Oral Colchicine in Men With Castrate Resistant Prostate Cancer

NCT ID: NCT01481233

Last Updated: 2013-09-27

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2013-08-31

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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Single arm

Colchicine 0.5 mg BID x 21 days

Group Type: EXPERIMENTAL

Colchicine

Intervention Type: DRUG

Colchicine 0.6 mg bid to a maximum of 1.2 mg bid

Interventions

Colchicine

Colchicine 0.6 mg bid to a maximum of 1.2 mg bid

Intervention Type: DRUG

Other Intervention Names

Colcrys

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Milton S. Hershey Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Joseph Drabick

Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Joseph J Drabick, MD

Role: PRINCIPAL_INVESTIGATOR

Milton S. Hershey Medical Center

Other Identifiers

PSHCI 09-023

Identifier Type: -

Identifier Source: org_study_id