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Efavirenz in Treating Patients With Metastatic Prostate Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00964002
First received: August 21, 2009
Last updated: September 4, 2009
Last verified: September 2009
  Purpose

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.


Condition Intervention Phase
Prostate Cancer
Drug: efavirenz
Phase 2

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Non-PSA progression rate at 3 months [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • PSA response rate at 3 months [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • PSA progression-free survival (PFS) [ Designated as safety issue: No ]
  • Symptomatic PFS [ Designated as safety issue: No ]
  • LINE 1 methylation level at baseline and 3 months [ Designated as safety issue: No ]
  • Efavirenz blood concentration at 1 and 3 months [ Designated as safety issue: No ]
  • Safety and tolerability as assessed by the incidence and type of adverse events according to NCI CTCAE, clinically significant laboratory abnormalities, and vital signs [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: May 2008
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • To assess the effect of efavirenz on the non-PSA progression rate at 3 months in patients with castration-refractory metastatic prostate cancer.

Secondary

  • 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00964002

Locations
France
Institut Bergonie Recruiting
Bordeaux, France, 33076
Contact: Nadine Houede    33-556-333-333    houede@bergonie.org   
Sponsors and Collaborators
Institut Bergonié
Investigators
Principal Investigator: Nadine Houede Institut Bergonié
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00964002     History of Changes
Other Study ID Numbers: CDR0000641767, IB-FAVE, IB 2008-23, INCA-RECF0889, EUDRACT-2008-002730-30
Study First Received: August 21, 2009
Last Updated: September 4, 2009
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
recurrent prostate cancer
stage IV prostate cancer

Additional relevant MeSH terms:
Prostatic Diseases
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Urogenital Neoplasms
Efavirenz
Anti-Infective Agents
Anti-Retroviral Agents
Antiviral Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014