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

NCT01388790 | Completed Phase 2 Results DMC

• 1 other identifier: EMR 062202-058
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Best Overall Response (BOR) Rate - Independent Review Committee (IRC) Assessments

  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).

  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)

Secondary Outcomes (1)

• 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)

Study Arms (1)

Cetuximab plus cisplatin plus S-1

EXPERIMENTAL

Drug: Cetuximab; Drug: Cisplatin; Drug: S-1

Interventions

Cetuximab 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.

Cetuximab plus cisplatin plus S-1

Cisplatin 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

Cetuximab plus cisplatin plus S-1

S-1 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.

Cetuximab plus cisplatin plus S-1

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck KGaA, Darmstadt, Germany: lead

Study Sites (1)

Please contact the Merck KGaA Communication Center located in

Darmstadt, Germany

Location

Related Publications (1)

• 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.

  PMID: 33561262 DERIVED

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Cetuximab; Cisplatin; S 1 (combination)

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Results Point of Contact

• Title: Merck KGaA Communication Center
• Organization: Merck Serono, a division of Merck KGaA

service@merckgroup.com

+49-6151-72-5200

Study Officials

• Masataka Ota, MD

  Merck Serono Co., Ltd., Japan

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2011
• First Posted: July 7, 2011
• Study Start: June 1, 2011
• Primary Completion: August 1, 2012
• Study Completion: May 1, 2013
• Last Updated: November 20, 2013
• Results First Posted: November 20, 2013

Record last verified: 2013-09

Locations

DE (1)