Clinical trial NCT01335204
Conditions: Prostate Cancer Prostatic Neoplasms
Keywords: Castration-resistant prostate cancer Prostate Cancer JEVTANA Cabazitaxel Bavituximab
Sponsor: Medical University of South Carolina
Start date: 2011-06-01; Completion date: 2013-03-01
Enrollment: 4 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a Phase Ib/IIa Study of Cabazitaxel plus Bavituximab in patients with castration-resistant prostate cancer (CRPC). The current study is designed to determine if the addition of bavituximab to cabazitaxel will improve progression free survival (PFS) or overall survival (OS). In addition, the Lead Researcher is requiring the collection of urine, and blood specimens for future research.

This study will enroll patients with CRPC, who have been previously treated with docetaxel or a docetaxel-containing regimen. Patients may be intolerant of, or resistant to, docetaxel, or may have been previously treated with the agent without definite disease progression during therapy.

Patients must meet the study eligibility criteria and must be competent to give informed consent.

Detailed description:
Cabazitaxel will be administered IV on day 1 of each 21-day treatment cycle. Bavituximab (3 mg/kg) will be administered as an intravenous (IV) infusion on a weekly basis (Cycle 1 Day 2, all other cycles Day 1; day 8, day 15). Patients will receive cabazitaxel (day 1) plus bavituximab weekly of each 21-day cycle for up to 8 cycles.

Up to 31 patients will be enrolled to ensure 28 evaluable subjects. The accrual period is expected to be between 12 to 18 months (1-1.5 years).

Subjects will remain on the treatment phase of the study until any of the following events occur:

* Disease progression as evidenced by an increase in the prostate-specific antigen (PSA) level, worsening of pain, or disease progression by Response Evaluation Criteria in Solid Tumors (RECIST)
* Completion of 8 cycles of cabazitaxel-bavituximab therapy (day 169)
* Development of toxicity that, in the investigator's judgment, precludes further study participation
* Significant protocol violations or noncompliance on the part of the patient or investigator
* The investigator's judgment that discontinuation is in the patient's best interest
* Initiation of alternative antineoplastic treatments.
* Refusal of the patient to continue treatment or follow-up
* Loss to follow-up

After completion of the treatment phase, subjects will remain on the followup phase of the study until any of the following events occur:

* Refusal of the patient to continue treatment or follow-up
* Loss to follow-up
* Death
* The investigator's judgment that discontinuation is in the patient's best interest

Arms: arm 1: Cabazitaxel (25 mg/m2) will be administered IV on Day 1 of each 21-day treatment cycle. Bavituximab (3 mg/kg) will be administered as an IV infusion on a weekly basis (Cycle 1 Day 2, all other cycles Day 1; day 8; day 15) for 8 cycles.
Interventions: intervention 1: Cabazitaxel plus bavituximab
Intervention descriptions: intervention 1: Cabazitaxel (25 mg/m2) will be administered IV on Day 1 of each 21-day treatment cycle, and bavituximab (3 mg/kg) will be administered as an IV infusion on a weekly basis (Cycle 1 Day 2, all other cycles Day 1; day 8; day 15) for 8 cycles.

Protocol documents: