MATRIX EG (Matuzumab Treatment With ECX in Esophago-Gastric Cancer) - Full Text View

Sponsored by:	EMD Serono
Information provided by:	EMD Serono
ClinicalTrials.gov Identifier:	NCT00215644

Purpose

The purpose of this study is to compare the effectiveness and safety of experimental treatment matuzumab and ECX chemotherapy, with ECX chemotherapy.

Subjects invited to take part have metastatic cancer of the esophagus (gullet) or stomach.

Condition	Intervention	Phase
Esophageal Cancer Gastric Cancer	Drug: ECX Drug: Matuzumab + ECX	Phase II

MedlinePlus related topics: Cancer Esophageal Cancer Esophagus Disorders Stomach Cancer

Drug Information available for: Matuzumab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Randomized Phase II Open-Label Controlled Study of EMD 72000 (Matuzumab), in Combination With the Chemotherapy Regimen ECX or the Chemotherapy Regimen ECX Alone as First-Line Treatment in Subjects With Metastatic Esophago-Gastric Adenocarcinoma

Further study details as provided by EMD Serono:

Primary Outcome Measures:

Response rate [ Time Frame: various timepoints measured ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Response duration [ Time Frame: various timepoints measured ] [ Designated as safety issue: No ]
median time to tumor progression [ Time Frame: various timepoints measured ] [ Designated as safety issue: No ]
median survival time [ Time Frame: various timepoints measured ] [ Designated as safety issue: No ]
safety and tolerability [ Time Frame: various timepoints measured ] [ Designated as safety issue: No ]
QoL [ Time Frame: various timepoints measured ] [ Designated as safety issue: No ]
protein biomarkers [ Time Frame: various timepoints measured ] [ Designated as safety issue: No ]
immunogenicity [ Time Frame: various timepoints measured ] [ Designated as safety issue: No ]
matuzumab peak and trough values [ Time Frame: various timepoints measured ] [ Designated as safety issue: No ]

Enrollment:	72
Study Start Date:	August 2005
Study Completion Date:	September 2008
Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator	Drug: ECX ECX given until progression of disease or unacceptable toxicity, for a maximum of 8 cycles- E= 50 mg per metre squared of Epirubicin given i.v. once every 3 weeks, C= 60 mg per metre squared of cisplatin given i.v. once every 3 weeks, X= 1250mg per metre squared divided into two oral doses of capecitabine given every day.
2: Experimental	Drug: Matuzumab + ECX 800mg matuzumab given i.v. (into the vein) once per week until progression or unacceptable toxicity, along with intervention in Arm 1 (ECX)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Histologically confirmed gastric adenocarcinoma or adenocarcinoma of the lower third of the esophagus
metastatic disease
immunohistological evidence of EGFR expression from archived tissues
ECOG PS 0-1
at least 1 measurable lesion (modified WHO criteria)

Exclusion Criteria:

previous chemotherapy, unless neo-adjuvant or adjuvant therapy completed > 12 months prior to study treatment
radiotherapy or major surgery within 4 weeks prior to treatment
brain metastases
peripheral neuropathy or ototoxicity >/= Grade 2 (NCICTC V3)
abnormal ECG

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00215644

Locations

Germany
Research Site
Essen, Germany
Research Site
Recklinghausen, Germany
Research Site
Hamburg, Germany
Research Site
Oldenburg, Germany
Spain
Research Site
Barcelona, Spain
Research Site
Valencia, Spain
Research Site
A Coruna, Spain
Research Site
Cadiz, Spain
Switzerland
Research Site
St. Gallen, Switzerland
Research Site
Lausanne, Switzerland
Research Site
Geneva, Switzerland
Research Site
Bern, Switzerland
United Kingdom
Research Site
Bournemouth, United Kingdom
Research Site
London, United Kingdom
Research Site
Leicester, United Kingdom
Research Site
Newcastle, United Kingdom
Research Site
Portsmouth, United Kingdom
Research Site
Cambridge, United Kingdom
Research Site
Northwood, United Kingdom
Research Site
Chelmsford, United Kingdom
Research Site
Guildford, United Kingdom
United Kingdom, Middlesex
Research Site
Northwood, Middlesex, United Kingdom

Sponsors and Collaborators

EMD Serono

Investigators

Principal Investigator:

Professor David Cunningham, MD, FRCP

The Royal Marsden Hospital, UK

More Information

No publications provided

Responsible Party:	Merck KGaA ( Hannah Pearce )
Study ID Numbers:	EMD 72000-032
Study First Received:	September 15, 2005
Last Updated:	March 21, 2009
ClinicalTrials.gov Identifier:	NCT00215644 History of Changes
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by EMD Serono:

Esophagus
Gastric
Adenocarcinoma
EGFR
matuzumab
EMD 72000

randomized
Epirubicin
cisplatin
capecitabine
Metastatic Esophago-Gastric cancer

Study placed in the following topic categories:

Capecitabine
Digestive System Neoplasms
Gastrointestinal Diseases
Esophageal Neoplasms
Esophageal Cancer
Epirubicin
Digestive System Diseases
Stomach Diseases

Cisplatin
Esophageal Disorder
Stomach Neoplasms
Head and Neck Neoplasms
Gastrointestinal Neoplasms
Esophageal Diseases
Stomach Cancer
Adenocarcinoma

Additional relevant MeSH terms:

Neoplasms
Stomach Diseases
Digestive System Diseases
Neoplasms by Site
Digestive System Neoplasms
Gastrointestinal Diseases

Head and Neck Neoplasms
Stomach Neoplasms
Esophageal Neoplasms
Gastrointestinal Neoplasms
Esophageal Diseases

ClinicalTrials.gov processed this record on May 07, 2009