Safety Study of EMD 72000 in Combination With ECX (Epirubicin, Cisplatin and Capecitabine) in Oesophagogastric Cancer

NCT ID: NCT00113581

Last Updated: 2014-02-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-10-31

Study Completion Date

2007-01-31

Brief Summary

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The main purpose of this study is to test the safety and tolerability and effectiveness of a new treatment, EMD 72000 (matuzumab), for advanced oesophagogastric cancer in combination with the chemotherapy regimen ECX (epirubicin, cisplatin and capecitabine).

In addition the study will look at pharmacokinetic (how the the body takes up the drug) and pharmacodynamic parameters (what the drug does in the body).

Detailed Description

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Conditions

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Esophageal Cancer Gastric Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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EMD 72000 (matuzumab) + ECX

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Advanced, recurrent or metastatic gastric adenocarcinoma or adenocarcinoma of the lower third of the esophagus
* EGFR positive tumor
* KPS greater than 60
* Normal cardiac function
* Adequate liver and bone marrow function
* GFR greater than 60 ml/minute

Exclusion Criteria

* Previous chemotherapy
* Uncontrolled angina pectoris, heart failure, clinically significant uncontrolled cardiac arrythmias
* Clinically significant ECG or cardiac history
* Radiotherapy or surgery within last 4 weeks
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck KGaA, Darmstadt, Germany

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David Cunningham, Professor

Role: PRINCIPAL_INVESTIGATOR

The Royal Marsden Hospital, Sutton, UK

Locations

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The Royal Marsden Hospital

London, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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EMD 72000-024

Identifier Type: -

Identifier Source: org_study_id

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