Phase II Trial Of Neoadjuvant Concurrent Capecitabine, RHUMAB VEGF (Avastin) And Radiotherapy In Patients Presenting With Locally Advanced Rectal Cancer
Avastin [RHUMAB VEGF, Bevacizumab] is a drug that has damaging effects on blood vessel
growth in tumors.
Before treatment starts, you will have a complete physical exam. About 2 tablespoons of
blood will be drawn for routine tests and a urine test will be performed. Chest x-rays and
CT scans of the abdomen and pelvis will be done. Women who are able to have children must
have a negative blood pregnancy test.
You will receive radiation therapy once a day for 5 days in a row (Monday-Friday) for 5
weeks and three days (a total of 28 treatments). You will take the chemotherapy drug
capecitabine by mouth twice a day on each of the days that you receive radiation therapy.
These pills will not be taken on Saturday and Sunday. You must not take cimetidine, and must
be off of coumadin for at least one week and sorivudine and brivudine for at least four
weeks before starting capecitabine and while taking capecitabine.
You will receive the drug Avastin by vein once every 2 weeks for six weeks (a total of three
doses). The infusion will at first last 90 minutes. If there are no allergic reactions,
fevers or chills, it will be shortened to 60 minutes and then 30 minutes for later
During the study, you will have physical exams, including weekly blood tests (about 2
teaspoons). The possible development of side effects will be closely monitored.
All participants will have surgical removal of the rectal tumor 6-8 weeks after the
completion of treatment as they would for the standard of care for their disease. No
patients will have surgery before 6 weeks.
After participation in this study is over, you will have follow-up evaluation as needed for
standard of care.
THIS IS AN INVESTIGATIONAL STUDY. Capecitabine is approved by the FDA, but Avastin has not
yet been evaluated for approval.
About 50 patients will take part in the study. All will be enrolled at the M. D. Anderson.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Pathologic Local Tumor Response
At follow-up evaluation after completion of neoadjuvant and surgical therapy, resected primary tumor classified based on routine pathology staining in the following manner: Pathologic Complete Response (no evidence of residual cancer); Microscopic Residual (no grossly detected disease, but evidence of microscopic residual disease); and Gross Residual Disease.
Baseline to approximately 5 Months (Following 28 days of treatment, chemotherapy and surgical resection of tumor)
Christopher H. Crane, MD
M.D. Anderson Cancer Center
United States: Food and Drug Administration
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