Spots Global Cancer Trial Database for Efavirenz in Treating Patients With Metastatic Prostate Cancer
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Trial Identification
Brief Title: Efavirenz in Treating Patients With Metastatic Prostate Cancer
Official Title: A Phase II Trial to Assess the Efficacy of Efavirenz in Metastatic Patients With Androgen-independent Prostate Cancer
Study ID: NCT00964002
Conditions
Interventions
Study Description
Brief Summary: 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.
Detailed Description: OBJECTIVES: Primary * To assess the effect of efavirenz on the PSA non-progression rate at 3 months in patients with castration-refractory metastatic prostate cancer. Secondary * To assess the effect of efavirenz on the PSA non-progression rate at 6 months. * To assess the effect of efavirenz on overall survival. * To assess the effect of efavirenz on PSA 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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Locations
Institut Bergonie, Bordeaux, , France
Contact Details
Name: Nadine Houede
Affiliation: Institut Bergonié
Role: PRINCIPAL_INVESTIGATOR
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