drugset / Trial / NCT00209690

Phase I/II Study of TPF as First-line Chemotherapy in Patients With Metastatic Esophageal Cancer.

NCT00209690

Non-randomizedSingle-groupOpen-labelTreatment

Summary

A phase I/II study is conducted to determine the maximum-tolerated dose (MTD), dose-limiting toxicity (DLT), and efficacy of a combination chemotherapy using docetaxel, cisplatin and 5-fluorouracil (TPF) in untreated patients with metastatic esophageal cancer. The usefulness of the this regimen is evaluated by response rate, median survival time, and progression free survival.

Timeline

Start
2003-10
Primary completion
2009-12
Completion
2010-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Cisplatin Other / unclassified 15 mg/m2 Intravenous
Subject Docetaxel Small molecule Intravenous
Subject fluorouracil Small molecule 800 mg/m2 Intravenous

Indications