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

Phase 2
18 Years
Not Enrolling
Prostate Cancer

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Trial Information

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.

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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

PSA Response rate

Outcome Description:

Determine the PSA response rate to continuous low dose oral colchicine

Outcome Time Frame:

63 days (3 cycles of treatment)

Safety Issue:


Principal Investigator

Joseph J Drabick, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Milton S. Hershey Medical Center


United States: Institutional Review Board

Study ID:

PSHCI 09-023



Start Date:

May 2013

Completion Date:

January 2014

Related Keywords:

  • Prostate Cancer
  • oral colchicine
  • castrate-resistant prostate cancer
  • failed taxotere based chemotherapy
  • Prostatic Neoplasms



Penn State Milton S. Hershey Medical Center Hershey, Pennsylvania  17033