A Phase I Study of Bavituximab, Capecitabine, and Radiation for the Treatment of Rectal Adenocarcinoma
This is a phase I study incorporating bavituximab into the care of patients with rectal adenocarcinoma simultaneously treated with capecitabine and radiation therapy. There is no reference therapy as we are trying to identify the MTD of bavituximab in this combination.
Stage II and III Rectal Adenocarcinoma
Radiation: Radiation Therapy
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I Study of the Phosphatidylserine-Targeting Antibody Bavituximab in Combination With Capecitabine and Radiation Therapy for the Treatment of Stage II and III Rectal Adenocarcinoma|
- dose-limiting toxicities (DLT) [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]To determine dose-limiting toxicities (DLT) for bavituximab when administered on a weekly basis concurrently with external beam radiation therapy.
- adverse events [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]To describe the adverse events associated with bavituximab when administered on a weekly basis concurrently with external beam irradiation and capecitabine
- MR imaging and histopathological response [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]To describe any preliminary evidence of anti-tumor activity by assessment of objective response as determined by MR imaging and histopathological response in patients with T3-4 and/or node-positive rectal adenocarcinoma.
- tumor-vasculature parameters [ Time Frame: week 3 and 12 ] [ Designated as safety issue: No ]To determine if the combination of bavituximab, capecitabine, and radiation therapy induces changes in tumor-vasculature parameters as assessed by DCE-MRI, in selected patients.
- maximally tolerated dose (MTD) [ Time Frame: 28 days ] [ Designated as safety issue: No ]To determine maximally tolerated dose (MTD) for bavituximab when administered on a weekly basis concurrently with external beam radiation therapy.
|Study Start Date:||August 2012|
|Estimated Study Completion Date:||June 2016|
|Estimated Primary Completion Date:||August 2014 (Final data collection date for primary outcome measure)|
Experimental: Bavituximab, Capecitabine, and Radiation
Radiation: Radiation Therapy
Radiation therapy will be administered daily, Monday-Friday, for a total of 28 treatments, delivered at 1.8 Gy/fraction.Drug: Bavituximab
Bavituximab will be delivered concurrently with the radiation therapy for 6 weeks (one time each week), followed by 2 weeks of bavituximab administration by itself.Drug: Capecitabine
capecitabine, will be delivered twice daily p.o. on the days of radiation treatment, at a dose of 825 mg/m2.
|Contact: Jeffrey Meyer, MD||214-645-8525|
|Contact: Jean Wu, MSN||214-645-8525|
|United States, Texas|
|University of Texas Southwestern Medical Center||Recruiting|
|Dallas, Texas, United States, 75390|
|Principal Investigator: Jeffrey Meyer, MD|
|Principal Investigator:||Jeffrey Meyer, MD||University of Texas Southwestern Medical Center|