ECOG 5202

Principal Investigator:	Peter Kozuch, MD
Time frame of study:	Ongoing
Location of Study:	Beth Israel Medical Center St.Luke's-Roosevelt Hospital Center
Contact:	Continuum Cancer Research Program (212) 844-6286

Summary:
New information about the biology of colon cancer cells may make it possible to identify stage II colon cancer patients at high risk of developing recurrence of their cancer and to more clearly define the low-risk group that would not require chemotherapy after surgery. The purpose of this Phase III trial is to determine if certain molecular observations identified in some colon cancer cells may be used to accurately identify patients who are low-risk and would not require chemotherapy after surgery from those at high risk of having a recurrence of their cancer and would be more likely to benefit from receiving chemotherapy after surgery.

Vascular Endothelial Growth Factor (VEGF) has been identified as a crucial regulator of both normal and abnormal angiogenesis (blood vessel formation) and increased levels of expression have been found in most human tumors including tumors of the gastrointestinal tract. Bevacizumab is an antiangiogenic (inhibits blood vessel formation) agent that prevents the binding of VEGF to its receptors, thus inhibiting new blood vessel formation.

In ECOG 5202, we are evaluating the potential benefit of combining bevacizumab administration with chemotherapy agents 5-FU, leucovorin, and oxaliplatin as treatment for high-risk stage II colon cancer patients.

Eligibility and Treatment Plan:
Patients, 18 years and older, with surgically removed adenocarcinoma of the colon (Stage II carcinoma T3,4 N0 M0), greater than 8 lymph nodes evaluated and reported, ECOG performance status 0-2, and distal extent of the tumor greater than 12 cm from the anal verge on endoscopy or surgical examination.

High-risk patients will be randomized to treatment arms A (oxaliplatin, 5-FU, leucovorin) or B (bevacizumab, oxaliplatin, 5-FU, leucovorin). Low-risk patients will be registered to arm C for observation. Please call for more information.

Benefits and/or Compensation:
Participants receive study-related medication at no charge under the supervision and care of a team of medical professionals. The information gathered from this study may be beneficial to future patients, and bevacizumab may improve overall survival time for high risk stage II colon cancer patients.