Efavirenz as Second-Line Therapy in Treating Patients With Metastatic Pancreatic Cancer
- Conditions
- Pancreatic Cancer
- Registration Number
- NCT00964171
- Lead Sponsor
- Institut Bergonié
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 72
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Non-morphological progression as defined by RECIST criteria
- Secondary Outcome Measures
Name Time Method Non-biological progression, defined as 2-month CA 19-9 concentration < 1.5 times the baseline CA 19-9 concentration Quality of life Overall survival Progression-free survival Event-free survival Tolerability and safety as assessed by NCI CTCAE v 3.0
Trial Locations
- Locations (1)
Institut Bergonie
🇫🇷Bordeaux, France