Bavituximab Trials PDF Print E-mail

Phase I Trial: IST of bavituximab in combination with capecitabine and radiation therapy in patients with advanced rectal cancer

Status: Active, not Recruiting

Focus: Stage II or III Rectal Adenocarcinoma

This is a Phase I single-arm, open-label, dose-escalation trial will enroll up to 18 patients with stage II or III rectal adenocarcinoma, with Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. Patients will receive weekly bavituximab for a total of 8 weeks with administration of capecitabine (825 mg/m2) on each of the 28 days of radiation therapy (1.8 Gy/fraction) over 6 weeks, followed by 2 weeks of bavituximab administration by itself. Surgery will follow the last bavituximab administration by 4-8 weeks (i.e., 6-10 weeks following completion of radiation therapy). The primary endpoint is to determine the safety, feasibility and tolerability of combining bavituximab with a standard platform of capecitabine and radiation therapy. Secondary endpoints include the assessment of any anti-tumor activity by objective response as determined by MR imaging and histopathological response in patients.

Rectal cancer occurs on the last eight to 10 inches of the colon. They are often referred to together as colorectal cancers, and are the second leading cause of cancer-related deaths in the United States.

The unique identifier for this trial on ClinicalTrials.gov is NCT01634685

 

Citations to above market statements are available upon request.