Efavirenz in Treating Patients With Metastatic Prostate Cancer

NCT ID: NCT00964002

Last Updated: 2022-05-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 61 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-05-31
• Study Completion Date: 2014-04-08

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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Efavirenz

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).

Group Type: EXPERIMENTAL

efavirenz

Intervention Type: DRUG

Interventions

efavirenz

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Institut Bergonié

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nadine Houede

Role: PRINCIPAL_INVESTIGATOR

Institut Bergonié

Locations

Institut Bergonie

Bordeaux, , France

Countries

France

References

Houede N, Pulido M, Mourey L, Joly F, Ferrero JM, Bellera C, Priou F, Lalet C, Laroche-Clary A, Raffin MC, Ichas F, Puech A, Piazza PV. A phase II trial evaluating the efficacy and safety of efavirenz in metastatic castration-resistant prostate cancer. Oncologist. 2014 Dec;19(12):1227-8. doi: 10.1634/theoncologist.2014-0345. Epub 2014 Oct 29.

Reference Type: RESULT

PMID: 25355844 (View on PubMed)

Other Identifiers

IB-FAVE

Identifier Type: -

Identifier Source: secondary_id

IB 2008-23

Identifier Type: -

Identifier Source: secondary_id

INCA-RECF0889

Identifier Type: -

Identifier Source: secondary_id

EUDRACT-2008-002730-30

Identifier Type: -

Identifier Source: secondary_id

CDR0000641767

Identifier Type: -

Identifier Source: org_study_id