline; prior to courses 2, 3, and 4; and at 1, 3, and 6 months.

      Patients are followed every 3 months for 3 years and then every 6 months for 2 years.

      PROJECTED ACCRUAL: Approximately 1800 patients (900 per arm) will be accrued for this study
      within 24 months.
    

Intervention name(s): FOLFIRI regimen; fluorouracil; irinotecan hydrochloride; leucovorin calcium
Intervention type(s): Drug; Drug; Drug; Drug
Intervention MeSH terms: Leucovorin; Fluorouracil; Irinotecan; Calcium; Levoleucovorin
Allocation: Randomized
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage III colon cancer; stage III rectal cancer; adenocarcinoma of the colon; adenocarcinoma of the rectum