Status:
COMPLETED
Efavirenz as Second-Line Therapy in Treating Patients With Metastatic Pancreatic Cancer
Lead Sponsor:
Institut Bergonié
Conditions:
Pancreatic Cancer
Eligibility:
All Genders
18-120 years
Phase:
PHASE2
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 therap...
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...
Eligibility Criteria
Inclusion
- 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)
Exclusion
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT00964171
Start Date
August 1 2008
End Date
July 1 2010
Last Update
August 28 2025
Active Locations (1)
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1
Institut Bergonie
Bordeaux, France, 33076