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Bortezomib (PS-341) in Combination With Carboplatin and Docetaxel for Patients With Advanced Non-Small Cell Lung Cancer

Non Small Cell Lung Cancer Clinical Trial

Official title:
Phase I/II Study of Bortezomib (PS-341) in Combination With Carboplatin and Docetaxel for Patients With Advanced Non-Small Cell Lung Cancer

Clinical Trial Summary

This is a phase I/II study. The phase I portion of the study will determine the maximum tolerated dose of bortezomib when administered in combination with carboplatin & docetaxel and to determine the efficacy of the combination for patients with advanced NSCLC. Phase II will utilize the dosage determined in the Phase I and implement regimen to determine time to progression, overall survival, and changes in serum proteomics patterns before & after combination therapy.

Clinical Trial Description

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.

The trial was intended to be 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. However, the trial never moved past the phase I portion of the study and was terminated early. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00714246
Study type Interventional
Source Milton S. Hershey Medical Center
Contact
Status Terminated
Phase Phase 1
Start date October 2008
Completion date May 2013
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