TaxXel: Taxotere and Xeloda in Esophageal Cancer

Karolinska University Hospital

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Cancer of the Esophagus; Gastric Cardia Carcinoma

Treatments: Drug: Docetaxel; Drug: Capecitabine

Study type: Interventional

Funder types: Other

Identifiers

NCT00821912

TaxXel

Details and patient eligibility

About

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.

Enrollment: 93 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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93 participants in 1 patient group

Taxotere Xeloda

Experimental group

Description:

Taxotere i.v. infusion on cycle day 1, 8 and 15 or cycle day 1 and 8 in an alternating 3 weekly schedule. Xeloda orally day 1-14 every 3 weeks.

Treatment:

Drug: Capecitabine

Drug: Docetaxel