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Completed

NCT Number: NCT00964171

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

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.

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Key information

Conditions

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

Age range

18 year–120 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Institut Bergonie

Bordeaux, 33076, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Efavirenz 600mg

Drug

Primary outcomes

  1. Percentage of Patients in Non-progression at 2 Months

    Time frame: 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.

Secondary outcomes

  1. Percentage of Patients in Non-progression at 4 Months

    Time frame: 4 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. Percentage of Patients in Non-biological Progression at 2 Months

    Time frame: 2 months

    Non-biological progression was assessed using CA 19-9 every 28 days until end of treatment, and was defined as a 2-month CA19.9 concentration lower than 1.5 times the baseline CA 19-9 concentration.

  3. Overall Survival

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

    OS was was defined as the time from the inclusion to death due to any cause. Participants without documented death were censored at the date of the last follow-up or last patient contact. The OS was calculated using the product-limit (Kaplan-Meier) method for censored data.

  4. Event-free Survival

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

    Event-free survival (EFS) was defined as the delay between trial inclusion and the first of the following events: progression (biological or morphological), death, treatment interruption due to toxicity, initiation of another treatment. Morphological progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Biological progression is defined as a confirmed increase in CA 19-9 concentration to more than 1.5 times the baseline value, sustained over two consecutive monthly assessments.

    Patients without any of the aforementioned events at the time of the statistical analysis will be censored at the time they were last known to be event-free. The EFS was calculated using the product-limit (Kaplan-Meier) method for censored data.

  5. Progression-free Survival

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

    Progression was defined as morphological or biological progression. Progression-free survival was defined as the delay between trial inclusion and progression (morphological or biological) or death for any reason. Morphological progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Biological progression is defined as a confirmed increase in CA 19-9 concentration to more than 1.5 times the baseline value, sustained over two consecutive monthly assessments. Patients who have not progressed nor died at the time of the statistical analysis will be censored at the time they were last known to be progression-free. The EFS was calculated using the product-limit (Kaplan-Meier) method for censored data.

  6. Quality of Life Score

    Time frame: 2 months

    EORTC-QLQ-C30 is a cancer-specific instrument with 30 questions to evaluate quality of life. The first 28 use a 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much) assessing 5 functional scales (physical, role, emotional, cognitive, social), 3 symptom scales (fatigue, nausea/vomiting, pain), six single symptoms (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties), and two global health/QoL questions. Items 29 and 30 use a 7-point scale (1=very poor to 7=excellent).Scores are linearly transformed from 0 to 100 per EORTC guidelines. Higher scores mean better functioning or QoL for functional/global scales, but worse symptoms for symptom scales and items. Score ranges (0-100): higher Functional scores = better QoL; higher Symptom scores= worse QoL; Higher Global health score= better QoL.

Sponsors and collaborators

Lead sponsor

Institut Bergonié

Other

Registry information

Official study title

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

Acronym: PANTER

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Aug 24, 2009
Registry last updated
Aug 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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