drugset / Trial / NCT00411593
Phase I-II for Patients With Recurrent or Refractory Non-small Cell Lung Cancer (NSCLC)
Phase 1/2
Withdrawn
M.D. Anderson Cancer Center
Genentech, Inc. · collabMillennium Pharmaceuticals, Inc. · collab
NaSingle-groupOpen-labelTreatment
Summary
Primary Objective The primary objective of this phase I-II study is to evaluate: * Phase I: Assess the maximum tolerated dose (MTD) of bortezomib in a weekly schedule with bevacizumab given every 3 weeks. * Phase II: Using the MTD established in phase I, assess efficacy of the combination as indicated by progression-free survival. Secondary Objectives The secondary objectives of this study are to evaluate: * Response rates and duration of response * 1 year survival * Overall survival * Qualitative and quantitative toxicity * Circulating endothelial cells (CECs) prior to treatment, prior to cycle 2, and/or at the time of progression
Timeline
- Start
- 2006-11
- Primary completion
- 2007-05
- Completion
- 2007-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bevacizumab | Monoclonal antibody | 15 g/kg | Intravenous |
| Subject | Bortezomib | Small molecule | 1.6 mg/m2 | Intravenous |