MATRIX EG (Matuzumab Treatment With ECX in Esophago-Gastric 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: NCT00215644
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : November 7, 2016
Information provided by (Responsible Party):
Merck KGaA

September 15, 2005
September 22, 2005
November 7, 2016
August 2005
July 2008   (Final data collection date for primary outcome measure)
Response rate [ Time Frame: various timepoints measured ]
Response rate
Complete list of historical versions of study NCT00215644 on Archive Site
  • Response duration [ Time Frame: various timepoints measured ]
  • median time to tumor progression [ Time Frame: various timepoints measured ]
  • median survival time [ Time Frame: various timepoints measured ]
  • safety and tolerability [ Time Frame: various timepoints measured ]
  • QoL [ Time Frame: various timepoints measured ]
  • protein biomarkers [ Time Frame: various timepoints measured ]
  • immunogenicity [ Time Frame: various timepoints measured ]
  • matuzumab peak and trough values [ Time Frame: various timepoints measured ]
  • Response duration
  • median time to tumor progression
  • median survival time
  • safety and tolerability
  • QoL
  • protein biomarkers
  • immunogenicity
  • matuzumab peak and trough values
Not Provided
Not Provided
MATRIX EG (Matuzumab Treatment With ECX in Esophago-Gastric Cancer)
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
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.
Not Provided
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Esophageal Cancer
  • Gastric Cancer
  • 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)
  • Active Comparator: 1
    Intervention: Drug: ECX
  • Experimental: 2
    Intervention: Drug: Matuzumab + ECX
Rao S, Starling N, Cunningham D, Sumpter K, Gilligan D, Ruhstaller T, Valladares-Ayerbes M, Wilke H, Archer C, Kurek R, Beadman C, Oates J. Matuzumab plus epirubicin, cisplatin and capecitabine (ECX) compared with epirubicin, cisplatin and capecitabine alone as first-line treatment in patients with advanced oesophago-gastric cancer: a randomised, multicentre open-label phase II study. Ann Oncol. 2010 Nov;21(11):2213-9. doi: 10.1093/annonc/mdq247. Epub 2010 May 23.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
August 2008
July 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Germany,   Spain,   Switzerland,   United Kingdom
EMD 72000-032
Not Provided
Not Provided
Merck KGaA
Merck KGaA
Not Provided
Principal Investigator: Professor David Cunningham, MD, FRCP The Royal Marsden Hospital, UK
Merck KGaA
November 2016

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