Efavirenz in Treating Patients With Metastatic Prostate Cancer
Recruitment status was: Recruiting
RATIONALE: Efavirenz may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase II trial is studying how well efavirenz works in treating patients with metastatic prostate cancer.
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Trial to Assess the Efficacy of Efavirenz in Metastatic Patients With Androgen-independent Prostate Cancer|
- Non-PSA progression rate at 3 months
- PSA response rate at 3 months
- Overall survival
- PSA progression-free survival (PFS)
- Symptomatic PFS
- LINE 1 methylation level at baseline and 3 months
- Efavirenz blood concentration at 1 and 3 months
- Safety and tolerability as assessed by the incidence and type of adverse events according to NCI CTCAE, clinically significant laboratory abnormalities, and vital signs
|Study Start Date:||May 2008|
|Estimated Primary Completion Date:||December 2009 (Final data collection date for primary outcome measure)|
- To assess the effect of efavirenz on the non-PSA progression rate at 3 months in patients with castration-refractory metastatic prostate cancer.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00964002
|Bordeaux, France, 33076|
|Principal Investigator:||Nadine Houede||Institut Bergonié|