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Efavirenz as Second-Line Therapy in Treating Patients With Metastatic Pancreatic Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00964171
Recruitment Status : Unknown
Verified April 2010 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
First Posted : August 24, 2009
Last Update Posted : April 7, 2010
Information provided by:
National Cancer Institute (NCI)

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 as second-line therapy in treating patients with metastatic pancreatic cancer.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Drug: efavirenz Procedure: quality-of-life assessment Phase 2

Detailed Description:



  • Evaluate the efficacy of efavirenz as second-line monotherapy, in terms of non-morphological progression at 2 months, in patients with metastatic adenocarcinoma of the pancreas.


  • Evaluate non-morphological progression in these patients at 4 months.
  • Evaluate non-biological progression in these patients at 2 and 4 months.
  • Evaluate the quality of life of these patients at 2 and 4 months.
  • Evaluate the overall, progression-free, and event-free survival of these patients.
  • Evaluate the tolerability and safety profile of efavirenz in these patients.

OUTLINE: This is a multicenter study.

Patients receive oral efavirenz once daily in the absence of disease progression or unacceptable toxicity.

Patients complete quality-of-life questionnaires using the QLQ-C30 at baseline and at 2 and 4 months.

After completion of study therapy patients are followed up every 2 months.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial to Assess the Efficacy of Efavirenz as Second-line Monotherapy for the Treatment of Advanced Pancreatic Adenocarcinomas.
Study Start Date : August 2008
Estimated Primary Completion Date : December 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Efavirenz
U.S. FDA Resources

Primary Outcome Measures :
  1. Non-morphological progression as defined by RECIST criteria

Secondary Outcome Measures :
  1. Non-biological progression, defined as 2-month CA 19-9 concentration < 1.5 times the baseline CA 19-9 concentration
  2. Quality of life
  3. Overall survival
  4. Progression-free survival
  5. Event-free survival
  6. Tolerability and safety as assessed by NCI CTCAE v 3.0

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed adenocarcinoma of the pancreas

    • No other histological types
  • Radiologically confirmed metastatic disease in a non-irradiated area
  • Measurable disease according to RECIST criteria
  • Must have exhausted first-line gemcitabine hydrochloride chemotherapy
  • No CNS metastases


  • WHO performance status (PS) 0-2 OR Karnofsky PS 70-100%
  • ANC ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Hemoglobin ≥ 10 g/dL
  • Creatinine ≤ 1.25 times upper limit of normal
  • Alkaline phosphatase < 5 times normal
  • Bilirubin < 3 times normal
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Has French Social Security in compliance with the French law relating to biomedical research
  • Able to comply with study treatment and follow-up
  • No severe renal failure
  • No severe hepatic impairment
  • No known hypersensitivity to the study drug and its excipients
  • No depression with a total score of ≥ 13 on the Hospital Anxiety and Depression (HAD) scale
  • No active diarrhea that may affect the ability to absorb the study drug
  • No other cancer within the past 5 years except carcinoma in situ of the cervix or basal cell carcinoma of the skin
  • No geographical, psychiatric, social, or psychological reason that would preclude compliance with study procedures


  • Recovered from all prior anticancer therapy
  • More than 30 days since prior investigational drugs and/or participation in a clinical trial
  • Prior adjuvant chemotherapy (one-line only) and/or radiotherapy allowed
  • No prior enrollment on this study
  • No prior treatment acting on the signal transduction pathway
  • No prior yellow fever vaccine
  • No other concurrent second-line therapy
  • No concurrent terfenadine, astemizole, cisapride, midazolam, triazolam, pimozide, bepridil, rye alkaloids, voriconazole, or St. John wort (Hypericum perforatum)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00964171

Institut Bergonie Recruiting
Bordeaux, France, 33076
Contact: Marianne Fonck, MD    33-5-5633-3242      
Sponsors and Collaborators
Institut Bergonié
Principal Investigator: Marianne Fonck, MD Institut Bergonié

ClinicalTrials.gov Identifier: NCT00964171     History of Changes
Other Study ID Numbers: CDR0000641759
IB 2008-33
First Posted: August 24, 2009    Key Record Dates
Last Update Posted: April 7, 2010
Last Verified: April 2010

Keywords provided by National Cancer Institute (NCI):
adenocarcinoma of the pancreas
recurrent pancreatic cancer
stage IV pancreatic cancer

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Cytochrome P-450 CYP2C19 Inhibitors
Cytochrome P-450 CYP2B6 Inducers
Cytochrome P-450 Enzyme Inducers
Cytochrome P-450 CYP3A Inducers