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This study has been withdrawn prior to enrollment.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
  Purpose

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


Condition Intervention Phase
Prostate Cancer
Drug: Colchicine
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Milton S. Hershey Medical Center:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Enrollment: 0
Study Start Date: May 2013
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01481233

Sponsors and Collaborators
Milton S. Hershey Medical Center
Investigators
Principal Investigator: Joseph J Drabick, MD Milton S. Hershey Medical Center
  More Information

No publications provided

Responsible Party: Joseph Drabick, Professor of Medicine, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT01481233     History of Changes
Other Study ID Numbers: PSHCI 09-023
Study First Received: November 11, 2011
Last Updated: September 26, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Milton S. Hershey Medical Center:
oral colchicine
castrate-resistant prostate cancer
failed taxotere based chemotherapy

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Colchicine
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Gout Suppressants
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents

ClinicalTrials.gov processed this record on July 28, 2014