Combination Chemotherapy With or Without Irinotecan in Treating Patients With Stage III Colon Cancer

• Status: Completed
• Trial end date: 2007-09-01
• 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 may kill more tumor cells. It is not yet known if combination chemotherapy is more effective with or without irinotecan in treating colon cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy with or without irinotecan in treating patients who have stage III colon cancer.

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

Details

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

Criteria

DISEASE CHARACTERISTICS:

• Histologically proven stage III adenocarcinoma of the colon that has been curatively resected within past 42 days

• No metastatic disease

• Node positive

• No more than 4 nodes affected (Tx, N2, M0) AND/OR

• N1 or N2 with perforation and/or occlusion

• No prior rectal cancer within 10 cm of anal margin or that was treated with preoperative radiotherapy

• No prior inflammatory disease of the intestine

PATIENT CHARACTERISTICS:

Age:

• 18 to 75

Performance status:

• Not specified

Life expectancy:

• Not specified

Hematopoietic:

• Neutrophil count at least 2,000/mm3

• Platelet count at least 100,000/mm3

Hepatic:

• Bilirubin less than 1.25 times upper limit of normal (ULN)

• SGOT and SGPT less than 3 times ULN

• Alkaline phosphatase less than 3 times ULN

Renal:

• Not specified

Cardiovascular:

• No myocardial infarction within past 6 months

• No insufficient cardiac function

Other:

• No other serious medical illness

• No active infection

• No other malignancy except skin cancer or carcinoma in situ of the cervix

• No psychological or social condition that would preclude study

• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• Not specified

Endocrine therapy:

• Not specified

Radiotherapy:

• See Disease Characteristics

Surgery:

• See Disease Characteristics

• No prior extensive intestinal resection