NCT00714246

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

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

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Milton S. Hershey Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Non Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Bortezomib	Dose escalation using traditional Phase I - 3 x 3 design to establish MTD of bortezomib when administered in combination with carboplatin and docetaxel
DRUG	Carboplatin	Establish MTD of bortezomib when administered in combination with carboplatin and docetaxel
DRUG	Docetaxel	Establish MTD of bortezomib when administered in combination with carboplatin and docetaxel

Timeline

• Start date: 2008-10-01
• Primary completion: 2013-05-01
• Completion: 2013-05-01
• First posted: 2008-07-14
• Last updated: 2019-06-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study