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

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)