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Oral Colchicine in Men With Castrate Resistant Prostate Cancer

NCT ID: NCT01481233

Last Updated: 2013-09-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2013-08-31

Brief Summary

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

Detailed Description

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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

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Prostate Cancer

Keywords

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oral colchicine castrate-resistant prostate cancer failed taxotere based chemotherapy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

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Colchicine

Colchicine 0.6 mg bid to a maximum of 1.2 mg bid

Intervention Type DRUG

Other Intervention Names

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Colcrys

Eligibility Criteria

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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

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Milton S. Hershey Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Joseph Drabick

Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Joseph J Drabick, MD

Role: PRINCIPAL_INVESTIGATOR

Milton S. Hershey Medical Center

Countries

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United States

Other Identifiers

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PSHCI 09-023

Identifier Type: -

Identifier Source: org_study_id