NCT01481233

Brief Summary

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

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started May 2013

Shorter than P25 for phase_2 prostate-cancer

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 11, 2011

Completed
18 days until next milestone

First Posted

Study publicly available on registry

November 29, 2011

Completed
1.4 years until next milestone

Study Start

First participant enrolled

May 1, 2013

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

September 27, 2013

Status Verified

September 1, 2013

Enrollment Period

3 months

First QC Date

November 11, 2011

Last Update Submit

September 26, 2013

Conditions

Prostate Cancer

Keywords

oral colchicinecastrate-resistant prostate cancerfailed taxotere based chemotherapy

Outcome Measures

Primary Outcomes (1)

  • PSA Response rate

    Determine the PSA response rate to continuous low dose oral colchicine

    63 days (3 cycles of treatment)

Secondary Outcomes (2)

  • Response rate

    63 days (3 cycles)

  • Toxicity grading

    One year

Study Arms (1)

Single arm

EXPERIMENTAL

Colchicine 0.5 mg BID x 21 days

Drug: Colchicine

Interventions

ColchicineDRUG

Colchicine 0.6 mg bid to a maximum of 1.2 mg bid

Also known as: Colcrys
Single arm

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Colchicine

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

AlkaloidsHeterocyclic Compounds

Study Officials

  • Joseph J Drabick, MD

    Milton S. Hershey Medical Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

November 11, 2011

First Posted

November 29, 2011

Study Start

May 1, 2013

Primary Completion

August 1, 2013

Study Completion

August 1, 2013

Last Updated

September 27, 2013

Record last verified: 2013-09