Phase I Trial of PACE for Metastatic Prostate Cancer
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|ClinicalTrials.gov Identifier: NCT03110588|
Recruitment Status : Recruiting
First Posted : April 12, 2017
Last Update Posted : September 12, 2019
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Prostate Cancer||Drug: PACE with Cabazitaxel (15 mg/m2) Drug: PACE with Cabazitaxel (20 mg/m2)||Phase 1|
Multiple agents have been shown to improve survival in patients with mCRPC by up to five months. The combination of prednisone, abiraterone, cabazitaxel and enzalutamide may be anticipated to be feasible therapy with minimal or no adverse drug interactions. This is a phase I trial to study the feasibility of the proposed therapy.
Patients will undergo a combination of oral daily drug intake at varying doses over a period of three weeks. Monitoring including blood collection for laboratory testing will be done on Day 1 of each three-week cycle with additional monitoring during the first cycle. Imaging and correlative studies will be done every 12 weeks. Therapy will continue until disease progression or severe toxicities.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||12 participants|
|Intervention Model:||Sequential Assignment|
|Intervention Model Description:||The first cohort will administer the following to three patients: prednisone 5 mg orally twice daily, abiraterone 1000 mg orally once daily, enzalutamide 160 mg orally once daily, and cabazitaxel intravenous infusion at 15 mg/m2 every 3 weeks. If there are no dose limiting toxicities, the cabazitaxel will be escalated to 20 mg/m2 in a second cohort. The other three drugs will remain at the same dose.|
|Masking:||None (Open Label)|
|Official Title:||Phase I Trial of Prednisone, Abiraterone, Cabazitaxel and Enzalutamide (PACE) for Metastatic Castration-resistant Prostate Cancer (mCRPC)|
|Actual Study Start Date :||July 1, 2018|
|Estimated Primary Completion Date :||August 1, 2021|
|Estimated Study Completion Date :||August 1, 2023|
Experimental: PACE with Cabazitaxel @ 15 mg/m2
The drugs to be administered are: prednisone 5 mg orally twice daily, abiraterone 1000 mg orally once daily, enzalutamide 160 mg orally once daily, and cabazitaxel intravenous infusion at 15 mg/m2 every 3 weeks.
Drug: PACE with Cabazitaxel (15 mg/m2)
Prednisone, Abiraterone, and Enzalutamide are administered orally; Cabazitaxel is be administered intravenously @ 15 mg/m2.
Experimental: PACE with Cabazitaxel @ 20 mg/m2
The drugs to be administered are: prednisone 5 mg orally twice daily, abiraterone 1000 mg orally once daily, enzalutamide 160 mg orally once daily, and cabazitaxel intravenous infusion at 20 mg/m2 every 3 weeks.
Drug: PACE with Cabazitaxel (20 mg/m2)
Prednisone, Abiraterone, and Enzalutamide are administered orally; Cabazitaxel is be administered intravenously @ 20 mg/m2.
- Maximum tolerated dose of PACE as first-line therapy [ Time Frame: Baseline up to 2 years ]The maximum tolerated dose is when 6 patients are treated at a dose level with less than two patients demonstrating dose limiting toxicities. Dose limiting toxicities are defined as any grade greater than or equal to grade 3 non-hematologic toxicity (except greater than or equal to grade 2 neurotoxicity), or greater than or equal to grade 4 neutropenia or thrombocytopenia lasting longer than or equal to 7 days. Toxicities will be assessed according to the NCI Common Terminology Criteria for Adverse Events version 4.03.
- Prostate specific antigen (PSA) [ Time Frame: Baseline up to 2 years ]PSA with a greater than or equal to 30% result within 12 weeks from baseline or the previous result and maximum declines at any time during the study progression. PSA will be tested at least every 3 weeks.
- Radiographic progression-free survival with PACE [ Time Frame: Baseline up to 2 years ]Radiographic examination is performed every 12 weeks to determine if there is disease progression.
- Progression-free survival with PACE [ Time Frame: Baseline up to 2 years ]Progression-free survival is defined as the duration of time from start of treatment to time of progression or death, whichever comes first.
- Objective response rate of measurable disease [ Time Frame: Baseline up to 2 years ]Response will be evaluated using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST 1.1). Changes in only the largest diameter (unidimensional measurement) of the tumor lesions are used in the RECIST criteria. Target lesions should be selected based on size (lesions with the longest diameter) and their suitability for accurate repeated measurements. A sum of the longest diameter (LD) for all target lesions will be calculated and reported as the baseline sum LD, which will be used to characterize the objective tumor response.
- Pain response [ Time Frame: Baseline up to 2 years ]The Patient Pain Index (0-5 scale) is used to measure pain per cycle. A decline of greater than or equal to 2 is defined as pain response.
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): NCT03110588
|Contact: Mansoor N Saleh, MDfirstname.lastname@example.org|
|Contact: Alfreda Lewis||205-975-9025||FredaLewis@uab.edu|
|United States, Alabama|
|University of Alabama at Birmingham||Recruiting|
|Birmingham, Alabama, United States, 35294|
|Contact: Mansoor N Saleh, MD 205-996-4673 email@example.com|
|Contact: Alfreda Lewis 205-975-9025 FredaLewis@uab.edu|
|Principal Investigator:||Mansoor N Saleh, MD||University of Alabama at Birmingham|