Phase 2 Trial of Carfilzomib for Metastatic Castration-resistant Prostate Cancer Following Treatment
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|ClinicalTrials.gov Identifier: NCT02047253|
Recruitment Status : Completed
First Posted : January 28, 2014
Results First Posted : December 19, 2018
Last Update Posted : December 19, 2018
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Castration-resistant Prostate Cancer||Drug: Carfilzomib Drug: Dexamethasone Drug: Acyclovir||Phase 2|
First-line chemotherapy for metastatic castration-resistant prostate cancer (CRPC) combined with androgen inhibitors modestly extends overall survival. Carfilzomib is anticipated to enhance progression-free survival (PFS) as well as reduce pain and toxicities.
Proteasome inhibitors are promising agents used in the therapy of prostate cancer. Carfilzomib is a more potent and irreversible proteasome inhibitor than the frequently used proteasome inhibitor, Bortezomib. In Phase I trials Carfilzomib demonstrated substantial antitumor activity while exhibiting tolerable side effects.
Carfilzomib has been approved by the FDA for patients with multiple myeloma. The drug, however, is not approved for the use with CRPC patients. This trial will evaluate the tolerance and effectiveness of Carfilzomib in men with metastatic progressive CRPC following chemotherapy and androgen inhibitors.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||28 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2 Trial of Carfilzomib for Metastatic Castration-resistant Prostate Cancer Following Chemotherapy and Androgen Pathway Inhibitors|
|Actual Study Start Date :||April 2014|
|Actual Primary Completion Date :||June 8, 2017|
|Actual Study Completion Date :||July 14, 2017|
Carfilzomib is administered twice-weekly on consecutive days (days 1, 2, 8, 9, 15, 16) as a 30-minute intravenous infusion for 3 weeks every 4 weeks (1 cycle) with dexamethasone given as pre-medication. The dose of carfilzomib is 20 mg/m2 on days 1 and 2 of cycle 1 and is then escalated in succeeding weeks and cycles to 56 mg/m2 if no dose limiting toxicities occur. Acyclovir is given orally at 400 mg twice daily during therapy but may be discontinued at some point. Therapy will continue until side effects become unacceptable, the disease progresses, or the doctor withdraws the patient.
Carfilzomib will be administered on days 1, 2, 8, 9, 15, 16 within each 4 week cycle.
Other Name: Kyprolis
Administered prior to administration of Study drug
Administered orally twice daily
Other Name: Zovirax
- Progression-free Survival (PFS) [ Time Frame: Baseline through 6 months for evaluating all patients ]The study will measure patient survival at 6 months but will continue to monitor overall survival as a secondary objective. The Kaplan-Meier method will be used.
- Overall Survival [ Time Frame: From baseline through 36 months. ]Outcome measure was completed by using a count of participants.
- Number of Participants With Prostate-Specific Antigen (PSA) Changes [ Time Frame: Baseline through 36 months ]PSA levels were collected at each visit on the day of treatment. Linear regression with PSA as the dependent variable and time as the dependent variable was performed.
- Number of Participants With Circulating Tumor Cell (CTC) Decline Over Three Time Points (Before Study Initiation, Day 1 of Cycles 2 and 4 [ Time Frame: Baseline through 36 months ]
The CTC marker will be used to evaluate efficacy of response to treatment. CTC changes will include changes from unfavorable (less than or equal to 5/7.5 ml) to favorable and declines by >30%.
Three collections: before study initiation, Day 1 of Cycles 2 and 4
- Assessment of Toxicities [ Time Frame: Baseline through 36 months ]
Hematologic and non-hematologic toxicities will be graded. The new international criteria proposed by the Response Evaluation Criteria In Solid Tumors (RECIST) will serve as the guideline.
On Day 1 of each cycle (4 weeks) for the duration of treatment and then 30 days following the last treatment
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): NCT02047253
|United States, Alabama|
|Birmingham VA Medical Center|
|Birmingham, Alabama, United States, 35233|
|University of Alabama at Birmingham|
|Birmingham, Alabama, United States, 35294|
|United States, Georgia|
|Cancer Life Center, Navicent Health|
|Macon, Georgia, United States, 31210|
|United States, Louisiana|
|University of Tulane|
|New Orleans, Louisiana, United States, 70118|
|Principal Investigator:||Guru Sonpavde, MD||University of Alabama at Birmingham|
|Study Chair:||Mansoor Saleh, MD||Georgia Cancer Specialists|