Back to resultsEfavirenz as Second-Line Therapy in Treating Patients With Metastatic Pancreatic Cancer
Primary Purpose
Pancreatic Cancer
Status
Unknown status
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
efavirenz
quality-of-life assessment
Sponsored by
About this trial
This is an interventional treatment trial for Pancreatic Cancer focused on measuring adenocarcinoma of the pancreas, recurrent pancreatic cancer, stage IV pancreatic cancer
Eligibility 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)
Sites / Locations
- Institut BergonieRecruiting
Outcomes
Primary Outcome Measures
Non-morphological progression as defined by RECIST criteria
Secondary Outcome Measures
Non-biological progression, defined as 2-month CA 19-9 concentration < 1.5 times the baseline CA 19-9 concentration
Quality of life
Overall survival
Progression-free survival
Event-free survival
Tolerability and safety as assessed by NCI CTCAE v 3.0
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00964171
Brief Title
Efavirenz as Second-Line Therapy in Treating Patients With Metastatic Pancreatic Cancer
Official Title
A Phase II Trial to Assess the Efficacy of Efavirenz as Second-line Monotherapy for the Treatment of Advanced Pancreatic Adenocarcinomas.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2010
Overall Recruitment Status
Unknown status
Study Start Date
August 2008 (undefined)
Primary Completion Date
December 2010 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Institut Bergonié
4. Oversight
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
Keywords
adenocarcinoma of the pancreas, recurrent pancreatic cancer, stage IV pancreatic cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)
Enrollment
72 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
efavirenz
Intervention Type
Procedure
Intervention Name(s)
quality-of-life assessment
Primary Outcome Measure Information:
Title
Non-morphological progression as defined by RECIST criteria
Secondary Outcome Measure Information:
Title
Non-biological progression, defined as 2-month CA 19-9 concentration < 1.5 times the baseline CA 19-9 concentration
Title
Quality of life
Title
Overall survival
Title
Progression-free survival
Title
Event-free survival
Title
Tolerability and safety as assessed by NCI CTCAE v 3.0
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marianne Fonck, MD
Organizational Affiliation
Institut Bergonié
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut Bergonie
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marianne Fonck, MD
Phone
33-5-5633-3242
12. IPD Sharing Statement
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Efavirenz as Second-Line Therapy in Treating Patients With Metastatic Pancreatic Cancer
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