drugset / Trial / NCT00140140
A Phase I/II Study of ABI-007 (Abraxane®, Nab®-Paclitaxel)and Vinorelbine in Patients With Stage IV (Metastatic) Breast Cancer
Non-randomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to: 1) determine the optimal tolerated dose of ABI-007 and vinorelbine, given concurrently on a weekly basis, in the absence of planned growth factor support with granulocyte colony-stimulating factor (G-CSF) (Patients with HER-2/neu positive disease may receive Herceptin, and 2) determine the optimal tolerated dose of ABI-007 and vinorelbine, given concurrently on a weekly basis, in the presence of planned growth factor support with G-CSF.
Timeline
- Start
- 2005-08
- Primary completion
- 2008-02
- Completion
- 2008-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Paclitaxel | Small molecule | 80 mg/m2 | Intravenous |
| Subject | Paclitaxel | Small molecule | 90 mg/m2 | Intravenous |
| Subject | Vinorelbine | Small molecule | 15 mg/m2 | Intravenous |
| Subject | Vinorelbine | Small molecule | 20 mg/m2 | Intravenous |
| Background | Trastuzumab | Monoclonal antibody | 2 mg/kg | Intravenous |