Combination Chemotherapy in Treating Patients With Stage III Colon Cancer

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

Summary

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 which chemotherapy regimen is more effective for stage III colon cancer. Randomized phase III trial to compare the effectiveness of fluorouracil plus leucovorin with or without irinotecan in treating patients who have undergone surgery for stage III colon cancer.

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

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Collaborators: Eastern Cooperative Oncology Group; NCIC Clinical Trials Group; North Central Cancer Treatment Group; Southwest Oncology Group
• Treatments: Calcium; Calcium, Dietary; Fluorouracil; Irinotecan; Leucovorin; Levoleucovorin

Criteria

Inclusion Criteria:

• Patients must have histologically documented adenocarcinoma of the colon; the gross inferior (caudad) margin of the primary tumor must lie above the peritoneal reflection; tumor must have been completely resected, including negative radial resecting margins

• There must be no history of distant metastatic disease at the time of registration

• Pathological evaluation must show Modified Astler-Coller stage C (TxN1-2M0) disease

• No previous or concurrent malignancy is allowed except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for five years

• Zubrod performance status of 0-2

• Non-pregnant and not nursing, as chemotherapy is thought to present substantial risk to the fetus/infant; men and women of reproductive potential may not participate unless they have agreed to use an effective contraceptive method while in this study

• Granulocytes >= 1,500/ul

• Platelet count >= 100,000/ul

• Creatinine =< 1.5 x upper limits of normal

• Bilirubin =< upper limit of normal