Matuzumab Treatment With Epirubicin, Cisplatin and Capecitabine (ECX) in Esophago-Gastric Cancer

Gastric Cancer Clinical Trial

— MATRIX EG  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00215644
• Other study ID #: EMD 72000-032
• Secondary ID: 2005-000146-36
• Status: Completed
• Phase: Phase 2
• Start date: August 31, 2005
• Est. completion date: August 31, 2008

Study information

• Verified date: March 2018
• Source: Merck KGaA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: August 31, 2008
• Est. primary completion date: July 31, 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms
• Gastric Cancer
• Stomach Neoplasms

Intervention

Drug:
• Matuzumab
Participants will receive matuzumab 800 milligrams (mg) intravenously (IV) every week, until disease progression (PD), unacceptable toxicity, death, or consent is withdrawn.
• Epirubicin
Participants will receive epirubicin 50 milligrams per square meter (mg/m^2) on Day 1 of 21-day cycle up to a maximum of 8 cycles.
• Cisplatin
Participants will receive cisplatin 60 mg/m^2 on Day 1 of 21-day cycle up to a maximum of 8 cycles.
• Capecitabine
Participants will receive capecitabine 1250 mg/m^2 daily in a 21-day cycles up to a maximum of 8 cycles.

Locations

Country	Name	City	State
Germany	Research Site	Essen
Germany	Research Site	Hamburg
Germany	Research Site	Oldenburg
Germany	Research Site	Recklinghausen
Spain	Research Site	A Coruna
Spain	Research Site	Barcelona
Spain	Research Site	Cadiz
Spain	Research Site	Valencia
Switzerland	Research Site	Bern
Switzerland	Research Site	Geneva
Switzerland	Research Site	Lausanne
Switzerland	Research Site	St. Gallen
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	Northwood	Middlesex
United Kingdom	Research Site	Portsmouth

Sponsors (1)

Lead Sponsor	Collaborator
Merck KGaA

Countries where clinical trial is conducted

Germany,  Spain,  Switzerland,  United Kingdom, 

References & Publications (1)

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 al — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Objective Response Assessed by Independent Review Committee	Objective response was defined as having a complete response (CR) or a partial response (PR). Response assessment was performed using modified World Health Organization (WHO) criteria. CR: disappearance of all index and non-index lesions, without appearance of any new lesion. PR: greater than (>) 50 percent (%) decrease from baseline in sum of product of diameters of index lesions, without appearance of any new lesion.	Baseline up to PD or death due to any cause (up to approximately 3 years)
Secondary	Duration of Objective Response Assessed by Independent Review Committee	Objective response was defined as having a CR or a PR. Response assessment was performed using modified WHO criteria. CR: disappearance of all index and non-index lesions, without appearance of any new lesion. PR: >50% decrease from baseline in sum of product of diameters of index lesions, without appearance of any new lesion. Duration of objective response was defined as time from first appearance of CR or PR to time of PD (PD: >25% increase in one or more lesions, or appearance new lesions) or death. Duration of objective response was to be assessed using Kaplan-Meier analysis.	From first documented objective response to PD or death due to any cause (up to approximately 3 years)
Secondary	Progression-Free Survival	PFS was defined as the time from randomization to the first documentation of PD or to death due to any cause, whichever occurred first. PD: >25% increase in one or more lesions, or appearance new lesions. PFS was estimated using Kaplan-Meier analysis.	Baseline up to PD or death due to any cause (up to approximately 3 years)
Secondary	Overall Survival (OS)	OS was defined as the duration from randomization to death (due to any cause). OS was estimated using Kaplan-Meier analysis.	Baseline until death due to any cause (up to approximately 3 years)
Secondary	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	EORTC QLQ-C30 included GHS/QoL, functional scales (physical, role, cognitive, emotional, social), symptom scales (fatigue, pain, nausea/vomiting), and single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, financial difficulties). Most questions from EORTC QLQ-C30 were a 4-point scale (1/Not at All to 4/Very Much), except Items 29-30, which comprise GHS scale and were a 7-point scale (1/Very Poor to 7/Excellent). For this instrument, GHS/QOL was linearly transformed and ranged 0-100, where lower scores indicate poorer functioning (e.g., worsening) and higher scores indicate better functioning (e.g., improvement). EORTC QLQ-C30 GHS/QoL score at baseline and best overall change from baseline (throughout study) are reported.	Baseline (Day 1), Post Baseline (Up to 3 Years)
Secondary	Protein Biomarkers Levels		Baseline up to approximately 3 years
Secondary	Percentage of Participants With Anti-Matuzumab Antibodies		Baseline up to approximately 3 years
Secondary	Matuzumab Serum Concentration		Baseline up to approximately 3 years