drugset / Trial / NCT00043823
Avastin and Tarceva for Locally Advanced or Metastatic Non-Squamous Non-Small-Cell Lung Cancer
Phase 1/2
Completed
41 enrolled
M.D. Anderson Cancer Center
Genentech, Inc. · collabVanderbilt-Ingram Cancer Center · collab
NaSingle-groupOpen-labelTreatment
Summary
Primary Objectives: 1. (Phase I) To establish the maximum tolerated dose and dose-limiting toxicities of the combination of OSI-774 (Tarceva™) and rhuMAb VEGF (Avastin™) in patients with advanced Non-small-cell lung carcinoma (NSCLC). 2. (Phase II) To assess response rate and tolerability of the regimen at the dose level established in the phase I portion of this study. Secondary Objectives: 1. (Phase I and II) To evaluate the pharmacokinetic interaction between the combination. 2. (Phase I) To establish a phase II regimen of the OSI-774/ rhuMAb VEGF combination, for further study alone or in combination with cytotoxic chemotherapy.
Timeline
- Start
- 2002-08-01
- Primary completion
- 2006-05-15
- Completion
- 2006-05-15
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bevacizumab | Monoclonal antibody | 7.5 mg/kg | Intravenous |
| Subject | Erlotinib | Small molecule | 100 mg | Oral |