Efavirenz as Second-Line Therapy in Treating Patients With Metastatic Pancreatic Cancer
Recruitment status was: Recruiting
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.
Procedure: quality-of-life assessment
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Trial to Assess the Efficacy of Efavirenz as Second-line Monotherapy for the Treatment of Advanced Pancreatic Adenocarcinomas.|
- Non-morphological progression as defined by RECIST criteria [ Designated as safety issue: No ]
- Non-biological progression, defined as 2-month CA 19-9 concentration < 1.5 times the baseline CA 19-9 concentration [ Designated as safety issue: No ]
- Quality of life [ Designated as safety issue: No ]
- Overall survival [ Designated as safety issue: No ]
- Progression-free survival [ Designated as safety issue: No ]
- Event-free survival [ Designated as safety issue: No ]
- Tolerability and safety as assessed by NCI CTCAE v 3.0 [ Designated as safety issue: Yes ]
|Study Start Date:||August 2008|
|Estimated Primary Completion Date:||December 2010 (Final data collection date for primary outcome measure)|
- 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 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00964171
|Bordeaux, France, 33076|
|Principal Investigator:||Marianne Fonck, MD||Institut Bergonié|