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

NCT00215644 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2018-11-02

Study results available
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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.

Conditions

Interventions

DRUG

Matuzumab

Participants will receive matuzumab 800 milligrams (mg) intravenously (IV) every week, until disease progression (PD), unacceptable toxicity, death, or consent is withdrawn.

DRUG

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.

DRUG

Cisplatin

Participants will receive cisplatin 60 mg/m\^2 on Day 1 of 21-day cycle up to a maximum of 8 cycles.

DRUG

Capecitabine

Participants will receive capecitabine 1250 mg/m\^2 daily in a 21-day cycles up to a maximum of 8 cycles.

Sponsors & Collaborators

  • Merck KGaA, Darmstadt, Germany

    lead INDUSTRY

Principal Investigators

  • Medical Responsible · Merck KGaA, Darmstadt, Germany

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-08-31
Primary Completion
2008-07-31
Completion
2008-08-31

Countries

  • Germany
  • Spain
  • Switzerland
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00215644 on ClinicalTrials.gov