Inclusion Criteria

MAIN ELIGIBILITY CRITERIA

- Histologically proven metastatic adenocarcinoma of colon or rectum

- Documented inoperable disease (i.e., not suitable for complete carcinological
surgical resection)

- Measurable lesion as assessed by CT scan or MRI in at least one dimension (longest
diameter to be recorded) ≥ 20 mm with conventional CT scan or ≥ 10 mm with spiral CT
scan

- No previous therapy for metastatic disease

- No history or evidence upon physical examination of CNS disease (e.g., non-irradiated
CNS metastasis, seizure not controlled with standard medical therapy, or history of
stroke) unless adequately treated

- No exclusive bone metastasis

- ECOG performance status 0-2

- WBC ≥ 1,500/mm^3

- Platelets ≥ 100,000/mm^3

- Hemoglobin > 9 g/dL (may be transfused to maintain or exceed this level)

- Proteinuria < 2+ by dipstick OR ≤ 1 g of protein on 24-hr urine collection

- Bilirubin < 1.5 times ULN

- Alkaline phosphatase < 3 times ULN

- No peripheral sensory neuropathy

- Negative pregnancy test

- Fertile patients must use effective means of contraception (oral contraceptives,
intrauterine contraceptive device, barrier method of contraception in conjunction
with spermicidal jelly, or surgically sterilization)

- No peripheral neuropathy ≥ grade 1

- No clinically significant (i.e. active) cardiovascular disease

- No evidence of bleeding diathesis or coagulopathy

- No serious, non-healing wound, ulcer, or bone fracture

- No significant ophthalmologic abnormality

- More than 28 days since prior major surgical procedure or open biopsy