At a glance
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Randomized Phase II Study of Olaparib Maintenance Following Cabazitaxel-Carboplatin Induction Chemotherapy in Men With Aggressive Variant Prostate Cancer (AVPC)
In Brief
A Phase 2 clinical trial evaluating Cabazitaxel, Carboplatin, and 2 other interventions for Prostate Cancer Aggressiveness and Prostate Carcinoma. Completed, enrolled 96 participants across 1 site.
Detailed Summary
The goal of this clinical research study is to learn if olaparib, when given after treatment with cabazitaxel, carboplatin, and prednisone, can help to control aggressive variant prostate cancer (AVPC). The safety of these drugs will also be studied. This is an investigational study. Cabazitaxel and carboplatin are FDA approved and commercially available for the treatment of certain types of prostate cancer. Prednisone is FDA-approved and commercially available as a corticosteroid. Olaparib is FDA approved and commercially available for the treatment of certain types of ovarian cancer. The combination of cabazitaxel and carboplatin followed by olaparib in this study is investigational. The study doctor can describe how the study drugs are designed to work. Up to 96 participants will be enrolled on this study. All will take part at MD Anderson.
Study Details
Timeline
Arms & Interventions
Cabazitaxel, Cabazitaxel and Carboplatin intravenously on day 1 of cycles 1-6. Prednisone by mouth twice daily on days 1-21 of cycles 1-6.
Participants randomized to receive Olaparib by mouth twice daily on Day 1 of cycle 7.
Participants randomized to observation only beginning cycle 7.
Interventions
25mg/m2 administered intravenously over 60 minutes on day 1 of cycles 1-6; given before carboplatin.
AUC 4 administered intravenously over 60 minutes on day 1 of cycles 1-6
5 mg administered by mouth twice daily on days 1-21 of cycles 1-6.
Administered by mouth twice daily at a dose of 300 mg by mouth twice daily, dispensed on Day 1 of cycle 7 to participants randomized to receive olaparib maintenance and every 21 days thereafter until the participant completes the study, withdraws from the study or the closure of the study.