Study of Olaparib Maintenance Following Cabazitaxel-Carbo in Men With AVPC
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|ClinicalTrials.gov Identifier: NCT03263650|
Recruitment Status : Recruiting
First Posted : August 28, 2017
Last Update Posted : January 15, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer Aggressiveness Prostate Carcinoma||Drug: Cabazitaxel Drug: Carboplatin Drug: Prednisone 5Mg Drug: Olaparib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||96 participants|
|Intervention Model:||Sequential Assignment|
|Intervention Model Description:||All participants will receive 6 cycles of cabazitaxel and carboplatin before being randomized 2:1 to olaparib maintenance versus observation.|
|Masking:||None (Open Label)|
|Official Title:||Randomized Phase II Study of Olaparib Maintenance Following Cabazitaxel-Carboplatin Induction Chemotherapy in Men With Aggressive Variant Prostate Cancer (AVPC)|
|Actual Study Start Date :||October 3, 2017|
|Estimated Primary Completion Date :||October 2020|
|Estimated Study Completion Date :||October 2020|
Experimental: Cabazitaxel + Carboplatin
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.
25mg/m2 administered intravenously over 60 minutes on day 1 of cycles 1-6; given before carboplatin.
Other Name: Jevtana
AUC 4 administered intravenously over 60 minutes on day 1 of cycles 1-6
Other Name: Paraplatin
Drug: Prednisone 5Mg
5 mg administered by mouth twice daily on days 1-21 of cycles 1-6.
Experimental: Olaparib Maintenance
Participants randomized to receive Olaparib by mouth twice daily on Day 1 of cycle 7.
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.
Other Name: Olaparib Pill
No Intervention: Observation Only
Participants randomized to observation only beginning cycle 7.
- Progression-free survival (PFS) of men with AVPC treated with 6 cycles of cabazitaxel + carboplatin followed by olaparib maintenance versus observation [ Time Frame: Up to one year from time of randomization ]
Progression Free Survival (PFS) calculated as the time from randomization until any one of the following events occurs, whichever comes first:
- Documented disease progression
- Start of a new therapy in the absence of progression
- Death in the absence of progression
- Genomic alterations in DNA damage repair (DDR) pathway genes induced and/or selected by carboplatin and cabazitaxel chemotherapy [biopsy #2 vs biopsy #1]: Association with clinical outcome (PFS>6 months) [ Time Frame: Up to one year ]
- Rate of adverse events possibly, probably or definitely attributable to olaparib following cabazitaxel plus carboplatin in men with AVPC [ Time Frame: Up to one year ]
- Overall survival (OS) of men with AVPC treated with 6 cycles of cabazitaxel + carboplatin followed by olaparib maintenance vs observation [ Time Frame: Up to one year ]
- Response evaluation criteria in solid tumors (RECIST) and prostate specific antigen (PSA) response rate (RR) to cabazitaxel + carboplatin induction, and to olaparib maintenance in men with AVPC [ Time Frame: Up to one year ]
- Association between DDR pathway gene expression changes following carboplatin + cabazitaxel chemotherapy and clinical outcome (PFS>6 months) [ Time Frame: Up to one year ]
- Collection and archiving of serum, plasma, and urine samples in study patients for later hypothesis generating associations [ Time Frame: Up to one year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03263650
|Contact: Ana M. Aparicio, MDemail@example.com|
|United States, Texas|
|University of Texas MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Ana M. Aparicio, MD 713-792-2830|
|Study Chair:||Ana M. Aparicio, MD||UT MD Anderson Cancer Center|