drugset / Trial / NCT00821912

TaxXel: Taxotere and Xeloda in Esophageal Cancer

NCT00821912 ↗

Phase 1/2 Unknown 93 enrolled Karolinska University Hospital
Non-randomizedSingle-groupOpen-labelTreatment

Summary

This is an open label, non-randomised, multicentre phase 1-2 study with a fixed dose of Taxotere in combination with Xeloda which is dose escalated during the first phase of the study (modified Fibonacci design) and fixed during the second phase. The primary objective of the phase 1 part is to define the dose recommended for the Phase II part of the study. The primary objective is to determine the response rate.

Timeline

Start
2006-03
Primary completion
2012-09
Completion
2013-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Capecitabine Small molecule 1650 mg/m2 Oral
Subject Docetaxel Small molecule 30 mg/m2 Intravenous