Fluorouracil and Irinotecan With or Without Leucovorin Compared With Observation in Treating Patients Who Have Undergone Surgery for Stage II Colon Cancer

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

Summary

RATIONALE: Drugs used in chemotherapy, such as irinotecan, leucovorin, and fluorouracil, work in 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 any remaining tumor cells. It is not yet known whether combination chemotherapy is more effective than observation alone in treating patients who have undergone surgery for colon cancer.

PURPOSE: This randomized phase III trial is studying irinotecan and fluorouracil with or without leucovorin to see how well they work compared to observation alone in treating patients who have undergone surgery for stage II colon cancer.

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

Details

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

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed adenocarcinoma of the colon

• Stage II disease (pT3, N0 or pT4, N0)

• Penetration of the subserosa or serosa

• No lymph node metastases

• At least 12 lymph nodes analyzed

• More than 1 synchronous primary colon tumor allowed

• Staging determined for the more advanced tumor

• Curative radical resection within the past 2-8 weeks required

• Proximal, distal, and radical margins must be free of tumor (R0 resection)

• No rectal tumors

• Gross distal margin of the primary tumor must lie above the peritoneal reflection

• No known familial adenomatous polyposis

• No hereditary nonpolyposis colorectal cancer

• No distant metastases

PATIENT CHARACTERISTICS:

Age

• 18 to 75

Performance status

• WHO 0-1

Life expectancy

• Not specified

Hematopoietic

• Granulocyte count ≥ 2,000/mm^3

• Platelet count ≥ 100,000mm^3

• Hemoglobin ≥ 10 g/dL

Hepatic

• Bilirubin < 1.25 times upper limit of normal (ULN)

• No known Gilbert's syndrome

Renal

• Creatinine < 1.25 times ULN

Cardiovascular

• No severe or uncontrolled coronary disease

• No severe heart failure

• No uncontrolled arterial hypertension

• No myocardial infarction within the past year

• No cerebral vascular accident within the past year

• Cardiac arrhythmia allowed provided patient is on proper anticoagulation therapy* NOTE: *Aspirin is not considered proper anticoagulation

Gastrointestinal

• No Gardner's syndrome

• No Turcot's syndrome

• No Crohn's disease

• No ulcerative colitis

Other

• No other prior malignancy except adequately treated basal cell skin cancer or carcinoma in situ of the cervix

• No other serious disease

• No contraindication to any study drugs

• No known allergy to leucovorin calcium

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception during and for up to 6 months after study treatment

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• No prior chemotherapy

Endocrine therapy

• Not specified

Radiotherapy

• No prior radiotherapy

Surgery

• See Disease Characteristics

Other

• No other concurrent anticancer therapy

• No concurrent vitamin supplements containing folic acid