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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2010 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00964171
First received: August 21, 2009
Last updated: April 6, 2010
Last verified: April 2010
  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 as second-line therapy in treating patients with metastatic pancreatic cancer.


Condition Intervention Phase
Pancreatic Cancer
Drug: efavirenz
Procedure: quality-of-life assessment
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 as Second-line Monotherapy for the Treatment of Advanced Pancreatic Adenocarcinomas.

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Non-morphological progression as defined by RECIST criteria [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Non-biological progression, defined as 2-month CA 19-9 concentration < 1.5 times the baseline CA 19-9 concentration [ Designated as safety issue: No ]
  • Quality of life [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • Progression-free survival [ Designated as safety issue: No ]
  • Event-free survival [ Designated as safety issue: No ]
  • Tolerability and safety as assessed by NCI CTCAE v 3.0 [ Designated as safety issue: Yes ]

Estimated Enrollment: 72
Study Start Date: August 2008
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • 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.

Secondary

  • 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

  • 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

PRIOR CONCURRENT THERAPY:

  • 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)
  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: NCT00964171

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

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00964171     History of Changes
Other Study ID Numbers: CDR0000641759, IB-PANTER, IB 2008-33, INCA-RECF0888, EUDRACT-2008-004273-18
Study First Received: August 21, 2009
Last Updated: April 6, 2010
Health Authority: Unspecified

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

Additional relevant MeSH terms:
Adenocarcinoma
Pancreatic Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Efavirenz
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents

ClinicalTrials.gov processed this record on July 24, 2014