A Randomized, Prospective Study Comparing Three Regimens Of Eloxatin ™ Plus Fluoropyrimidine For Evaluation Of Safety And Tolerability In First Line Treatment Of Patients With Advanced Colorectal Cancer (Tree Study)

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically confirmed adenocarcinoma of the colon or rectum

- Metastatic or recurrent disease not amenable to potentially curative treatment

- At least 1 unidimensionally measurable lesion at least 20 mm by conventional
techniques OR at least 10 mm by spiral CT scan

- Histological or cytological confirmation is required for a solitary target
lesion

- No CNS metastases

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- ECOG 0-1

Life expectancy

- Not specified

Hematopoietic

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

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

Hepatic

- Bilirubin no greater than 2 times upper limit of normal (ULN)

- SGPT and SGOT no greater than 3 times ULN

Renal

- Creatinine no greater than 1.5 times ULN

- Creatinine clearance at least 30 mL/min

Cardiovascular

- No myocardial infarction within the past 6 months

- No clinical evidence of congestive heart failure

- No unstable coronary artery disease

Pulmonary

- No interstitial pneumonia

- No extensive symptomatic fibrosis of the lungs

Gastrointestinal

- Able to tolerate oral medication

- No lack of physical integrity of the upper gastrointestinal tract

- No malabsorption syndrome

- No swallowing difficulties

Other

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for 6 months after study
participation

- No other concurrent serious illness

- No uncontrolled infection

- No other concurrent malignancy except nonmelanoma skin cancer or carcinoma in situ of
the cervix or any other cancer for which the patient has been off all therapy and in
remission for at least 5 years

- No peripheral neuropathy

- No hypersensitivity to any of the study drugs or their ingredients

- No known dihydropyrimidine dehydrogenase deficiency

- No other medical or psychiatric disorder that would preclude giving informed consent
or complying with study

PRIOR CONCURRENT THERAPY:

Biologic therapy

- No concurrent prophylactic hematopoietic growth factor therapy

- No prior bevacizumab (Avastin™)

Chemotherapy

- At least 6 months since prior adjuvant fluorouracil, leucovorin calcium, and
irinotecan

- No prior oxaliplatin

- No prior chemotherapy for metastatic or recurrent disease

- No other concurrent chemotherapy

Endocrine therapy

- Not specified

Radiotherapy

- No concurrent radiotherapy unless for the control of bone pain

Surgery

- Recovered from prior surgery

- No prior organ allografts

Other

- More than 4 weeks since prior investigational drugs

- No concurrent iced mouth rinses for the prevention of stomatitis

- No concurrent cold cap alopecia prevention

- No concurrent pyridoxine

- No concurrent sorivudine or chemically-related analogues (e.g., brivudine)

- No concurrent chronic aspirin, nonsteroidal anti-inflammatory drugs, or warfarin