Spots Global Cancer Trial Database for Efavirenz as Second-Line Therapy in Treating Patients With Metastatic Pancreatic Cancer

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Trial Identification

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

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

Study ID: NCT00964171

Conditions

Pancreatic Cancer

Interventions

efavirenz

quality-of-life assessment

Study Description

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.

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.