Efavirenz in Treating Patients With Metastatic Prostate Cancer

Prostate Cancer Clinical Trial

— FAVE  

Official title:

A Phase II Trial to Assess the Efficacy of Efavirenz in Metastatic Patients With Androgen-independent Prostate Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00964002
• Other study ID #: CDR0000641767
• Secondary ID: IB-FAVEIB 2008-2
• Status: Completed
• Phase: Phase 2
• Start date: May 2008
• Est. completion date: April 8, 2014

Study information

• Verified date: November 2021
• Source: Institut Bergonié
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: April 8, 2014
• Est. primary completion date: September 19, 2011
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• efavirenz

Locations

Country	Name	City	State
France	Institut Bergonie	Bordeaux

Sponsors (1)

Lead Sponsor	Collaborator
Institut Bergonié

Country where clinical trial is conducted

France, 

References & Publications (1)

Houédé 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. On — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Without Prostate-specific Antigen Progression at 3 Months	Prostate-specific antigen (PSA) non-progression rate is defined as the rate of patients with the absence of PSA progression.; PSA progression is defined as follows : In patients whose PSA has not decreased, progressive disease is a 25% increase over the baseline (on-study) and an increase in the absolute-value PSA level by at least 5 ng/mL, which is confirmed by a second value.; In patients whose PSA has decreased but has not reached response criteria, progressive disease would be considered to have occurred when PSA increases 25% over the nadir, provided that the increase is a minimum of 5 ng/mL and is confirmed.; For the 3-month evaluation, patients who died within the 3 first months will be considered as progressions.; PSA assessment is to be performed every 28 days in the first 6 months after inclusion then every 3 months until progression or end of treatment. PSA assessment to establish eligibility is to be obtained from the same local laboratory using the same PSA assay.	3 months
Secondary	Percentage of Participants Without Prostate-specific Antigen Progression at 6 Months	Prostate-specific antigen (PSA) non-progression rate is defined as the rate of patients with the absence of PSA progression.; PSA progression is defined as follows : In patients whose PSA has not decreased, progressive disease is a 25% increase over the baseline (on-study) and an increase in the absolute-value PSA level by at least 5 ng/mL, which is confirmed by a second value.; In patients whose PSA has decreased but has not reached response criteria, progressive disease would be considered to have occurred when PSA increases 25% over the nadir, provided that the increase is a minimum of 5 ng/mL and is confirmed.; For the 6-month evaluation, patients who died within the 6 first months will be considered as progressions.; PSA assessment is to be performed every 28 days in the first 6 months after inclusion then every 3 months until progression or end of treatment. PSA assessment to establish eligibility is to be obtained from the same local laboratory using the same PSA assay.	6 months