Lower Dose Chemotherapy Given More Frequent With Avastin to Treat Advanced Non-Squamous Non-Small Cell Lung Cancer
Summary
This study is being done to determine the overall progression-free survival (PFS) in patients with advanced or metastatic (Stage IIIB - pleural effusion/IV), non-squamous histology NSCLC treated with metronomic chemotherapy plus Avastin. Also, currently there are no defined markers that predict for clinical benefit to Avastin. Preliminary studies show that there are several observations that support the concept of metronomic chemotherapy with or without the combination of an anti-angiogenic agent. The metronomic chemotherapy with Avastin was shown to enhance the clinical endpoints of the study (response rate and progressive-free survival). Proof of metronomic scheduling requires the development of appropriate intermediate surrogate markers. Several markers will be assessed.
Timeline
- Start
- 2008-03
- Primary completion
- 2015-09
- Completion
- 2016-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bevacizumab | Monoclonal antibody | 10 mg/kg | Intravenous |
| Subject | Gemcitabine | Small molecule | 150 mg/m2 | Intravenous |
| Subject | Gemcitabine | Small molecule | 200 mg/m2 | Intravenous |
| Subject | Gemcitabine | Small molecule | 300 mg/m2 | Intravenous |
| Subject | Paclitaxel | Small molecule | 70 mg/m2 | Intravenous |
| Subject | Paclitaxel | Small molecule | 80 mg/m2 | Intravenous |