Combination Chemotherapy in Treating Patients With Colon Cancer

• Status: Unknown status
• 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. It is not yet known which schedule of chemotherapy is most effective in treating colon cancer.

PURPOSE: Randomized phase III trial to compare different schedules of chemotherapy using carboplatin with fluorouracil and leucovorin in treating patients who have stage IIB or stage III colon cancer.

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

Details

• Lead Sponsor: Groupe Regional d'Etudes du Cancer Colorectal
• Treatments: Calcium; Carboplatin; Fluorouracil; Leucovorin; Levoleucovorin

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed adenocarcinoma of the colon

• Stage IIB or III (Dukes stage B2 or C)

• Complete curative resection performed within the past 7 weeks (negative margins)

• No local or regional relapsed disease

• Tumor more than 15 cm above the anal margin

• Carcinoembryonic antigen less than 5 ng/mL (after surgery)

• No rectal cancer

• No metastatic disease

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• ECOG 0-1 OR

• Karnofsky 60-100%

Life expectancy

• Not specified

Hematopoietic

• Neutrophil count at least 2,000/mm3

• Platelet count at least 100,000/mm3

Hepatic

• Bilirubin no greater than 1.5 times upper limit of normal (ULN)

• SGOT and SGPT no greater than 5 times ULN

Renal

• Creatinine no greater than 1.5 times ULN

Cardiovascular

• No serious coronary disease

Other

• Not pregnant

• Fertile patients must use effective contraception

• No concurrent infectious disease

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

PRIOR CONCURRENT THERAPY:

Biologic therapy

• No prior immunotherapy

Chemotherapy

• No prior chemotherapy

Endocrine therapy

• Not specified

Radiotherapy

• No prior radiotherapy (before or after surgery)

Surgery

• See Disease Characteristics

Other

• No concurrent participation in another clinical trial