A Phase II Trial to Assess the Efficacy of Efavirenz in Metastatic Patients With Androgen-independent Prostate Cancer
18 Years
N/A
Male
Prostate Cancer
Trial Information
A Phase II Trial to Assess the Efficacy of Efavirenz in Metastatic Patients With Androgen-independent Prostate Cancer
OBJECTIVES:
Primary
- To assess the effect of efavirenz on the non-PSA progression rate at 3 months in
patients with castration-refractory metastatic prostate cancer.
Secondary
- To assess the effect of efavirenz on the PSA response at 3 months.
- To assess the effect of efavirenz on overall survival.
- To assess the effect of efavirenz on PSA progression-free survival.
- To assess the effect of efavirenz on symptomatic progression-free survival.
- To assess the tolerability and safety profile of efavirenz.
OUTLINE: This is a multicenter study.
Patients receive oral efavirenz once daily in the absence of disease progression or
unacceptable toxicity.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed prostate cancer
- Metastatic disease
- Castration-refractory disease
- No clinical symptoms related to disease progression
PATIENT CHARACTERISTICS:
- WHO performance status 0-2
PRIOR CONCURRENT THERAPY:
- Not specified
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Non-PSA progression rate at 3 months
Safety Issue:
No
Principal Investigator
Nadine Houede
Investigator Role:
Principal Investigator
Investigator Affiliation:
Institut Bergonié
Authority:
Unspecified
Study ID:
CDR0000641767
NCT ID:
NCT00964002
Start Date:
May 2008
Completion Date:
Related Keywords:
- Prostate Cancer
- recurrent prostate cancer
- stage IV prostate cancer
- Prostatic Neoplasms
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