ABOUT THIS STUDY
1. Patient's age is 18 years or older, both genders.
2. Patients with metastatic disease who are eligible for first line FOLFOX chemotherapy. Adjuvant or neoadjuvant given at least 12 months prior for non-metastatic disease is permitted.
3. ECOG performance status ≤ 1
4. At least 4 weeks from prior major surgery or radiotherapy.
5. Life expectancy >3 months
6. Hematology: ANC ≥ 1.5X109/L; Platelets >100x109/L.
7. Adequate Renal function
8. Adequate Hepatic functions
9. Normal Cardiac function
1. Patients who had adjuvant or neoadjuvant therapy for non-metastatic disease given
within the last 12 months.
2. Patients who had received Oxaliplatin within 12 months prior to diagnosis of
3. Patients on concurrent anti cancer therapy other than that allowed in the study.
4. Patients on concurrent steroids, other than those allowed for routine antiemetics, or
5. Presence of clinically apparent or suspected brain metastasis.
6. Patients who have had myocardial infarction, severe congestive heart failure, or
significant arrhythmia within the past 6 months.
7. Serious active infection at the time of pre-study screening.
8. Active or history of autoimmune disorders/conditions.
9. Women who are pregnant or lactating
10. Concurrent active malignancy.
11. Ascites, pleural effusions, or osteoblastic bone metastases as the only site of
12. Other prior malignancies, except for cured or adequately treated malignancies for
which there has been no evidence of activity for more than 5 years.
13. Subjects with a condition which may interfere with the subjects' ability to understand
the requirements of the study.
14. Patients with history of life threatening allergic reactions to food or drugs
15. Patients with symptomatic peripheral neuropathy> Grade 1.
16. Known positive HIV, Hepatitis B surface antigen or Hepatitis C antibody.
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