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

Institut Bergonié

Status and phase: Completed; Phase 2

Conditions: Pancreatic Cancer

Treatments: Drug: Efavirenz 600mg

Study type: Interventional

Funder types: Other

Identifiers

NCT00964171

EUDRACT-2008-004273-18

IB-PANTER

IB 2008-33

CDR0000641759

INCA-RECF0888

Details and patient eligibility

About

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.

Full 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.

Enrollment: 19 patients

Sex: All

Ages: 18 to 120 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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19 participants in 1 patient group

Efavirenz

Other group

Description:

Efavirenz will be provided by the sponsor as follows: capsule of efavirenz 200 mg. A bottle contains 90 capsules. Investigator will dispense efavirenz to the patients according to the dose adjustment. Each patient will receive efavirenz 600 mg/day until morphological progression. Study drug will be taken every day by oral route at bedtime and in fast condition (1-2 hours far from dinner).

Treatment:

Drug: Efavirenz 600mg