TaxXel: Taxotere and Xeloda in Esophageal Cancer

Phase 1

• Conditions: Cancer of the Esophagus; Gastric Cardia Carcinoma
• Interventions: Drug: Docetaxel; Drug: Capecitabine

• Registration Number: NCT00821912
• Lead Sponsor: Karolinska University Hospital

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2006-03
• Study First Submitted: 2009-01-13
• Study First Submitted QC: 2009-01-13
• Study First Posted: 2009-01-14
• Status Verified: 2012-02
• Last Update Submitted: 2012-02-27
• Last Update Posted: 2012-02-28
• Primary Completion: 2012-09
• Study Completion: 2013-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 93

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Taxotere Xeloda	Capecitabine	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.
Taxotere Xeloda	Docetaxel	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Quality of life	Every three weeks
CT scan	Every 9 weeks
Toxicity assessment	Every three weeks

Trial Locations

Locations (10)

Haukeland universitetssykehus; 🇳🇴 Bergen, Norway

Malmö General University Hospital; 🇸🇪 Malmö, Sweden

Västerås Central Hospital; 🇸🇪 Västerås, Sweden

Karolinska University Hospital, Dept of Oncology; 🇸🇪 Stockholm, Sweden

Uppsala Akademic Hospital; 🇸🇪 Uppsala, Sweden

Oslo universitetssykehus, Radiumhospitalet; 🇳🇴 Oslo, Norway

St Olavs Hospital; 🇳🇴 Trondheim, Norway

Oslo universitetssykehus, Ullevål; 🇳🇴 Oslo, Norway

Linköping University Hospital; 🇸🇪 Linköping, Sweden

Sundsvall County Hospital; 🇸🇪 Sundsvall, Sweden