NCT01634685

A Phase I Study of Bavituximab, Capecitabine, and Radiation for the Treatment of Rectal Adenocarcinoma

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: University of Texas Southwestern Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

The investigational drug in this protocol is bavituximab, which will be delivered concurrently with the radiation therapy for 6 weeks (one time each week), followed by 2 weeks of bavituximab administration by itself. If the other therapies are terminated after week 4 the bavituximab treatment may be continued per protocol. A chemotherapy agent, capecitabine, will be delivered twice daily p.o. on the days of radiation treatment, at a dose of 825 mg/m2. Radiation therapy will be administered daily, Monday-Friday, for a total of 28 treatments, delivered at 1.8 Gy/fraction. Surgery will follow the last bavituximab administration by 4-8 weeks (6-10 weeks following completion of radiation therapy.

Conditions

• Rectal Adenocarcinoma

Interventions

Type	Name	Description
RADIATION	Radiation	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.

Timeline

• Start date: 2012-08-08
• Primary completion: 2015-10-30
• Completion: 2017-10-06
• First posted: 2012-07-06
• Last updated: 2020-08-20

Locations

1 site across 1 country: United States