Oral Colchicine in Men With Castrate Resistant Prostate Cancer
Primary Purpose
Prostate Cancer
Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Colchicine
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring oral colchicine, castrate-resistant prostate cancer, failed taxotere based chemotherapy
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Single arm
Arm Description
Colchicine 0.5 mg BID x 21 days
Outcomes
Primary Outcome Measures
PSA Response rate
Determine the PSA response rate to continuous low dose oral colchicine
Secondary Outcome Measures
Response rate
Determine the progression free survival
Toxicity grading
Determine the safety and tolerability of continuous low dose oral colchicine
Full Information
NCT ID
NCT01481233
First Posted
November 11, 2011
Last Updated
September 26, 2013
Sponsor
Milton S. Hershey Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01481233
Brief Title
Oral Colchicine in Men With Castrate Resistant Prostate Cancer
Official Title
Phase II Trial of Oral Colchicine in Men With Castrate-Resistant Prostate Cancer Who Have Failed Taxotere-Based Chemotherapy
Study Type
Interventional
2. Study Status
Record Verification Date
September 2013
Overall Recruitment Status
Withdrawn
Why Stopped
Due to funding
Study Start Date
May 2013 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
August 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Milton S. Hershey Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
oral colchicine, castrate-resistant prostate cancer, failed taxotere based chemotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single arm
Arm Type
Experimental
Arm Description
Colchicine 0.5 mg BID x 21 days
Intervention Type
Drug
Intervention Name(s)
Colchicine
Other Intervention Name(s)
Colcrys
Intervention Description
Colchicine 0.6 mg bid to a maximum of 1.2 mg bid
Primary Outcome Measure Information:
Title
PSA Response rate
Description
Determine the PSA response rate to continuous low dose oral colchicine
Time Frame
63 days (3 cycles of treatment)
Secondary Outcome Measure Information:
Title
Response rate
Description
Determine the progression free survival
Time Frame
63 days (3 cycles)
Title
Toxicity grading
Description
Determine the safety and tolerability of continuous low dose oral colchicine
Time Frame
One year
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph J Drabick, MD
Organizational Affiliation
Milton S. Hershey Medical Center
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Oral Colchicine in Men With Castrate Resistant Prostate Cancer
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