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TaxXel: Taxotere and Xeloda in Esophageal Cancer

Information source: Karolinska University Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Cancer of the Esophagus; Gastric Cardia Carcinoma

Intervention: Docetaxel (Drug); Capecitabine (Drug)

Phase: Phase 1/Phase 2

Status: Active, not recruiting

Sponsored by: Karolinska University Hospital

Official(s) and/or principal investigator(s):
Signe Friesland, MD, PhD, Principal Investigator, Affiliation: Karolinska University Hospital

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.

Clinical Details

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

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Response rate

Secondary outcome:

CT scan

Toxicity assessment

Quality of life

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

Haukeland universitetssykehus, Bergen 5021, Norway

Oslo universitetssykehus, Radiumhospitalet, Oslo 0310, Norway

Oslo universitetssykehus, Ullevål, Oslo 0407, Norway

St Olavs Hospital, Trondheim 7006, Norway

Linköping University Hospital, Linköping 581 85, Sweden

Malmö General University Hospital, Malmö 20502, Sweden

Karolinska University Hospital, Dept of Oncology, Stockholm 171 76, Sweden

Sundsvall County Hospital, Sundsvall 851 86, Sweden

Uppsala Akademic Hospital, Uppsala 751 85, Sweden

Västerås Central Hospital, Västerås 721 89, Sweden

Additional Information

Swedish website of the study

Starting date: March 2006
Last updated: February 27, 2012

Page last updated: August 23, 2015

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