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: November 24, 2010

Last verified: November 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

September 15, 2005

Last Updated Date

November 24, 2010

Start Date ^ICMJE

August 2005

Primary Completion Date

July 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Response rate

Change History

Complete list of historical versions of study NCT00215644 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Response duration
median time to tumor progression
median survival time
safety and tolerability
QoL
protein biomarkers
immunogenicity
matuzumab peak and trough values

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

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

Condition ^ICMJE

Esophageal Cancer
Gastric Cancer

Intervention ^ICMJE

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.
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)

Study Arm (s)

Active Comparator: 1
Intervention: Drug: ECX
Experimental: 2
Intervention: Drug: Matuzumab + ECX

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

August 2008

Primary Completion Date

July 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Germany, Spain, Switzerland, United Kingdom

Administrative Information

NCT Number ^ICMJE

NCT00215644

Other Study ID Numbers ^ICMJE

EMD 72000-032

Has Data Monitoring Committee

Responsible Party

Claire Beadman-Lakey, Merck KGaA

Study Sponsor ^ICMJE

Merck KGaA

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Professor David Cunningham, MD, FRCP

The Royal Marsden Hospital, UK

Information Provided By

Merck KGaA

Verification Date

November 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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