TaxXel: Taxotere and Xeloda in Esophageal Cancer

Study Overview
=================
Brief 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.

Official Title
-----------------
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

Conditions
-----------------
Cancer of the Esophagus, Gastric Cardia Carcinoma

Intervention / Treatment
-----------------
* Drug: Docetaxel
* Drug: Capecitabine


Participation Criteria
=================
Eligibility 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Taxotere Xeloda<br>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. | Drug: Docetaxel<br>* 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<br>* Other names: Taxotere;Drug: Capecitabine<br>* 1650 mg/m2 /day orally b.i.d., day 1-14 every 3 weeks.<br>* Other names: Xeloda;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate | Response rate will be defined as the percentage of patients who achieve a complete response (CR) or partial response (PR). Duration of a CR or PR will be calculated from the time that measurement criteria are met for complete response or partial response until the first date that recurrent or progressive disease is objectively documented. |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CT scan |  | Every 9 weeks | 
| Toxicity assessment |  | Every three weeks | 
| Quality of life |  | Every three weeks |