Oral Colchicine in Men With Castrate Resistant Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01481233
• Other study ID #: PSHCI 09-023
• Status: Withdrawn
• Phase: Phase 2
• First received: November 11, 2011
• Last updated: September 26, 2013
• Start date: May 2013
• Est. completion date: August 2013

Study information

• Verified date: September 2013
• Source: Milton S. Hershey Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Colchicine
Colchicine 0.6 mg bid to a maximum of 1.2 mg bid

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Milton S. Hershey Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PSA Response rate	Determine the PSA response rate to continuous low dose oral colchicine	63 days (3 cycles of treatment)	Yes
Secondary	Response rate	Determine the progression free survival	63 days (3 cycles)	Yes
Secondary	Toxicity grading	Determine the safety and tolerability of continuous low dose oral colchicine	One year	Yes