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

This study has been completed.
Sponsor:
Information provided by:
Merck KGaA
ClinicalTrials.gov Identifier:
NCT00215644
First received: September 15, 2005
Last updated: February 17, 2014
Last verified: February 2014
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Merck KGaA:

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: August 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 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.
Experimental: 2 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
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, see Learn About Clinical Studies.

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

Locations
Germany
Research Site
Essen, Germany
Research Site
Hamburg, Germany
Research Site
Oldenburg, Germany
Research Site
Recklinghausen, Germany
Spain
Research Site
A Coruna, Spain
Research Site
Barcelona, Spain
Research Site
Cadiz, Spain
Research Site
Valencia, Spain
Switzerland
Research Site
Bern, Switzerland
Research Site
Geneva, Switzerland
Research Site
Lausanne, Switzerland
Research Site
St. Gallen, Switzerland
United Kingdom
Research Site
Northwood, Middlesex, United Kingdom
Research Site
Bournemouth, United Kingdom
Research Site
Cambridge, United Kingdom
Research Site
Chelmsford, United Kingdom
Research Site
Guildford, United Kingdom
Research Site
Leicester, United Kingdom
Research Site
London, United Kingdom
Research Site
Newcastle, United Kingdom
Research Site
Northwood, United Kingdom
Research Site
Portsmouth, United Kingdom
Sponsors and Collaborators
Merck KGaA
Investigators
Principal Investigator: Professor David Cunningham, MD, FRCP The Royal Marsden Hospital, UK
  More Information

No publications provided

Responsible Party: Claire Beadman-Lakey, Merck KGaA
ClinicalTrials.gov Identifier: NCT00215644     History of Changes
Other Study ID Numbers: EMD 72000-032
Study First Received: September 15, 2005
Last Updated: February 17, 2014
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Merck KGaA:
Esophagus
Gastric
Adenocarcinoma
EGFR
matuzumab
EMD 72000
randomized
Epirubicin
cisplatin
capecitabine
Metastatic Esophago-Gastric cancer

Additional relevant MeSH terms:
Adenocarcinoma
Esophageal Neoplasms
Stomach Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Stomach Diseases

ClinicalTrials.gov processed this record on July 29, 2014