NCT00964171

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Institut Bergonié · Academic / Other
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	Efavirenz 600mg

Timeline

• Start date: 2008-08-01
• Primary completion: 2010-07-01
• Completion: 2010-07-01
• First posted: 2009-08-24
• Last updated: 2025-08-28
• Results posted: 2025-08-28

Locations

1 site across 1 country: France