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

January 13, 2009
February 27, 2012
March 2006
September 2012   (final data collection date for primary outcome measure)
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.

Response rate [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00821912 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
TaxXel: Taxotere and Xeloda in Esophageal Cancer
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.

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Cancer of the Esophagus
  • Gastric Cardia Carcinoma
  • 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
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.

Interventions:
  • Drug: Docetaxel
  • Drug: Capecitabine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
93
September 2013
September 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Norway,   Sweden
 
NCT00821912
TaxXel
No
Signe Friesland, Karolinska University Hospital
Karolinska University Hospital
Not Provided
Principal Investigator: Signe Friesland, MD, PhD Karolinska University Hospital
Karolinska University Hospital
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP