Clinical trial NCT00113230
Conditions: Rectal Cancer
Keywords: Rectal Cancer Bevacizumab RHUMAB VEGF Avastin Capecitabine Neoadjuvant Concurrent Capecitabine Xeloda Radiation Radiotherapy Radiation Therapy XRT
Sponsor: M.D. Anderson Cancer Center
Start date: 2005-02-01; Completion date: 2009-01-01
Enrollment: 25 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Preoperative chemoradiation leads to increased pelvic control and overall survival, but both distant and local disease control remain problematic in locally advanced rectal cancer patients. Enhancing the effect of chemotherapy and radiotherapy can increase tumor response as well as distant disease control. Patients who have complete response to therapy have increased sphincter preservation, and can possibly have more limited surgery (full thickness local excision). When combined with standard chemotherapy, bevacizumab \[RHUMAB VEGF, Avastin\] has been shown to improve response and median survival in patients with metastatic colorectal cancer in a recent randomized trial, has led to increased activity in preclinical studies with radiotherapy, and has been found to be very well tolerated with chemoradiation in a phase I trial conducted at the M.D. Anderson Cancer Center (MDACC) in patients with locally advanced pancreatic cancer. The hypothesis is that the addition of bevacizumab to standard chemoradiation will safely lead to increased tumor response in patients with locally advanced rectal cancer.

Detailed description:
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 infusions.

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.

Arms: arm 1: Capecitabine, Avastin (RHUMAB VEGF/Bevacizumab) And Radiotherapy
Interventions: intervention 1: Avastin (Bevacizumab, RHUMAB VEGF) intervention 2: Capecitabine intervention 3: Radiation Therapy
Intervention descriptions: intervention 1: Starting Dose 5 mg/kg intravenously on day one of radiotherapy, given every 2 weeks +/- 2 days for a total of 3 doses. intervention 2: 900 mg/m\^2 by mouth twice a day during days of radiation for all five weeks of therapy. intervention 3: 45 Gy in 25 fractions to the pelvis followed by 5.4 Gy as a boost dose to the primary tumor with margin, for a total dose of 50.4 Gy over 28 treatment days.

Protocol documents: