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

Phase 2

Completed

Conditions: Gastric Cancer

Interventions: Drug: Cetuximab
Drug: Cisplatin
Drug: S-1

Registration Number: NCT01388790

Lead Sponsor: Merck KGaA, Darmstadt, Germany

Brief 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 40

Inclusion Criteria

Written informed consent and agreement with medically accepted contraception (in participants with conception potential) are obtained
Japanese participants aged greater than or equal to 20 years
Histologically confirmed adenocarcinoma of the stomach or GEJ (adenocarcinomas of the esophagogastric junction types I to III according to Siewert's classification) in Stage M0 (unresectable advanced) or Stage M1 (unresectable metastatic) of the disease
Archived tumor material sample for at least subsequent standardized epidermal growth factor receptor (EGFR) expression and Kirsten-rat sarcoma (KRAS) mutation assessments
At least one radiographically documented measurable lesion in a previously non-irradiated area according to the RECIST v 1.0
Eastern Cooperative Oncology Group - performance status (ECOG-PS) 0 to 1
Estimated life expectancy greater than 12 weeks
Renal, liver and hematopoietic function as defined in the protocol.
Sodium and potassium within normal limits or as defined in the protocol
Other protocol defined inclusion criteria could apply

Exclusion Criteria

Prior therapies: prior treatment with an antibody or molecule targeting EGFR- and/or vascular endothelial growth factor (VEGF) receptor-related signaling pathways; chemotherapies; or radiotherapies, major surgeries, and any investigational drugs in the 30 days before the start of trial treatment
Concurrent chronic systemic immune or hormone therapy not indicated in this trial protocol any contraindication to treatment with cetuximab and cisplatin, or any treatments with prohibited concomitant drugs
Brain metastasis and/or leptomeningeal disease
Clinically relevant coronary artery disease (New York Heart Association [NYHA] functional angina classification III/IV), congestive heart failure (NYHA III/IV), clinically relevant cardiomyopathy, history of myocardial infarction in the last 12 months, or high risk of uncontrolled arrhythmia
Chronic diarrhea or short bowel syndrome
Known Human Immunodeficiency Virus (HIV) infection, active or chronic carrier of hepatitis B virus (HBV) (HBV antigen positive or HBV deoxyribonucleic acid (DNA) positive) or hepatitis C virus (HCV) (HCV antibody positive)
Pregnancy or lactation period
Concurrent treatment with a non-permitted drug (any other chemotherapy, systemic anticancer therapy or immunotherapy)
Previous malignancy other than gastric cancer in the last 5 years Medical or psychological conditions that would not permit the participant to complete the trial or sign the Informed Consent Form (ICF)
Legal incapacity or limited legal capacity
Other protocol defined exclusion criteria could apply

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cetuximab plus cisplatin plus S-1	Cetuximab	-
Cetuximab plus cisplatin plus S-1	Cisplatin	-
Cetuximab plus cisplatin plus S-1	S-1	-

Primary Outcome Measures

Name	Time	Method
Best Overall Response (BOR) Rate - Independent Review Committee (IRC) Assessments	Evaluations were performed every 6 weeks until disease progression, reported between day of first participant treated, that is July 2011, until cut-off date, (14 August 2012)	The best overall response rate is defined as the percentage of participants having achieved confirmed complete response plus partial response as the best overall response according to radiological assessments (based on Response Evaluation Criteria in Solid Tumors version 1.0 \[RECIST v 1.0\] criteria).

Secondary Outcome Measures

Name	Time	Method
Median Progression-free Survival (PFS) Time - Independent Review Committee (IRC) Assessments	Time from start of treatment to disease progression, death or last tumor assessment, reported between day of first participant treated, that is July 2011, until cut-off date, (14 August 2012)	The PFS time is defined as the duration from start of treatment until radiological progression (based on RECIST v 1.0 criteria) or death due to any cause within 60 days of the last tumor assessment or start of treatment. Participants without event are censored on the date of last tumor assessment.