drugset / Trial / NCT00714246
Bortezomib (PS-341) in Combination With Carboplatin and Docetaxel for Patients With Advanced Non-Small Cell Lung Cancer
Non-randomizedSequentialOpen-labelTreatment
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.
Timeline
- Start
- 2008-10
- Primary completion
- 2013-05
- Completion
- 2013-05
Outcome
Outcome not reported
Stopped (Enrollment): “Low accrual”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bortezomib | Small molecule | 0.7 mg/m2 | — |
| Subject | Bortezomib | Small molecule | 1 mg/m2 | — |
| Subject | Bortezomib | Small molecule | 1.3 mg/m2 | — |
| Subject | Carboplatin | Small molecule | 5 unknown | — |
| Subject | Carboplatin | Small molecule | 6 unknown | — |
| Subject | Docetaxel | Small molecule | 60 mg/m2 | — |
| Subject | Docetaxel | Small molecule | 75 mg/m2 | — |