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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

September 15, 2005
February 17, 2014
August 2005
July 2008   (final data collection date for primary outcome measure)
Response rate [ Time Frame: various timepoints measured ] [ Designated as safety issue: No ]
Response rate
Complete list of historical versions of study NCT00215644 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
72
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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany,   Spain,   Switzerland,   United Kingdom
 
NCT00215644
EMD 72000-032
No
Claire Beadman-Lakey, Merck KGaA
Merck KGaA
Not Provided
Principal Investigator: Professor David Cunningham, MD, FRCP The Royal Marsden Hospital, UK
Merck KGaA
February 2014

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