Prostate Cancer
Conditions
Keywords
oral colchicine, castrate-resistant prostate cancer, failed taxotere based chemotherapy
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.
Interventions
DRUGColchicine
Colchicine 0.6 mg bid to a maximum of 1.2 mg bid
Sponsors
Milton S. Hershey Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PSA Response rate | 63 days (3 cycles of treatment) | Determine the PSA response rate to continuous low dose oral colchicine |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Response rate | 63 days (3 cycles) | Determine the progression free survival |
| Toxicity grading | One year | Determine the safety and tolerability of continuous low dose oral colchicine |
Outcome results
None listed