FOLFOXIRI Compared With FOLFIRI for Metastatic Colorectal Cancer

• Status: Completed
• Trial end date: 2009-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to evaluate if the exposure to all the three active cytotoxic agents (FOLFOXIRI regimen) is superior in terms of response rate to conventional chemotherapy with the FOLFIRI regimen as first-line treatment of metastatic colorectal cancer patients.

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

Details

• Lead Sponsor: Gruppo Oncologico del Nord-Ovest
• Treatments: Camptothecin; Fluorouracil; Irinotecan; Leucovorin; Oxaliplatin

Criteria

Inclusion Criteria:

• adenocarcinoma of the colon or rectum

• unresectable metastatic disease

• age 18 to 75 years

• Eastern Cooperative Oncology Group (ECOG) performance status of 2 or lower if age 70 years or younger or ECOG performance status of 0 if age 71 to 75 years measurable disease according to WHOcriteria

• leukocyte count of at least 3,500/mm3, neutrophils count of at least 1,500/mm3, platelet count of at least 100,000/mm3

• serum creatinine of 1.3 mg/dL or less

• serum bilirubin less than 1.5 mg/dL and AST, ALT, and alkaline phosphatase 2.5 x normal values or less (
• previous fluoropyrimidine-based adjuvant chemotherapy was allowed if ended more than 6 months before random assignment

Exclusion Criteria:

• previous palliative chemotherapy for metastatic disease

• previous chemotherapy including irinotecan or oxaliplatin

• symptomatic cardiac disease, myocardial infarction in the last 24 months or uncontrolled arrhythmia

• active infections

• inflammatory bowel disease

• total colectomy