Phase II Trial Of Irinotecan + 5-Fluorouracil + Leucovorin + Oxaliplatin As First-Line Treatment For Metastatic Colorectal Cancer

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Diagnosis of colorectal adenocarcinoma

- Metastatic disease

- Not curable by surgery or amenable to radiotherapy with curative intent

- Measurable disease

- Patients with only lesions measuring ≥ 1 cm but < 2 cm must use spiral CT scan
for pre- and post-treatment tumor assessments

- No known CNS metastases or carcinomatous meningitis

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- ECOG 0-2

Life expectancy

- At least 12 weeks

Hematopoietic

- Absolute neutrophil count ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

Hepatic

- AST ≤ 5 times upper limit of normal (ULN)

- Bilirubin ≤ 0.5 mg/dL above ULN

Renal

- Creatinine ≤ 1.5 times ULN OR

- Creatinine clearance ≥ 60 mL/min

Cardiovascular

- No unstable angina

- No symptomatic congestive heart failure

- No serious uncontrolled cardiac arrhythmia

Pulmonary

- No prior clinical diagnosis of interstitial lung disease

Other

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No active or uncontrolled infection

- No other concurrent serious illness

- No pre-existing paraesthesias/dysesthesias of ≥ grade 2 that would interfere with
function

- No other malignancy within the past 5 years except adequately treated basal cell or
squamous cell skin cancer or adequately treated noninvasive carcinomas

PRIOR CONCURRENT THERAPY:

Biologic therapy

- No concurrent sargramostim (GM-CSF)

Chemotherapy

- At least 6 months since prior adjuvant chemotherapy

- No prior fluorouracil for advanced colorectal cancer

- No prior adjuvant oxaliplatin

- No prior adjuvant irinotecan

Endocrine therapy

- Not specified

Radiotherapy

- No prior radiotherapy to > 25% of bone marrow

Surgery

- At least 4 weeks since prior major surgery