Oral Colchicine in Men With Castrate Resistant Prostate Cancer

This study has been withdrawn prior to enrollment.
(Due to funding)
Sponsor:
Information provided by (Responsible Party):
Joseph Drabick, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier:
NCT01481233
First received: November 11, 2011
Last updated: September 26, 2013
Last verified: September 2013

November 11, 2011
September 26, 2013
May 2013
August 2013   (final data collection date for primary outcome measure)
PSA Response rate [ Time Frame: 63 days (3 cycles of treatment) ] [ Designated as safety issue: Yes ]
Determine the PSA response rate to continuous low dose oral colchicine
Same as current
Complete list of historical versions of study NCT01481233 on ClinicalTrials.gov Archive Site
  • Response rate [ Time Frame: 63 days (3 cycles) ] [ Designated as safety issue: Yes ]
    Determine the progression free survival
  • Toxicity grading [ Time Frame: One year ] [ Designated as safety issue: Yes ]
    Determine the safety and tolerability of continuous low dose oral colchicine
Same as current
Not Provided
Not Provided
 
Oral Colchicine in Men With Castrate Resistant Prostate Cancer
Phase II Trial of Oral Colchicine in Men With Castrate-Resistant Prostate Cancer Who Have Failed Taxotere-Based Chemotherapy

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

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
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Prostate Cancer
Drug: Colchicine
Colchicine 0.6 mg bid to a maximum of 1.2 mg bid
Other Name: Colcrys
Experimental: Single arm
Colchicine 0.5 mg BID x 21 days
Intervention: Drug: Colchicine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
August 2013
August 2013   (final data collection date for primary outcome measure)

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
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01481233
PSHCI 09-023
Yes
Joseph Drabick, Milton S. Hershey Medical Center
Milton S. Hershey Medical Center
Not Provided
Principal Investigator: Joseph J Drabick, MD Milton S. Hershey Medical Center
Milton S. Hershey Medical Center
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP