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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00113581
Recruitment Status : Completed
First Posted : June 10, 2005
Last Update Posted : February 19, 2014
Information provided by (Responsible Party):
Merck KGaA, Darmstadt, Germany

Brief Summary:

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).

Condition or disease Intervention/treatment Phase
Esophageal Cancer Gastric Cancer Drug: EMD 72000 (matuzumab) + ECX Phase 1

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Study Type : Interventional  (Clinical Trial)
Enrollment : 26 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : October 2002
Actual Primary Completion Date : May 2006
Actual Study Completion Date : January 2007

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Safety and tolerability

Secondary Outcome Measures :
  1. Pharmacodynamic parameters
  2. Pharmacokinetic parameters
  3. Response rate

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00113581

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United Kingdom
The Royal Marsden Hospital
London, United Kingdom
Sponsors and Collaborators
Merck KGaA, Darmstadt, Germany
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Principal Investigator: David Cunningham, Professor The Royal Marsden Hospital, Sutton, UK
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Responsible Party: Merck KGaA, Darmstadt, Germany Identifier: NCT00113581    
Other Study ID Numbers: EMD 72000-024
First Posted: June 10, 2005    Key Record Dates
Last Update Posted: February 19, 2014
Last Verified: February 2014
Keywords provided by Merck KGaA, Darmstadt, Germany:
EMD 72000
Esophageal adenocarcinoma
Gastric adenocarcinoma