Informations générales (source: ClinicalTrials.gov)
A Phase II Trial to Assess the Efficacy of Efavirenz as Second-line Monotherapy for the Treatment of Advanced Pancreatic Adenocarcinomas.
Interventional
Phase 2
Institut Bergonié (Voir sur ClinicalTrials)
août 2008
29 juin 2024
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.
Etablissements
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| Institut Bergonie - 33076 - Bordeaux - France | Marianne Fonck, MD | Contact (sur clinicalTrials) | |||
Critères
Tous
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)
- 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)