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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.


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Pancreatic Cancer

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Trial Information

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


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.

Inclusion 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)

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Non-morphological progression as defined by RECIST criteria

Safety Issue:

No

Principal Investigator

Marianne Fonck, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Institut Bergonié

Authority:

Unspecified

Study ID:

CDR0000641759

NCT ID:

NCT00964171

Start Date:

August 2008

Completion Date:

Related Keywords:

  • Pancreatic Cancer
  • adenocarcinoma of the pancreas
  • recurrent pancreatic cancer
  • stage IV pancreatic cancer
  • Adenocarcinoma
  • Pancreatic Neoplasms

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