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
18 Years
N/A
Both
Cancer of the Esophagus, Gastric Cardia Carcinoma
Trial Information
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
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.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Response rate
Outcome Description:
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.
Safety Issue:
No
Principal Investigator
Signe Friesland, MD, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Karolinska University Hospital
Authority:
Sweden: Medical Products Agency
Study ID:
TaxXel
NCT ID:
NCT00821912
Start Date:
March 2006
Completion Date:
September 2013
Related Keywords:
- Cancer of the Esophagus
- Gastric Cardia Carcinoma
- Carcinoma
- Esophageal Neoplasms
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