drugset
drugset / Trial / NCT00041470

Navelbine, Taxol, Herceptin and Neupogen in Stage IV Breast Cancer: A Phase I - II Trial

NCT00041470 ↗

Phase 1/2 Terminated 38 enrolled University of Washington Amgen · collabBristol-Myers Squibb · collabGlaxoSmithKline · collab
NaSingle-groupOpen-labelTreatment

Summary

The purposes of this are: * To determine the highest doses of Taxol and Navelbine that we can safely give to patients; * To determine what kind of side effects are caused by the combination of Taxol, Navelbine and G-CSF; * To determine whether the combination of Taxol, Navelbine and G-CSF is more effective than standard therapy in treating metastatic breast cancer and prolonging life;

Timeline

Start
2001-03
Primary completion
2008-08
Completion
2008-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Paclitaxel Small molecule 50 mg/m2 Intravenous
Subject Paclitaxel Small molecule 60 mg/m2 Intravenous
Subject Paclitaxel Small molecule 70 mg/m2 Intravenous
Subject Paclitaxel Small molecule 80 mg/m2 Intravenous
Subject Vinorelbine Small molecule 20 mg/m2 Intravenous
Subject Vinorelbine Small molecule 22.5 mg/m2 Intravenous
Subject Vinorelbine Small molecule 25 mg/m2 Intravenous
Subject Vinorelbine Small molecule 27.5 mg/m2 Intravenous
Background Trastuzumab Monoclonal antibody 2 mg/kg Intravenous
Background filgrastim Protein / enzyme biologic 5 ug/kg Subcutaneous

Indications

breast cancer