TaxXel: Taxotere and Xeloda in Esophageal Cancer

• Status: Unknown status
• Trial end date: 2013-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Karolinska University Hospital
• Treatments: Capecitabine; Docetaxel

Criteria

Inclusion Criteria:

• Histologically confirmed squamous cell carcinoma or adenocarcinoma of the oesophagus or cardia.

• Inoperable metastatic disease

• Performance status (WHO) of 0-2

• Measurable disease.

• Adequate hematological, liver and renal function.

• Signed informed consent.

Exclusion Criteria:

• CNS metastases

• Symptomatic peripheral neuropathy equal to or greater than NCI grade 2.

• Other concomitant serious illness or medical condition.

• Past or current history of malignant neoplasm other than oesophageal carcinoma.

• <18 years of age. Pregnant or lactating patients.