Clinical trial NCT00215644: Matuzumab Treatment With Epirubicin, Cisplatin and Capecitabine (ECX) in Esophago-Gastric Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Esophageal Cancer
Gastric Cancer
Keywords: Esophagus
Gastric
Adenocarcinoma
EGFR
matuzumab
EMD 72000
randomized
Epirubicin
cisplatin
capecitabine
Metastatic Esophago-Gastric cancer
Lead sponsor: Merck KGaA, Darmstadt, Germany
Sponsor class: INDUSTRY
First posted: 2005-09-22
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the effectiveness and safety of experimental treatment matuzumab and ECX chemotherapy, with ECX chemotherapy. Participants invited to take part have metastatic cancer of the esophagus (gullet) or stomach.


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed gastric adenocarcinoma or adenocarcinoma of the lower third of the esophagus
* Metastatic disease
* Immunohistological evidence of Epidermal Growth Factor Receptor (EGFR) expression from archived tissues
* Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-1
* At least 1 measurable lesion (modified World Health Organization criteria)

Exclusion Criteria:

* Previous chemotherapy, unless neo-adjuvant or adjuvant therapy completed greater than (\>) 12 months prior to study treatment
* Radiotherapy or major surgery within 4 weeks prior to treatment
* Brain metastases
* Peripheral neuropathy or ototoxicity greater than or equal to (\>/=) Grade 2 (National Cancer Institute Common Terminology Criteria for Adverse Events Version 3 \[NCICTC V3\])
* Abnormal electrocardiogram (ECG)

Primary outcomes:
measure: Percentage of Participants With Objective Response Assessed by Independent Review Committee
timeFrame: Baseline up to PD or death due to any cause (up to approximately 3 years)
Secondary outcomes:
measure: Duration of Objective Response Assessed by Independent Review Committee
timeFrame: From first documented objective response to PD or death due to any cause (up to approximately 3 years)
measure: Progression-Free Survival
timeFrame: Baseline up to PD or death due to any cause (up to approximately 3 years)
measure: Overall Survival (OS)
timeFrame: Baseline until death due to any cause (up to approximately 3 years)
measure: Best Overall Change From Baseline in European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status (GHS)/Quality of Life (QoL) Score
timeFrame: Baseline (Day 1), Post Baseline (Up to 3 Years)
measure: Protein Biomarkers Levels
timeFrame: Baseline up to approximately 3 years
measure: Percentage of Participants With Anti-Matuzumab Antibodies
timeFrame: Baseline up to approximately 3 years
measure: Matuzumab Serum Concentration
timeFrame: Baseline up to approximately 3 years
Other outcomes:
Locations:
city: Essen
country: Germany
facility: Research Site
city: Hamburg
country: Germany
facility: Research Site
city: Oldenburg
country: Germany
facility: Research Site
city: Recklinghausen
country: Germany
facility: Research Site
city: A Coruna
country: Spain
facility: Research Site
city: Barcelona
country: Spain
facility: Research Site
city: Cadiz
country: Spain
facility: Research Site
city: Valencia
country: Spain
facility: Research Site
city: Bern
country: Switzerland
facility: Research Site
city: Geneva
country: Switzerland
facility: Research Site
city: Lausanne
country: Switzerland
facility: Research Site
city: St. Gallen
country: Switzerland
facility: Research Site
city: Northwood
country: United Kingdom
facility: Research Site
state: Middlesex
city: Bournemouth
country: United Kingdom
facility: Research Site
city: Cambridge
country: United Kingdom
facility: Research Site
city: Chelmsford
country: United Kingdom
facility: Research Site
city: Guildford
country: United Kingdom
facility: Research Site
city: Leicester
country: United Kingdom
facility: Research Site
city: London
country: United Kingdom
facility: Research Site
city: Newcastle
country: United Kingdom
facility: Research Site
city: Northwood
country: United Kingdom
facility: Research Site
city: Portsmouth
country: United Kingdom
facility: Research Site
Study officials:
affiliation: Merck KGaA, Darmstadt, Germany
name: Medical Responsible
role: STUDY_DIRECTOR
References:
citation: 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):2213-2219. doi: 10.1093/annonc/mdq247. Epub 2010 May 23.