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

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Phase II Trial to Assess the Efficacy of Efavirenz as Second-line Monotherapy for the Treatment of Advanced Pancreatic Adenocarcinomas.

Conditions
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Pancreatic Cancer

Intervention / Treatment
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* Drug: efavirenz
* Procedure: quality-of-life assessment


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: efavirenz|nan|
|Procedure: quality-of-life assessment|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Non-morphological progression as defined by RECIST criteria |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Non-biological progression, defined as 2-month CA 19-9 concentration < 1.5 times the baseline CA 19-9 concentration |  |  | 
| Quality of life |  |  | 
| Overall survival |  |  | 
| Progression-free survival |  |  | 
| Event-free survival |  |  | 
| Tolerability and safety as assessed by NCI CTCAE v 3.0 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adenocarcinoma of the pancreas, recurrent pancreatic cancer, stage IV pancreatic cancer