Efavirenz in Treating Patients With Metastatic Prostate Cancer (FAVE)

Institut Bergonié

Status and phase: Completed; Phase 2

Conditions: Prostate Cancer

Treatments: Drug: efavirenz

Study type: Interventional

Funder types: Other

Identifiers

NCT00964002

IB-FAVE

INCA-RECF0889

CDR0000641767

IB 2008-23

EUDRACT-2008-002730-30

Details and patient eligibility

About

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.

Full 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.

Enrollment: 61 patients

Sex: Male

Ages: 18 to 120 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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61 participants in 1 patient group

Efavirenz

Experimental group

Description:

Patients will receive efavirenz 600 mg daily as oral tablets at bedtime and in fast condition (1-2 hours far from dinner) until objective biological, radiological or clinical disease progression or study discontinuation (withdrawal of consent or when the patient meets one criterion for treatment discontinuation). Individual dose escalation will be possible: if biological progression occurs at month 3, dose could be increased to 1200 mg/day in asymptomatic and non radiological progression patients (by step of 200 mg every 15 days).

Treatment:

Drug: efavirenz