TREE-2: Three Regimens of Eloxatin in Advanced Colorectal Cancer

Exclusion Criteria

• •The presence of any of the following will exclude a subject from study enrollment:
• •1. Prior treatment with oxaliplatin or bevacizumab.
• •2. Any uncontrolled infection.
• •3. History of myocardial infarction within the previous 6 months or current clinical evidence of congestive heart failure, non-stable coronary artery disease, clinically significant hypertension (blood pressure of \>160/110 mmHg on medication), or symptomatic peripheral vascular disease.
• •4. History of any other cancer (except non melanoma skin cancer or carcinoma in-situ of the cervix) unless in complete remission and off all therapy for that cancer for at least 5 years.
• •5. Central nervous system metastases.
• •6. Peripheral neuropathy of any cause.
• •7. Pregnant or lactating women.
• •8. Hypersensitivity to one of the study drugs or ingredients.
• •9. Participation in any investigational drug study within 4 weeks preceding enrollment.
• •10. Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome.
• •11. Medical or psychiatric disorders that would interfere with informed consent, compliance or make them a poor risk for participation in this trial.
• •12. Patients with known DPD deficiency.
• •13. Patients with interstitial pneumonia or extensive symptomatic fibrosis of the lungs.
• •14. Patients with calculated creatinine clearance of \<30 ml/min using Cockroft and Gault formula.
• •15. Patients who have received an organ allograft.
• •16. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study entry.
• •17. Chronic, daily treatment with aspirin (\>325 mg/day) or nonsteroidal anti-inflammatory medications (intermittent or "p.r.n." use for pain is permitted).
• •18. Evidence of a bleeding diathesis or coagulopathy.
• •19. Subjects found to have proteinuria at baseline - If patients are found to have \>/= 1+ proteinuria at baseline screening they should undergo a 24-hour urine collection, which must be an adequate collection and must demonstrate \<2g of protein/24 hr to allow participation in the study.
• •20. Patients on chronic therapeutic Warfarin therapy.