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TaxXel: Taxotere and Xeloda in Esophageal Cancer (TaxXel)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00821912
Recruitment Status : Unknown
Verified February 2012 by Signe Friesland, Karolinska University Hospital.
Recruitment status was:  Active, not recruiting
First Posted : January 14, 2009
Last Update Posted : February 28, 2012
Sponsor:
Information provided by (Responsible Party):
Signe Friesland, Karolinska University Hospital

Study Description
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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 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.


Condition or disease Intervention/treatment Phase
Cancer of the Esophagus Gastric Cardia Carcinoma Drug: Docetaxel Drug: Capecitabine Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 93 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : March 2006
Estimated Primary Completion Date : September 2012
Estimated Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Docetaxel

Arms and Interventions
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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 Name: Taxotere

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


Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. CT scan [ Time Frame: Every 9 weeks ]
  2. Toxicity assessment [ Time Frame: Every three weeks ]
  3. Quality of life [ Time Frame: Every three weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00821912


Locations
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Norway
Haukeland universitetssykehus
Bergen, Norway, 5021
Oslo universitetssykehus, Radiumhospitalet
Oslo, Norway, 0310
Oslo universitetssykehus, Ullevål
Oslo, Norway, 0407
St Olavs Hospital
Trondheim, Norway, 7006
Sweden
Linköping University Hospital
Linköping, Sweden, 581 85
Malmö General University Hospital
Malmö, Sweden, 20502
Karolinska University Hospital, Dept of Oncology
Stockholm, Sweden, 171 76
Sundsvall County Hospital
Sundsvall, Sweden, 851 86
Uppsala Akademic Hospital
Uppsala, Sweden, 751 85
Västerås Central Hospital
Västerås, Sweden, 721 89
Sponsors and Collaborators
Karolinska University Hospital
Investigators
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Principal Investigator: Signe Friesland, MD, PhD Karolinska University Hospital
More Information
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Responsible Party: Signe Friesland, MD, PhD, Karolinska University Hospital
ClinicalTrials.gov Identifier: NCT00821912    
Other Study ID Numbers: TaxXel
First Posted: January 14, 2009    Key Record Dates
Last Update Posted: February 28, 2012
Last Verified: February 2012
Additional relevant MeSH terms:
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Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
 Docetaxel
Capecitabine
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites