1. NSABP Protocol C-08
Ming He MD

2. Stage II or III resected colon cancer
NSABP C-08
Randomize
Oxaliplatinum
Leucovorin
5-FU
Repeat every 2 weeks x 6 months
Bevacizumab on Day 1 of every chemotherapy cycle, then continued every 2 weeks for a total of 1 year
Oxaliplatinum
Leucovorin
5-FU
Repeat every 2 weeks x 6 months

3. Prognostic Factors in Stage II Colon Cancer
Obstructing tumor
Perforated tumor
Lymphatic or vascular invasion
Poorly differentiated histology

4. NSABP C-08: Group A 14-day cycle 46-hour infusion
5-fluorouracil 400 mg/m2
5-fluorouracil 2400 mg/m2
Oxaliplatinum 85 mg/m2 + Leucovorin 400 mg/m2

5. NSABP C-08: Group B 14-day cycle 46-hour infusion
5-fluorouracil 400 mg/m2
5-fluorouracil 2400 mg/m2
Oxaliplatinum 85 mg/m2 + Leucovorin 400 mg/m2
Bevacizumab 5 mg/kg

6. Selected Adverse Events in Relation to Bevcizumab
Table 4. Selected Adverse Events.
Hurwitz, H. et al. N Engl J Med 2004;350:

7. Adverse Events in Relation to Bevacizumab
Increased risk of post operative bleeding and wound healing complications while receiving Bevacizumab
Immediate and long term effect on fertility and pregnancy unknown
Teratogenic in animal studies

8. Patient Eligibility
Randomization occurs beginning post operative Day 29 and ending post operative Day 50
Adenocarcinoma
En bloc curative resection
Distal extent of tumor must be at least 12cm from anal verge
Blood pressure of less than or equal to 150/90

9. Exclusions Significant bleeding within 6 months Non healing wound
Active GI ulcers
Surgery, open biopsy, trauma within 28 days
Minor procedure within 7 days
Any previous CNS ischemia
Peripheral or visceral arterial ischemia within 6 months