A Phase II Trial to Assess the Efficacy of Efavirenz as Second-line Monotherapy for the Treatment of Advanced Pancreatic Adenocarcinomas.
- 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.
- 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
Patients complete quality-of-life questionnaires using the QLQ-C30 at baseline and at 2 and
After completion of study therapy patients are followed up every 2 months.
Masking: Open Label, Primary Purpose: Treatment
Non-morphological progression as defined by RECIST criteria
Marianne Fonck, MD