TaxXel: Taxotere and Xeloda in Esophageal Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by Karolinska University Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Signe Friesland, Karolinska University Hospital
ClinicalTrials.gov Identifier:
NCT00821912
First received: January 13, 2009
Last updated: February 27, 2012
Last verified: February 2012
  Purpose

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 Intervention Phase
Cancer of the Esophagus
Gastric Cardia Carcinoma
Drug: Docetaxel
Drug: Capecitabine
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Karolinska University Hospital:

Primary Outcome Measures:
  • Response rate [ Designated as safety issue: No ]

    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:
  • CT scan [ Time Frame: Every 9 weeks ] [ Designated as safety issue: No ]
  • Toxicity assessment [ Time Frame: Every three weeks ] [ Designated as safety issue: Yes ]
  • Quality of life [ Time Frame: Every three weeks ] [ Designated as safety issue: No ]

Enrollment: 93
Study Start Date: March 2006
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00821912

Locations
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
Principal Investigator: Signe Friesland, MD, PhD Karolinska University Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: Signe Friesland, MD, PhD, Karolinska University Hospital
ClinicalTrials.gov Identifier: NCT00821912     History of Changes
Other Study ID Numbers: TaxXel
Study First Received: January 13, 2009
Last Updated: February 27, 2012
Health Authority: Sweden: Medical Products Agency

Additional relevant MeSH terms:
Carcinoma
Esophageal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Docetaxel
Capecitabine
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites

ClinicalTrials.gov processed this record on August 01, 2014