TaxXel: Taxotere and Xeloda in Esophageal Cancer (TaxXel)

February 27, 2012 updated by: Signe Friesland, Karolinska University Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

93

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Bergen, Norway, 5021
        • Haukeland Universitetssykehus
      • Oslo, Norway, 0310
        • Oslo universitetssykehus, Radiumhospitalet
      • Oslo, Norway, 0407
        • Oslo universitetssykehus, Ullevål
      • Trondheim, Norway, 7006
        • St Olavs Hospital
  • Sweden
      • Linköping, Sweden, 581 85
        • Linköping University Hospital
      • Malmö, Sweden, 20502
        • Malmö General University Hospital
      • Stockholm, Sweden, 171 76
        • Karolinska University Hospital, Dept of Oncology
      • Sundsvall, Sweden, 851 86
        • Sundsvall County Hospital
      • Uppsala, Sweden, 751 85
        • Uppsala Akademic Hospital
      • Västerås, Sweden, 721 89
        • Västerås Central Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Taxotere Xeloda

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
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
Other Names:
  • Taxotere
Drug: Capecitabine
1650 mg/m2 /day orally b.i.d., day 1-14 every 3 weeks.
Other Names:
  • Xeloda

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska University Hospital

Investigators

  • Principal Investigator: Signe Friesland, MD, PhD, Karolinska University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2006

Primary Completion (Anticipated)

September 1, 2012

Study Completion (Anticipated)

September 1, 2013

Study Registration Dates

First Submitted

January 13, 2009

First Submitted That Met QC Criteria

January 13, 2009

First Posted (Estimate)

January 14, 2009

Study Record Updates

Last Update Posted (Estimate)

February 28, 2012

Last Update Submitted That Met QC Criteria

February 27, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TaxXel

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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