Combination Chemotherapy in Treating Patients With Advanced Colorectal Cancer

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed locally advanced, locally recurrent, or metastatic colorectal adenocarcinoma not curable by surgery or radiotherapy

  • Histological or cytological requirement waived in patients who developed radiological or clinical evidence of metastatic cancer after a prior surgical resection unless:

    • More than 5 years has elapsed since primary surgery OR
    • Primary cancer was stage I or II
• Site of primary lesion must be or have been confirmed endoscopically, radiologically, or surgically to be or have been in the large bowel
• Measurable or evaluable disease
• No CNS metastases or carcinomatous meningitis

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• ECOG 0-2

Life expectancy:

• At least 12 weeks

Hematopoietic:

• Absolute granulocyte count at least 1,500/mm^3
• Platelet count at least 100,000/mm^3
• Hemoglobin at least 9.0 g/dL (transfusion allowed)

Hepatic:

• Bilirubin no greater than 1.5 mg/dL
• AST no greater than 5 times upper limit of normal (ULN)
• Alkaline phosphatase no greater than 5 times ULN

Renal:

• Creatinine no greater than 1.5 times ULN

Cardiovascular:

• No uncontrolled hypertension
• No unstable angina
• No symptomatic congestive heart failure
• No myocardial infarction within the past 6 months
• No serious uncontrolled arrhythmia
• No New York Heart Association class III or IV cardiac disease

Pulmonary:

• No interstitial pneumonia or extensive and symptomatic interstitial fibrosis of the lung
• No pleural effusion or ascites that cause respiratory compromise (grade 2 or worse dyspnea)

Other:

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No active or uncontrolled infection
• No symptomatic sensory peripheral neuropathy
• No known allergy to platinum compounds
• No history of gastrointestinal bleeding unless it is determined to be acceptable by the enrolling physician
• No other prior or concurrent malignancy within the past 3 years except nonmelanoma skin cancer, carcinoma in situ of the uterine cervix, or other resected malignant tumor with less than a 10% probability of tumor relapse within 3 years of diagnosis
• No medical or psychiatric conditions that would preclude study
• No colonic or small bowel disorders with uncontrolled symptoms of more than 3 loose stools per day
• Colostomy or ileostomy allowed at investigator's discretion

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Prior adjuvant immunotherapy for resected stage II-IV disease allowed if adjuvant therapy concluded at least 1 year before documentation of recurrent disease
• No concurrent sargramostim (GM-CSF)

Chemotherapy:

• No prior chemotherapy for advanced colorectal cancer
• No prior standard adjuvant chemotherapy for rectal cancer
• Prior adjuvant fluorouracil for resected stage II-IV disease allowed if adjuvant therapy concluded at least 1 year before documentation of recurrent disease

Radiotherapy:

• See Disease Characteristics
• At least 4 weeks since prior major radiotherapy (e.g., chest or bone palliative radiotherapy)
• No prior radiotherapy to more than 15% of bone marrow
• No prior standard adjuvant radiotherapy for rectal cancer

Surgery:

• See Disease Characteristics
• At least 4 weeks since prior major surgery (e.g., laparotomy) (2 weeks for minor surgery) and recovered
• Insertion of a vascular access device not considered major or minor surgery

Other:

• No other concurrent investigational agents