Efavirenz as Second-Line Therapy in Treating Patients With Metastatic Pancreatic Cancer
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|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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|