This subproject is one of many research subprojects utilizing theresources provided by a Center grant funded by NIH/NCRR. The subproject andinvestigator (PI) may have received primary funding from another NIH source,and thus could be represented in other CRISP entries. The institution listed isfor the Center, which is not necessarily the institution for the investigator.This study hypothesizes that bevacizumab (Avastin), an antibody against VEGF, will improve outcomes in patients with stage II and III rectal cancer who have previously received radiation and chemotherapy prior to surgery. The primary objective is to compare overall survival of patients treated with pre-surgical irradiation and chemotherapy and post-surgery oxaliplatin, 5-FU and leucovorin versus those treated with this regimen plus bevacizumab. Secondary objectives are to determine quality of life, tolerability of therapy, various prognostic markers and targets for chemotherapy, effect of diabetes on cancer recurrence and the effect of BMI and weight gain on cancer recurrence and survival. Study endpoints are death, various measures of quality of life. Patients will be randomized to receive either bevacizumab or nothing in addition to chemotherapy. 8 weeks after surgery, patients will receive 12 cycles of chemotherapy +/- bevacizumab every 2 weeks. Patients will be evaluated on a regular basis for survival, recurrence, and various drug toxicities. Bevacizumab has been used in patients with colon cancer but not rectal cancer. The efficacy/toxicity of this anti-angiogenic therapy will be evaluated for the first time in a prospective fashion in these patients after they have received pre-operative radiation and chemotherapy. Patients will be recruited from another ongoing trial of pre-operative chemoradiation therapy.
Showing the most recent 10 out of 470 publications