Phase I/II Study of Bortezomib (PS-341) in Combination With Carboplatin and Docetaxel for Patients With Advanced Non-Small Cell Lung Cancer
A chemotherapy efficacy plateau' has been reached for the treatment of patients with
advanced or metastatic non-small cell lung cancer. Platinum-based two-drug combination is
considered the current standard of care for the treatment of advanced NSCLC. There is a need
to develop novel regimens to improve the outcome for patients with advanced NSCLC. The
combination of carboplatin and docetaxel is effective for therapy of advanced NSCLC. This
combination results in improved survival and quality of life for patients with advanced
NSCLC. Docetaxel exhibits preclinical synergy with bortezomib. Hence we plan to perform a
phase I/II study to define the maximum tolerated dose of bortezomib that can be administered
in combination with docetaxel and carboplatin and subsequently evaluate the efficacy of the
regimen for patients with advanced NSCLC.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment
Determine maximum tolerated dose of bortezomib when administered in combination with carboplatin & docetaxel for treatment of patients with advanced NSCLC cancer. Determine the response rate of the combination for patients with advanced NSCLC.
Expected average of 2 years
No
Chandra P. Belani, MD
Principal Investigator
Penn State College of Medicine
United States: Food and Drug Administration
PSU 26983
NCT00714246
August 2008
August 2013
Name | Location |
---|---|
Penn State College of Medicine, Penn State Milton S. Hershey Medical Center | Hershey, Pennsylvania 17033 |