Oral Colchicine in Men With Castrate Resistant Prostate Cancer

Penn State Health

Status and phase: Withdrawn; Phase 2

Conditions: Prostate Cancer

Treatments: Drug: Colchicine

Study type: Interventional

Funder types: Other

Identifiers

NCT01481233

PSHCI 09-023

Details and patient eligibility

About

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

Full 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.

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Single arm

Experimental group

Description:

Colchicine 0.5 mg BID x 21 days

Treatment:

Drug: Colchicine