A Phase I Study of Bavituximab, Capecitabine, and Radiation for the Treatment of Rectal Adenocarcinoma
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|ClinicalTrials.gov Identifier: NCT01634685|
Recruitment Status : Completed
First Posted : July 6, 2012
Last Update Posted : May 7, 2018
|Condition or disease||Intervention/treatment||Phase|
|Rectal Adenocarcinoma||Radiation: Radiation Drug: Bavituximab Drug: Capecitabine||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||August 8, 2012|
|Actual Primary Completion Date :||October 30, 2015|
|Actual Study Completion Date :||October 6, 2017|
Experimental: Bavituximab, Capecitabine, Radiation
Radiation therapy will be administered daily, Monday-Friday, for a total of 28 treatments, delivered at 1.8 Gy/fraction.
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.
Other Name: Phosphatidylserine-Targeting Antibody
capecitabine, will be delivered twice daily p.o. on the days of radiation treatment, at a dose of 825 mg/m2.
Other Name: Xeloda
- dose-limiting toxicities (DLT) [ Time Frame: 28 days ]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 ]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 ]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 ]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 ]To determine maximally tolerated dose (MTD) for bavituximab when administered on a weekly basis concurrently with external beam radiation therapy.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01634685
|United States, Texas|
|University of Texas Southwestern Medical Center|
|Dallas, Texas, United States, 75390|
|Principal Investigator:||Jeffrey Meyer, MD||University of Texas Southwestern Medical Center|