Efavirenz as Second-Line Therapy in Treating Patients With Metastatic Pancreatic Cancer
Conditions
Pancreatic Cancer
Conditions: official terms
Pancreatic Neoplasms
Conditions: Keywords
adenocarcinoma of the pancreas, recurrent pancreatic cancer, stage IV pancreatic cancer
Study Type
Interventional
Study Phase
Phase 2
Study Design
Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: efavirenz Type: Drug
Name: quality-of-life assessment Type: Procedure
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
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)
Location
Institut Bergonie
Bordeaux, France
Status: Recruiting
Contact: Marianne Fonck, MD - 33-5-5633-3242
Start Date
August 2008
Sponsors
Institut Bergonié
Source
National Cancer Institute (NCI)
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page