Clinical trial NCT00964171: Efavirenz as Second-Line Therapy in Treating Patients With Metastatic Pancreatic Cancer
Official title: A Phase II Trial to Assess the Efficacy of Efavirenz as Second-line Monotherapy for the Treatment of Advanced Pancreatic Adenocarcinomas.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Pancreatic Cancer
Keywords: adenocarcinoma of the pancreas
recurrent pancreatic cancer
stage IV pancreatic cancer
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2009-08-24
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief 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.

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)

Primary outcomes:
measure: Non-morphological progression as defined by RECIST criteria
Secondary outcomes:
measure: Non-biological progression, defined as 2-month CA 19-9 concentration < 1.5 times the baseline CA 19-9 concentration
measure: Quality of life
measure: Overall survival
measure: Progression-free survival
measure: Event-free survival
measure: Tolerability and safety as assessed by NCI CTCAE v 3.0
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Institut Bergonie
Study officials:
affiliation: Institut Bergonié
name: Marianne Fonck, MD
role: PRINCIPAL_INVESTIGATOR
References: