Combination Chemotherapy in Treating Patients With Colorectal Cancer and Resectable Metastases

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

PURPOSE: This randomized phase III trial is studying two different combination chemotherapy regimens to compare how well they work in treating patients with colorectal cancer and resectable metastases.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group; Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)
• Treatments: Fluorouracil; Folic Acid; Irinotecan; Leucovorin; Levoleucovorin; Oxaliplatin

Criteria

MAIN ELIGIBILITY CRITERIA

DISEASE CHARACTERISTICS:

• Histologically confirmed adenocarcinoma of the colon or rectum

• Resectable or resected metastatic disease,

PATIENT CHARACTERISTICS:

• WHO performance status 0-2

• Alkaline phosphatase ≤ 5 times upper limit of normal (ULN)

• Bilirubin ≤ 2 times normal

• Creatinine ≤ 135 mmol/L or creatinine clearance ≥ 60 mL/min

• SGOT and SGPT ≤ 3 times ULN

• No peripheral neuropathy that affects normal functions

• No unresolved complications from prior surgery

PRIOR CONCURRENT THERAPY:

• At least 1 year since prior FOLFOX 4 or FOLFIRI regimen in the adjuvant setting

• No concurrent participation in another clinical trial

• Recovered from prior therapy