Efavirenz as Second-Line Therapy in Treating Patients With Metastatic Pancreatic Cancer
|ClinicalTrials.gov Identifier: NCT00964171|
Recruitment Status : Unknown
Verified April 2010 by National Cancer Institute (NCI).
Recruitment status was: Recruiting
First Posted : August 24, 2009
Last Update Posted : April 7, 2010
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.
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Cancer||Drug: efavirenz Procedure: quality-of-life assessment||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||72 participants|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Trial to Assess the Efficacy of Efavirenz as Second-line Monotherapy for the Treatment of Advanced Pancreatic Adenocarcinomas.|
|Study Start Date :||August 2008|
|Estimated Primary Completion Date :||December 2010|
- Non-morphological progression as defined by RECIST criteria
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00964171
|Bordeaux, France, 33076|
|Contact: Marianne Fonck, MD 33-5-5633-3242|
|Principal Investigator:||Marianne Fonck, MD||Institut Bergonié|