Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2025-12-31 @ 1:26 PM
Study NCT ID:
NCT01481233
Status:
WITHDRAWN
Last Update Posted:
2013-09-27
First Post:
2011-11-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Oral Colchicine in Men With Castrate Resistant Prostate Cancer
Sponsor:
Milton S. Hershey Medical Center
Organization:
Study Overview
Official Title:
Phase II Trial of Oral Colchicine in Men With Castrate-Resistant Prostate Cancer Who Have Failed Taxotere-Based Chemotherapy
Status:
WITHDRAWN
Status Verified Date:
2013-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Due to funding
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: