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

Pancreatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00964171
• Other study ID #: CDR0000641759
• Secondary ID: IB-PANTERIB 2008
• Status: Recruiting
• Phase: Phase 2
• First received: August 21, 2009
• Last updated: April 6, 2010
• Start date: August 2008

Study information

• Verified date: April 2010
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unspecified
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• efavirenz

Procedure:
• quality-of-life assessment

Locations

Country	Name	City	State
France	Institut Bergonie	Bordeaux

Sponsors (1)

Lead Sponsor	Collaborator
Institut Bergonié

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Non-morphological progression as defined by RECIST criteria			No
Secondary	Non-biological progression, defined as 2-month CA 19-9 concentration < 1.5 times the baseline CA 19-9 concentration			No
Secondary	Quality of life			No
Secondary	Overall survival			No
Secondary	Progression-free survival			No
Secondary	Event-free survival			No
Secondary	Tolerability and safety as assessed by NCI CTCAE v 3.0			Yes