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Oral Colchicine in Men With Castrate Resistant Prostate Cancer

Information source: Milton S. Hershey Medical Center
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Prostate Cancer

Intervention: Colchicine (Drug)

Phase: Phase 2

Status: Withdrawn

Sponsored by: Milton S. Hershey Medical Center

Official(s) and/or principal investigator(s):
Joseph J Drabick, MD, Principal Investigator, Affiliation: Milton S. Hershey Medical Center

Summary

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

Clinical Details

Official title: Phase II Trial of Oral Colchicine in Men With Castrate-Resistant Prostate Cancer Who Have Failed Taxotere-Based Chemotherapy

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: PSA Response rate

Secondary outcome:

Response rate

Toxicity grading

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 investigators will utilize a simple modified Simon 2-stage design. The investigators plan to enroll 40 men for the study. The men should have completed prior taxotere based therapy or any other therapy post-taxotere including cabazitaxel one month prior to receipt of colchicine on trial. Staging with a baseline bone scan, CT and PSA as well as routine CBC, CMP and PAP. The dose of the drug can be escalated as tolerated to a maximum of 1. 2 mg bid. The patient would be seen at 21 day intervals. After every 3 cycles of treatment, patient would be restaged with CT and bone scan. Patients with stable disease, partial response or complete response would continue therapy until either disease progression or intolerable toxicity after which the patient would be taken off study.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Male.

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

Locations and Contacts

Additional Information

Starting date: May 2013
Last updated: September 26, 2013

Page last updated: August 20, 2015

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