MedTrace Logo

Cetuximab in Combination With S-1 and Cisplatin in Gastric Cancer

NCT01388790 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2013-11-20

Study results available
· View outcomes & findings →

Summary

This open-label, single-arm, multicenter, Phase 2 trial will treat at least 40 participants with advanced gastric adenocarcinoma including adenocarcinoma of the gastroesophageal junction (GEJ) who have not previously received systemic chemotherapy for this setting.

All eligible participants will receive the combination of cetuximab plus S-1 (a combination of tegafur, gimeracil, and oteracil) and cisplatin.

Conditions

Interventions

DRUG

Cetuximab

Single first dose of cetuximab 400 milligram per square meter (mg/m\^2) will be administered intravenously followed by once weekly subsequent intravenous infusion of cetuximab 250 mg/m\^2 in each 5-week treatment cycle until disease progression, unacceptable toxicity, or withdrawal of consent.

DRUG

Cisplatin

Cisplatin 60 mg/m\^2 will administered as intravenous infusion on Day 8 of each 5-week cycle maximum up to 8 cycles until disease progression, unacceptable toxicity, or withdrawal of consent

DRUG

S-1

S-1, a combination of tegafur, gimeracil, and oteracil will be administered intravenously at a dose of 40 to 60 mg/m\^2 orally twice daily for first three consecutive weeks of 5-week cycle until disease progression, unacceptable toxicity, or withdrawal of consent.

Sponsors & Collaborators

  • Merck KGaA, Darmstadt, Germany

    lead INDUSTRY

Principal Investigators

  • Masataka Ota, MD · Merck Serono Co., Ltd., Japan

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2012-08-31
Completion
2013-05-31

Countries

  • Germany

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 NCT01388790 on ClinicalTrials.gov