text: Irinotecan or Fluorouracil Plus Leucovorin in Treating Patients With Previously Treated Metastatic Colorectal Cancer
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  RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving the drugs in different combinations may kill more tumor cells.
  PURPOSE: Phase II trial to compare the effectiveness of either irinotecan or fluorouracil plus leucovorin in treating patients who have metastatic colorectal cancer that has been previously treated with oxaliplatin with or without irinotecan.
  - Determine the tumor response rate in patients receiving irinotecan or fluorouracil and leucovorin calcium for metastatic colorectal cancer previously treated with oxaliplatin with or without irinotecan.
  - Determine the time to tumor progression, time to treatment failure, and overall survival of patients treated with these regimens.
  - Determine the toxic effects of these regimens in these patients.
  - Evaluate the quality of life of patients treated with these regimens.
  OUTLINE: This is a multicenter study. Patients are stratified according to prior chemotherapy (oxaliplatin-based therapy vs irinotecan and oxaliplatin combination therapy). Patients are assigned to one of two treatment groups.
  - Group I (prior oxaliplatin-based chemotherapy): Patients receive irinotecan IV over 90 minutes on day 1. Treatment repeats every 3 weeks.
  - Group II (prior irinotecan and oxaliplatin combination chemotherapy): Patients receive leucovorin calcium IV over 2 hours and fluorouracil IV continuously on days 1 and 2. Treatment repeats every 2 weeks.
  - Both groups: Treatment continues in the absence of disease progression or unacceptable toxicity. Patients with a confirmed complete response for 2 consecutive courses may discontinue treatment at investigator's discretion.
  Quality of life is assessed at baseline, approximately every 6 weeks during treatment, and then after the last course of treatment.
  PROJECTED ACCRUAL: A total of 40-96 patients (20-48 per arm) will be accrued for this study within 1-2 years.
  Allocation: Non-Randomized, Control: Active Control, Primary Purpose: Treatment
  fluorouracil, irinotecan hydrochloride, leucovorin calcium
  85259-5404
  Source: http://clinicaltrials.gov/show/NCT00016952
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