Status:
WITHDRAWN
Oral Colchicine in Men With Castrate Resistant Prostate Cancer
Lead Sponsor:
Milton S. Hershey Medical Center
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine the prostate specific antigen response to continuous low dose oral colchicine.
Detailed Description
The investigators propose a simple phase II trial of oral colchicine at the standard prophylactic dose utilized for gout in men with CRPCa who have failed taxotere based chemotherapy. The investigator...
Eligibility Criteria
Inclusion
- Castrate resistant prostate cancer
- Failure or intolerance of taxotere or cabazitaxel-based chemotherapy or abiraterone administered for castrate resistant prostate cancer is allowed
- Age \> 18 years and ability to provide informed consent
- ECOG performance status of 0, 1 or 2
- No prior use of colchicine within the last 2 years
- No chemotherapy, hormonal therapy, immunotherapy or radiation therapy within 1 month of day 1, cycle 1
Exclusion
- Inability to provide informed consent
- Hypersensitivity to colchicine
- Severe renal, gastrointestinal or hepatic disorders
- Pre-existing blood dyscrasia
- PLT \< 100K, ANC \< 1000
- Serum Cr \> 2 x ULN
- Bilirubin \> 2 ULN
- AST \> 2 x ULN
- Concurrent use of CYP3A4 inhibitors which may increase drug levels and toxicity
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2013
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01481233
Start Date
May 1 2013
End Date
August 1 2013
Last Update
September 27 2013
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