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

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institut Bergonié
• Treatments: Efavirenz

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)