Phase II Trial of Oral Colchicine in Men With Castrate-Resistant Prostate Cancer Who Have Failed Taxotere-Based Chemotherapy
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.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
PSA Response rate
Determine the PSA response rate to continuous low dose oral colchicine
63 days (3 cycles of treatment)
Yes
Joseph J Drabick, MD
Principal Investigator
Milton S. Hershey Medical Center
United States: Institutional Review Board
PSHCI 09-023
NCT01481233
May 2013
January 2014
Name | Location |
---|---|
Penn State Milton S. Hershey Medical Center | Hershey, Pennsylvania 17033 |