TaxXel: Taxotere and Xeloda in Esophageal Cancer

Cancer of the Esophagus Clinical Trial

— 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00821912
• Other study ID #: TaxXel
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• First received: January 13, 2009
• Last updated: February 27, 2012
• Start date: March 2006
• Est. completion date: September 2013

Study information

• Verified date: February 2012
• Source: Karolinska University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 93
• Est. completion date: September 2013
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cancer of the Esophagus
• Esophageal Neoplasms
• Gastric Cardia Carcinoma

Intervention

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
• Capecitabine
1650 mg/m2 /day orally b.i.d., day 1-14 every 3 weeks.

Locations

Country	Name	City	State
Norway	Haukeland universitetssykehus	Bergen
Norway	Oslo universitetssykehus, Radiumhospitalet	Oslo
Norway	Oslo universitetssykehus, Ullevål	Oslo
Norway	St Olavs Hospital	Trondheim
Sweden	Linköping University Hospital	Linköping
Sweden	Malmö General University Hospital	Malmö
Sweden	Karolinska University Hospital, Dept of Oncology	Stockholm
Sweden	Sundsvall County Hospital	Sundsvall
Sweden	Uppsala Akademic Hospital	Uppsala
Sweden	Västerås Central Hospital	Västerås

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska University Hospital

Countries where clinical trial is conducted

Norway,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		No
Secondary	CT scan		Every 9 weeks	No
Secondary	Toxicity assessment		Every three weeks	Yes
Secondary	Quality of life		Every three weeks	No

External Links

•   Swedish website of the study