This trial is active, not recruiting.

Conditions cancer of the esophagus, gastric cardia carcinoma
Treatments docetaxel, capecitabine
Phase phase 1/phase 2
Sponsor Karolinska University Hospital
Start date March 2006
End date September 2012
Trial size 93 participants
Trial identifier NCT00821912, TaxXel


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
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.
docetaxel Taxotere
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
capecitabine Xeloda
1650 mg/m2 /day orally b.i.d., day 1-14 every 3 weeks.

Primary Outcomes

Response rate
time frame:

Secondary Outcomes

CT scan
time frame: Every 9 weeks
Toxicity assessment
time frame: Every three weeks
Quality of life
time frame: Every three weeks

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

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
Principal investigator Signe Friesland, MD, PhD
Trial information was received from ClinicalTrials.gov and was last updated in February 2012.
Information provided to ClinicalTrials.gov by Karolinska University Hospital.