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

September 9, 2013 updated by: Merck KGaA, Darmstadt, Germany

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Darmstadt, Germany
        • Please contact the Merck KGaA Communication Center located in

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cetuximab plus cisplatin plus S-1
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Best Overall Response (BOR) Rate - Independent Review Committee (IRC) Assessments
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)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Median Progression-free Survival (PFS) Time - Independent Review Committee (IRC) Assessments
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)
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.
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck KGaA, Darmstadt, Germany

Investigators

  • Study Director: Masataka Ota, MD, Merck Serono Co., Ltd., Japan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (Actual)

August 1, 2012

Study Completion (Actual)

May 1, 2013

Study Registration Dates

First Submitted

June 24, 2011

First Submitted That Met QC Criteria

July 5, 2011

First Posted (Estimate)

July 7, 2011

Study Record Updates

Last Update Posted (Estimate)

November 20, 2013

Last Update Submitted That Met QC Criteria

September 9, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EMR 062202-058

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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