Prostate CancerPhase 2NCT01481233
Oral Colchicine in Men With Castrate Resistant Prostate Cancer
A Phase 2 study testing Colchicine in people with Prostate Cancer, run by Milton S. Hershey Medical Center.
Trial summary
The purpose of this study is to determine the prostate specific antigen response to continuous low dose oral colchicine. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Colchicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- May 2013to Aug 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Bilirubin > 2 ULN
- AST > 2 x ULN
- Concurrent use of CYP3A4 inhibitors which may increase drug levels and toxicity
About this study
Official title: Phase II Trial of Oral Colchicine in Men With Castrate-Resistant Prostate Cancer Who Have Failed Taxotere-Based Chemotherapy
The purpose of this study is to determine the prostate specific antigen response to continuous low dose oral colchicine.
Read the 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.
- Conditions
- Prostate Cancer
- Being tested
- Colchicine
- Keywords
- oral colchicine, castrate-resistant prostate cancer, failed taxotere based chemotherapy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ColchicineDrug
Also called Colcrys
Colchicine 0.6 mg bid to a maximum of 1.2 mg bid
| Study group | Role | What they receive |
|---|---|---|
| Single arm | Experimental | Colchicine 0.5 mg BID x 21 days Receives: Drug: Colchicine |
What is being measured
The primary outcome is the main question the study is designed to answer.
PSA Response rate
Determine the PSA response rate to continuous low dose oral colchicine
Measured: 63 days (3 cycles of treatment)
Secondary outcomes (2)
Response rate
Determine the progression free survival
Measured: 63 days (3 cycles)
Toxicity grading
Determine the safety and tolerability of continuous low dose oral colchicine
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2011 (estimated)
- Study startMay 2013
- Primary completionAug 2013
- Study completionAug 2013
Why it stopped: Due to funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Milton S. Hershey Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joseph Drabick, Milton S. Hershey Medical Center
- Investigators
- Joseph J Drabick, MD, Principal investigator, Milton S. Hershey Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01481233
- Sponsor's protocol ID
- PSHCI 09-023
- Status last verified
- Sep 2013
- First submitted
- 11 Nov 2011
- Last updated
- 27 Sep 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of Oral Colchicine in Men With Castrate-Resistant Prostate Cancer Who Have Failed Taxotere-Based Chemotherapy
- ClinicalTrials.gov ID
- NCT01481233
- Acronym / sponsor ID
- PSHCI 09-023
- Conditions
- Prostate Cancer
- Keywords
- oral colchicine, castrate-resistant prostate cancer, failed taxotere based chemotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Due to funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 29 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm | Experimental | Drug: ColchicineColchicine 0.5 mg BID x 21 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- Inability to provide informed consent
- Hypersensitivity to colchicine
- Severe renal, gastrointestinal or hepatic disorders
- Pre-existing blood dyscrasia
- PLT < 100K, ANC < 1000
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ColchicineAlso: ColcrysColchicine 0.6 mg bid to a maximum of 1.2 mg bid | Drug | Single arm |
Primary outcome
PSA Response rate
Time frame: 63 days (3 cycles of treatment)
Determine the PSA response rate to continuous low dose oral colchicine
2 secondary outcomes
Response rate
Time frame: 63 days (3 cycles)
Toxicity grading
Time frame: One year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph J Drabick, MD principal investigator
Milton S. Hershey Medical Center
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Colchicine in people with Prostate Cancer, run by Milton S. Hershey Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 27 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PSA Response rate (time frame: 63 days (3 cycles of treatment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2013.