Oxaliplatin (NSC 266046) in Combination With 5-Fluorouracil and Leucovorin (FOLFOX4) for Patients Who Have Not Received Prior Chemotherapy for Advanced Colorectal Cancer

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Must not be eligible for Inter-group, Cooperative Group, or local clinical trials of
higher priority

- Histologically or cytologically confirmed colorectal adenocarcinoma

- Locally advanced or metastatic

- Not curable by surgery or amenable to radiation therapy with curative intent

- Site of primary lesion must be or have been in the large bowel, as confirmed
endoscopically, radiologically, or surgically

- No separate histological or cytological confirmation of metastatic disease is
required for patients with a history of colorectal cancer treated by surgical
resection who develop radiological or clinical evidence of metastatic cancer unless:

- More than 5 years has elapsed since prior primary surgery and the development of
metastatic disease OR

- Primary cancer was a Duke's A or B1 lesion

- Measurable or evaluable disease

- No prior chemotherapy for advanced colorectal cancer

- Prior adjuvant therapy allowed for resected stage II, III, or IV disease with
any regimen containing fluorouracil with or without irinotecan or with
immunotherapy, provided recurrent disease has been documented

PATIENT CHARACTERISTICS:

Age:

- 15 and over

Performance status:

- ECOG 0-2 OR

- Karnofsky 60-100%

Life expectancy:

- Not specified

Hematopoietic:

- Absolute granulocyte count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3

- Hemoglobin at least 9 g/dL (transfusion allowed)

Hepatic:

- Bilirubin no greater than 1.5 mg/dL (regardless of liver involvement secondary to
tumor)

- AST less than 5 times upper limit of normal (ULN)

- Alkaline phosphatase less than 5 times ULN

Renal:

- Creatinine no greater than 1.5 times ULN

Cardiovascular:

- No uncontrolled high blood pressure

- No symptomatic congestive heart failure

- No unstable angina pectoris

- No cardiac arrhythmia

- No myocardial infarction within the past 6 months

- No New York Heart Association class III-IV cardiac disease

Pulmonary:

- No interstitial pneumonia or extensive and symptomatic interstitial fibrosis of the
lung

- No pleural effusion or ascites that causes respiratory compromise (i.e., dyspnea
grade 2 or greater)

Other:

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No history of allergic reactions to compounds of similar chemical or biologic
composition to platinum agents or oxaliplatin as well as other study agents

- No neuropathy grade 2 or greater, regardless of causality

- No HIV-positive patients receiving combination anti-retroviral therapy

- No ongoing or active infection

- No uncontrolled concurrent illness

- No psychiatric or social situations that would preclude study compliance

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- See Disease Characteristics

- No concurrent sargramostim

Chemotherapy:

- See Disease Characteristics

Endocrine therapy:

- Not specified

Radiotherapy:

- See Disease Characteristics

- At least 4 weeks since prior major radiotherapy (e.g., chest or bone palliative
radiotherapy)

Surgery:

- See Disease Characteristics

- At least 4 weeks since prior major surgery (e.g., laparotomy)

- At least 2 weeks since prior minor surgery

- Insertion of a vascular access device is not considered major or minor surgery

Other:

- Recovered from effects of prior treatment

- No other concurrent investigational agents

- No oral cryotherapy on day 1 of each course