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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-08-31

Study Completion Date

2008-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Esophageal Cancer Gastric Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Epirubicin, Cisplatin, Capecitabine (ECX)+Matuzumab

Group Type EXPERIMENTAL

Matuzumab

Intervention Type DRUG

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(mg) intravenously (IV) every week, until disease progression (PD), unacceptable toxicity, death, or consent is withdrawn.

Epirubicin

Intervention Type DRUG

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

Intervention Type DRUG

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

Capecitabine

Intervention Type DRUG

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

ECX Only

Group Type ACTIVE_COMPARATOR

Epirubicin

Intervention Type DRUG

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

Intervention Type DRUG

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

Capecitabine

Intervention Type DRUG

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

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No