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Oral Colchicine in Men With Castrate Resistant Prostate Cancer

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ClinicalTrials.gov Identifier: NCT01481233
Recruitment Status : Withdrawn (Due to funding)
First Posted : November 29, 2011
Last Update Posted : September 27, 2013
Information provided by (Responsible Party):
Joseph Drabick, Milton S. Hershey Medical Center

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

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: Colchicine Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial of Oral Colchicine in Men With Castrate-Resistant Prostate Cancer Who Have Failed Taxotere-Based Chemotherapy
Study Start Date : May 2013
Actual Primary Completion Date : August 2013
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
Drug Information available for: Colchicine

Arm Intervention/treatment
Experimental: Single arm
Colchicine 0.5 mg BID x 21 days
Drug: Colchicine
Colchicine 0.6 mg bid to a maximum of 1.2 mg bid
Other Name: Colcrys

Primary Outcome Measures :
  1. PSA Response rate [ Time Frame: 63 days (3 cycles of treatment) ]
    Determine the PSA response rate to continuous low dose oral colchicine

Secondary Outcome Measures :
  1. Response rate [ Time Frame: 63 days (3 cycles) ]
    Determine the progression free survival

  2. Toxicity grading [ Time Frame: One year ]
    Determine the safety and tolerability of continuous low dose oral colchicine

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01481233

Sponsors and Collaborators
Milton S. Hershey Medical Center
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Principal Investigator: Joseph J Drabick, MD Milton S. Hershey Medical Center
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Responsible Party: Joseph Drabick, Professor of Medicine, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT01481233    
Other Study ID Numbers: PSHCI 09-023
First Posted: November 29, 2011    Key Record Dates
Last Update Posted: September 27, 2013
Last Verified: September 2013
Keywords provided by Joseph Drabick, Milton S. Hershey Medical Center:
oral colchicine
castrate-resistant prostate cancer
failed taxotere based chemotherapy
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Prostatic Diseases
Gout Suppressants
Antirheumatic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents