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

Primary Purpose

Gastric Cancer

Status

Completed

Phase

Phase 2

Locations

Germany

Study Type

Interventional

Intervention

Cetuximab

Cisplatin

S-1

About this trial

This is an interventional treatment trial for Gastric Cancer focused on measuring Gastric Cancer, Cetuximab, EMD271786, TS-1, Cisplatin

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Please contact the Merck KGaA Communication Center located in

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cetuximab plus cisplatin plus S-1

Arm Description

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Median Progression-free Survival (PFS) Time - Independent Review Committee (IRC) Assessments

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.

Full Information

NCT ID

NCT01388790

First Posted

June 24, 2011

Last Updated

September 9, 2013

Sponsor

Merck KGaA, Darmstadt, Germany

1. Study Identification

Unique Protocol Identification Number

NCT01388790

Brief Title

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

Official Title

Open-label, Single-arm, Multicenter Phase II Trial Investigating Cetuximab in Combination With S-1 and Cisplatin as First-line Treatment for Patients With Advanced Gastric Adenocarcinoma Including Adenocarcinoma of the Gastroesophageal Junction

Study Type

Interventional

2. Study Status

Record Verification Date

September 2013

Overall Recruitment Status

Completed

Study Start Date

June 2011 (undefined)

Primary Completion Date

August 2012 (Actual)

Study Completion Date

May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Merck KGaA, Darmstadt, Germany

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gastric Cancer

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cetuximab plus cisplatin plus S-1

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Cetuximab

Intervention Description

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

Intervention Name(s)

Cisplatin

Intervention Description

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

Intervention Name(s)

S-1

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Description

Time Frame

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 Outcome Measure Information:

Title

Median Progression-free Survival (PFS) Time - Independent Review Committee (IRC) Assessments

Description

Time Frame

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)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

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 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Masataka Ota, MD

Organizational Affiliation

Merck Serono Co., Ltd., Japan

Official's Role

Study Director

Facility Information:

Facility Name

Please contact the Merck KGaA Communication Center located in

City

Darmstadt

Country

Germany

12. IPD Sharing Statement

Citations:

PubMed Identifier

33561262

Citation

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.

Results Reference

derived

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

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