drugset / Trial / NCT01234051
Docetaxel and Oxaliplatin Combination With Locally Advanced or Metastatic Biliary Tract Cancer
NaSingle-groupOpen-labelTreatment
Summary
1. Goals * The primary goal of this phase II trial is to: evaluate the response rate of combination chemotherapy with docetaxel and oxaliplatin in patients with locally advanced or metastatic BTC as first-line therapy Secondary goals are to:evaluate the treatment-related toxicities of this combination, investigate progression-free survival (PFS) and overall survival (OS) in this population 2. Design The proposed clinical trial is an open label, non-comparative, multicenter phase II trial according to the two stage testing design by Simon.22
Timeline
- Start
- 2010-11
- Primary completion
- 2013-12
- Completion
- 2013-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Docetaxel | Small molecule | 35 mg/m2 | Intravenous |
| Subject | Oxaliplatin | Small molecule | 100 mg/m2 | Intravenous |