NCT00821912

TaxXel: Taxotere and Xeloda in Esophageal Cancer

A Phase I/II Study on the Treatment With Taxotere in Combination With Xeloda in Patients With Metastatic Oesophageal Cancer or Cancer in the Cardia Region

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 93 (actual)
• Sponsor: Karolinska University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cancer of the Esophagus
• Gastric Cardia Carcinoma

Interventions

Type	Name	Description
DRUG	Docetaxel	30 mg/m2, administered as a 30 min. i.v. infusion on cycle day 1, 8 and 15 or cycle day 1 and 8 in an alternating 3 weekly schedule
DRUG	Capecitabine	1650 mg/m2 /day orally b.i.d., day 1-14 every 3 weeks.

Timeline

• Start date: 2006-03-01
• Primary completion: 2012-09-01
• Completion: 2013-09-01
• First posted: 2009-01-14
• Last updated: 2012-02-28

Locations

10 sites across 2 countries: Norway, Sweden