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

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Trial phase: 
Phase I
Recruitment status: 
Completed

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).

Background information
Trial ID: 
NCT00113581
Other unique IDs: 
EMD 72000-024
Official title: 

A Phase I Study to Determine the Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of Three Doses of Humanised EGFR Antibody EMD 72000 in Combination With ECX in Patients With Advanced Oesophagogastric Adenocarcinoma

Detailed description: 

 

Number to be enrolled: 
26 patients
Clinical information
Age groups: 
Adult
Senior
Gender: 
Both
Eligibility criteria: 

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

Study design: 
Treatment
Single Group Assignment
Open Label
Safety Study
Non-Randomized
Uncontrolled
Interventions: 
EMD 72000 (matuzumab) + ECX
Conditions treated: 
Esophageal Cancer
Gastric Cancer
Outcome measurements: 

Response rate

Pharmacodynamic parameters

Pharmacokinetic parameters

Funding
Funding types: 
INDUSTRY
Sponsor: 
EMD Serono
Dates
Date the data was first received: 
Thu, 2005-06-09
Trial start date: 
Mon, 2002-07-01
Trial completion date: 
Wed, 2006-02-01
Trial last updated: 
Wed, 2009-05-20