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

Gastric Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00113581
• Other study ID #: EMD 72000-024
• Status: Completed
• Phase: Phase 1
• First received: June 9, 2005
• Last updated: February 17, 2014
• Start date: October 2002
• Est. completion date: January 2007

Study information

• Verified date: February 2014
• Source: Merck KGaA
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: January 2007
• Est. primary completion date: May 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms
• Gastric Cancer

Intervention

Drug:
• EMD 72000 (matuzumab) + ECX

Locations

Country	Name	City	State
United Kingdom	The Royal Marsden Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
Merck KGaA

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability
Secondary	Pharmacodynamic parameters
Secondary	Pharmacokinetic parameters
Secondary	Response rate