Fluorouracil and Leucovorin With or Without Irinotecan in Treating Patients Following Surgery for Stage III Colorectal Cancer

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

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.

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

Details

• Lead Sponsor: Pfizer
• Treatments: Calcium; Fluorouracil; Irinotecan; Leucovorin; Levoleucovorin

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed adenocarcinoma of the colon or intraperitoneal rectum

• Stage III

• Completely resected within the past 3-8 weeks

• No gross or microscopic evidence of residual disease after surgery

• No rectal cancer requiring total meso-rectal resection or pre- or postoperative radiotherapy

• No prior curatively resected synchronous metastasis of colorectal cancer

PATIENT CHARACTERISTICS:

Age:

• 18 to 75

Performance status:

• WHO 0-1

Life expectancy:

• Not specified

Hematopoietic:

• Absolute neutrophil count at least 2,000/mm^3

• Platelet count at least 150,000/mm^3

• Hemoglobin at least 10 g/dL

Hepatic:

• Bilirubin no greater than upper limit of normal (ULN)

• AST and ALT no greater than 2.5 times ULN

• Alkaline phosphatase no greater than 2.5 times ULN

Renal:

• Creatinine no greater than 1.5 mg/dL OR

• Creatinine clearance at least 60 mL/min

Cardiovascular:

• No myocardial infarction with the past year

• No uncontrolled hypertension

• No high-risk uncontrolled arrhythmia

• No unstable angina pectoris

Other:

• HIV negative

• No chronic diarrhea

• No current chronic inflammation or subobstruction of bowel after surgery

• No active uncontrolled infection

• No other prior or concurrent malignancy except curatively treated nonmelanoma skin cancer or carcinoma in situ of the cervix

• No psychological, social, familial, or geographical condition that would preclude follow-up

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception during and for 6 months after study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• No prior antineoplastic chemotherapy

Endocrine therapy:

• Not specified

Radiotherapy:

• See Disease Characteristics

Surgery:

• See Disease Characteristics

• No prior celioscopic resection of primary tumor

Other:

• At least 30 days since prior participation in another clinical trial with any investigational drug

• No other concurrent experimental drugs

• No other concurrent anticancer therapy