OBJECTIVES:

• Compare the efficacy of fluorouracil and leucovorin calcium with or without oxaliplatin in prolonging disease-free survival and overall survival in patients with stage II or III carcinoma of the colon.

OUTLINE: This is a randomized study. Patients are randomized to one of two treatment arms.

• Arm I: Patients receive leucovorin calcium IV over 2 hours and fluorouracil IV (administered after 1 hour of leucovorin calcium) weekly for 6 weeks.
• Arm II: Patients receive oxaliplatin IV over 2 hours on days 1, 15, and 29 and leucovorin calcium and fluorouracil as in arm I.

Treatment in both arms repeats every 8 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed at 6, 9, and 12 months; every 6 months for 4 years; and then annually thereafter.

PROJECTED ACCRUAL: A total of 2,472 patients will be accrued for this study within 3 years.

DISEASE CHARACTERISTICS:

• Previously resected potentially curable stage II or III carcinoma of the colon (T3,4; N0,1,2; M0)
• Distal extent of tumor(s) at least 12 cm from anal verge on endoscopy
• No tumors demonstrating free perforation as manifested by free air or fluid in the abdomen (walled off perforations allowed)
• Adjacent structures (e.g., bladder, small intestine, ovary) involved with primary tumor must have been curatively resected
• No prior or concurrent colon tumors other than carcinoma (sarcoma, lymphoma, carcinoid)
• No prior invasive colon or rectal malignancy
• No primary tumors involving both colon and rectum
• No isolated, distant, or noncontiguous intraabdominal metastases, even if resected
• Intestinal obstruction allowed

PATIENT CHARACTERISTICS:

Age:

• Any age

Performance status:

• ECOG 0-2

Life expectancy:

• At least 10 years (excluding cancer)

Hematopoietic:

• Granulocyte count at least 1,500/mm^3
• Platelet count at least 100,000/mm^3

Hepatic:

• Bilirubin normal
• Alkaline phosphatase normal
• SGOT/SGPT normal

Renal:

• Creatinine normal

Cardiovascular:

• No active ischemic heart disease (New York Heart Association class III-IV)
• No myocardial infarction within the past 6 months
• No concurrent symptomatic arrhythmia

Other:

• No other malignancy within the past 5 years except curatively treated squamous cell or basal cell skin cancer, carcinoma in situ of the cervix treated by resection only, or lobular carcinoma in situ of the breast
• Not pregnant or nursing
• Fertile patients must use effective contraception
• No nonmalignant systemic disease that would preclude study entry
• No grade 2 or greater peripheral neuropathy
• No psychiatric or addictive disorder that would preclude informed consent

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• No concurrent biologic response modifiers

Chemotherapy:

• No prior chemotherapy
• No other concurrent chemotherapy

Endocrine therapy:

• Not specified

Radiotherapy:

• No prior radiotherapy for this malignancy
• No concurrent radiotherapy for this malignancy

Surgery:

• See Disease Characteristics
• No more than 42 days since prior curative resection
• No prior noncurative surgical resection for this malignancy, except colostomy
• No prior laparoscopically assisted colectomy (unless participating in Intergroup Protocol INT 0146 or the Australasian ALCCaS protocol)

Other:

• No other concurrent investigational drugs
• No concurrent halogenated antiviral agents (e.g., sorivudine)