drugset / Trial / NCT01234051

Docetaxel and Oxaliplatin Combination With Locally Advanced or Metastatic Biliary Tract Cancer

NCT01234051 ↗

Phase 2 Unknown 53 enrolled Korean South West Oncology Group
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

EvaluationDrugModalityDoseRoute
Subject Docetaxel Small molecule 35 mg/m2 Intravenous
Subject Oxaliplatin Small molecule 100 mg/m2 Intravenous

Indications