Status:
UNKNOWN
TaxXel: Taxotere and Xeloda in Esophageal Cancer
Lead Sponsor:
Karolinska University Hospital
Conditions:
Cancer of the Esophagus
Gastric Cardia Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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 Fibona...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2013
Estimated Enrollment :
93 Patients enrolled
Trial Details
Trial ID
NCT00821912
Start Date
March 1 2006
End Date
September 1 2013
Last Update
February 28 2012
Active Locations (10)
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1
Haukeland universitetssykehus
Bergen, Norway, 5021
2
Oslo universitetssykehus, Radiumhospitalet
Oslo, Norway, 0310
3
Oslo universitetssykehus, Ullevål
Oslo, Norway, 0407
4
St Olavs Hospital
Trondheim, Norway, 7006