search
Back to results

TaxXel: Taxotere and Xeloda in Esophageal Cancer (TaxXel)

Primary Purpose

Cancer of the Esophagus, Gastric Cardia Carcinoma

Status
Unknown status
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Docetaxel
Capecitabine
Sponsored by
Karolinska University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cancer of the Esophagus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Haukeland universitetssykehus
  • Oslo universitetssykehus, Radiumhospitalet
  • Oslo universitetssykehus, Ullevål
  • St Olavs Hospital
  • Linköping University Hospital
  • Malmö General University Hospital
  • Karolinska University Hospital, Dept of Oncology
  • Sundsvall County Hospital
  • Uppsala Akademic Hospital
  • Västerås Central Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Taxotere Xeloda

Arm Description

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.

Outcomes

Primary Outcome Measures

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

CT scan
Toxicity assessment
Quality of life

Full Information

First Posted
January 13, 2009
Last Updated
February 27, 2012
Sponsor
Karolinska University Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT00821912
Brief Title
TaxXel: Taxotere and Xeloda in Esophageal Cancer
Acronym
TaxXel
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 Type
Interventional

2. Study Status

Record Verification Date
February 2012
Overall Recruitment Status
Unknown status
Study Start Date
March 2006 (undefined)
Primary Completion Date
September 2012 (Anticipated)
Study Completion Date
September 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer of the Esophagus, Gastric Cardia Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
93 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Taxotere Xeloda
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Other Intervention Name(s)
Taxotere
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Capecitabine
Other Intervention Name(s)
Xeloda
Intervention Description
1650 mg/m2 /day orally b.i.d., day 1-14 every 3 weeks.
Primary Outcome Measure Information:
Title
Response rate
Description
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 Measure Information:
Title
CT scan
Time Frame
Every 9 weeks
Title
Toxicity assessment
Time Frame
Every three weeks
Title
Quality of life
Time Frame
Every three weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Signe Friesland, MD, PhD
Organizational Affiliation
Karolinska University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Haukeland universitetssykehus
City
Bergen
ZIP/Postal Code
5021
Country
Norway
Facility Name
Oslo universitetssykehus, Radiumhospitalet
City
Oslo
ZIP/Postal Code
0310
Country
Norway
Facility Name
Oslo universitetssykehus, Ullevål
City
Oslo
ZIP/Postal Code
0407
Country
Norway
Facility Name
St Olavs Hospital
City
Trondheim
ZIP/Postal Code
7006
Country
Norway
Facility Name
Linköping University Hospital
City
Linköping
ZIP/Postal Code
581 85
Country
Sweden
Facility Name
Malmö General University Hospital
City
Malmö
ZIP/Postal Code
20502
Country
Sweden
Facility Name
Karolinska University Hospital, Dept of Oncology
City
Stockholm
ZIP/Postal Code
171 76
Country
Sweden
Facility Name
Sundsvall County Hospital
City
Sundsvall
ZIP/Postal Code
851 86
Country
Sweden
Facility Name
Uppsala Akademic Hospital
City
Uppsala
ZIP/Postal Code
751 85
Country
Sweden
Facility Name
Västerås Central Hospital
City
Västerås
ZIP/Postal Code
721 89
Country
Sweden

12. IPD Sharing Statement

Learn more about this trial

TaxXel: Taxotere and Xeloda in Esophageal Cancer

We'll reach out to this number within 24 hrs