Combination Chemotherapy as First-Line Therapy in Treating Older Patients With Metastatic Colorectal Cancer That Cannot Be Removed By Surgery

• Status: Completed
• Trial end date: 2011-01-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy, such as fluorouracil, leucovorin, and irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) in different doses or combinations may kill more tumor cells. It is not yet known which combination chemotherapy regimen is more effective in treating colorectal cancer.

PURPOSE: This randomized clinical trial is studying how well fluorouracil works together with leucovorin with or without irinotecan in treating older patients with metastatic colorectal cancer .

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

Details

• Lead Sponsor: Federation Francophone de Cancerologie Digestive
• Treatments: Calcium; Calcium, Dietary; Camptothecin; Fluorouracil; Irinotecan; Leucovorin; Levoleucovorin

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed adenocarcinoma of the colon or rectum

• Metastatic disease

• Unresectable disease

• Measurable disease that is outside the field of prior irradiation

• No brain metastases

PATIENT CHARACTERISTICS:

• Karnofsky performance status 60-100%

• Absolute neutrophil count ≥ 1,500/mm^3

• Platelet count ≥ 100,000/mm^3

• Transaminases ≤ 5 times normal

• Bilirubin ≤ 1.5 times normal

• Alkaline phosphatase < 3 times normal (5 times normal if due to hepatic involvement)

• Creatinine clearance > 45 mL/min

• Life expectancy > 3 months

• No psychological, social, or geographical situation that would preclude study treatment

• No chronic diarrhea or enteropathy

• No coronary insufficiency or symptomatic cardiac disease

• No other malignancy unless curatively treated

• No contraindication to chemotherapy

PRIOR CONCURRENT THERAPY:

• At least 6 months since prior adjuvant chemotherapy for the primary tumor

• No prior extensive resection

• No other concurrent anticancer therapy