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

NCT00964171 | Completed Phase 2 Results

• 5 other identifiers: CDR0000641759IB-PANTERIB 2008-33INCA-RECF0888EUDRACT-2008-004273-18
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Cancer

Keywords

adenocarcinoma of the pancreas; recurrent pancreatic cancer; stage IV pancreatic cancer

Outcome Measures

Primary Outcomes (1)

• Percentage of Patients in Non-progression at 2 Months

  Non-progression is defined as partial response, complete response or stable disease according to RECIST V1.0. Complete response is defined as the disappearance of all target lesions and partial response is defined as at least a 30% decrease in the sum of the longest diameters (SLD) of target lesions, taking as reference the baseline SLD (RECIST V1.0.).Stable disease is defined as no decrease or increase sufficient to qualify as partial response or progression with reference to SLD since the start of treatment. Radiologic assessment was carried out every 8 weeks.

  2 months

Secondary Outcomes (6)

• Percentage of Patients in Non-progression at 4 Months

  4 months

• Percentage of Patients in Non-biological Progression at 2 Months

  2 months

• Overall Survival

  Through Database Cutoff Date of 06-July-2011 ( median follow-up time of 397 days)

• Event-free Survival

  Through Database Cutoff Date of 06-July-2011 ( median follow-up time of 397 days)

• Progression-free Survival

  Through Database Cutoff Date of 06-July-2011 ( median follow-up time of 397 days)

Study Arms (1)

Efavirenz

OTHER

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).

Drug: Efavirenz 600mg

Interventions

Efavirenz 600mg DRUG

Efavirenz

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Institut Bergonié: lead

Study Sites (1)

Institut Bergonie

Bordeaux, 33076, France

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

efavirenz

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Dr Marianne Fonck
• Organization: Institut Bergonié

m.fonck@bordeaux.unicancer.fr

05.56.33.32.42

Study Officials

• Marianne Fonck, MD

  Institut Bergonié

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2009
• First Posted: August 24, 2009
• Study Start: August 1, 2008
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: August 28, 2025
• Results First Posted: August 28, 2025

Record last verified: 2025-08

Locations

FR (1)