Study of Olaparib Maintenance Following Cabazitaxel-Carbo in Men With AVPC
brief 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.
detailed description
Study Groups:
If you are found to be eligible to take part in this study, you will be randomly assigned (as in a roll of dice) to 1 of 2 study groups. This is done because no one knows if one study group is better, the same, or worse than the other group. You will have a 2 in 3 chance of being assigned to Group 1 and a 1 in 3 chance of being assigned to Group 2:
* If you are in Group 1, you will receive olaparib. * If you are in Group 2, you will not receive olaparib.
All participants will receive cabazitaxel and carboplatin.
You and the study staff will know to which group you have been assigned.
Study Drug Administration:
Each study cycle is 21 days.
You will receive cabazitaxel by vein over 60 minutes on Day 1 of Cycles 1-6. You will then receive carboplatin by vein over 60 minutes on Day 1 of Cycles 1-6.
You will take 1 tablet of prednisone by mouth 2 times each day of Cycles 1-6.
You will be given standard drugs to help decrease the risk of side effects (for example, filgrastim) before and/or after each dose of cabazitaxel and continuing through several days. Your doctor will describe these drugs to you in more detail, including how they are given and any side effects you may expect.
If you are in Group 1, you will take tablets of olaparib 2 times by mouth each day starting on Day 1 of Cycle 7. Swallow the whole tablet or tablets. Do not chew, crush, divide, or dissolve the tablets. If you vomit shortly after taking your olaparib tablet you can retake a new dose as long as you can see that the tablet came out whole. You should take the doses at the same time each day (or within 2 hours of the scheduled times). Do not take the dose if you forget and it is more than 2 hours since your scheduled time. Take olaparib at least 1 hour after and 2 hours before eating.
If you are in Group 2, you will receive standard of care treatment and follow-up after Cycle 6. The study doctor will tell you more about what this may mean for you.
Length of Treatment:
official title
Randomized Phase II Study of Olaparib Maintenance Following Cabazitaxel-Carboplatin Induction Chemotherapy in Men With Aggressive Variant Prostate Cancer (AVPC)