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

Conditions: Pancreatic Cancer

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.

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 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)

Keywords: adenocarcinoma of the pancreas recurrent pancreatic cancer stage iv pancreatic cancer