Oral Colchicine in Men With Castrate Resistant Prostate Cancer

• Status: Withdrawn
• Trial end date: 2013-08-01
• Target enrollment: 0
• Participant gender: Male

Summary

The purpose of this study is to determine the prostate specific antigen response to continuous low dose oral colchicine.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Milton S. Hershey Medical Center
• Treatments: Colchicine

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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