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

NCT ID: NCT01388790

Last Updated: 2013-11-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-06-30
• Study Completion Date: 2013-05-31

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.

Conditions

Gastric Cancer

Keywords

Gastric Cancer; Cetuximab; EMD271786; TS-1; Cisplatin

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cetuximab plus cisplatin plus S-1

Group Type: EXPERIMENTAL

Cetuximab

Intervention Type: DRUG

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.

Cisplatin

Intervention Type: DRUG

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

S-1

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

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

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck KGaA, Darmstadt, Germany

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Masataka Ota, MD

Role: STUDY_DIRECTOR

Merck Serono Co., Ltd., Japan

Locations

Please contact the Merck KGaA Communication Center located in

Darmstadt, , Germany

Countries

Japan; Germany

References

Yamaguchi K, Fuse N, Komatsu Y, Fujii H, Hironaka S, Omuro Y, Muro K, Yasui H, Ueda S, Nishina T, Watanabe M, Ohtsu A. Phase II study of cetuximab plus S-1/cisplatin therapy in Japanese patients with advanced gastric cancer. Jpn J Clin Oncol. 2021 May 28;51(6):879-885. doi: 10.1093/jjco/hyaa276.

Reference Type: DERIVED

PMID: 33561262 (View on PubMed)

Other Identifiers

EMR 062202-058

Identifier Type: -

Identifier Source: org_study_id