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Spots Global Cancer Trial Database for Oral Colchicine in Men With Castrate Resistant Prostate Cancer

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We do not endorse or review these studies in any way.

Trial Identification

Brief Title: Oral Colchicine in Men With Castrate Resistant Prostate Cancer

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

Study ID: NCT01481233

Conditions

Prostate Cancer

Interventions

Colchicine

Study Description

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 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

Eligible Ages: ADULT, OLDER_ADULT

Sex: MALE

Healthy Volunteers: No

Locations

Contact Details

Name: Joseph J Drabick, MD

Affiliation: Milton S. Hershey Medical Center

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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