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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
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.
capecitabine, will be delivered twice daily p.o. on the days of radiation treatment, at a dose of 825 mg/m2.
University of Texas Southwestern Medical Center
Dallas, Texas, United States
dose-limiting toxicities (DLT)
To determine dose-limiting toxicities (DLT) for bavituximab when administered on a weekly basis concurrently with external beam radiation therapy.
Time frame: 28 days
adverse events
To describe the adverse events associated with bavituximab when administered on a weekly basis concurrently with external beam irradiation and capecitabine
Time frame: 12 weeks
MR imaging and histopathological response
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.
Time frame: 12 weeks
tumor-vasculature parameters
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.
Time frame: week 3 and 12
maximally tolerated dose (MTD)
To determine maximally tolerated dose (MTD) for bavituximab when administered on a weekly basis concurrently with external beam radiation therapy.
Time frame: 28 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.