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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

Phase 2
20 Years
Open (Enrolling)
Gastric Cancer

Thank you

Trial Information

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

Inclusion Criteria:

1. Written informed consent which was approved by the Institutional Review Board (IRB)
of the site before any trial-related activities are carried out

2. Age ≥ 20 years

3. Histologically confirmed adenocarcinoma of the stomach or GEJ (adenocarcinomas of the
esophagogastric junction types I to III according to Siewert's classification)

4. Archived tumor material sample for at least subsequent standardized epidermal growth
factor receptor (EGFR) expression and Kirsten-rat sarcoma (KRAS) mutation assessments
Investigators must make sure in advance that appropriate archived tumor material is
available from a potentially eligible subject, and that a sample can be shipped to a
central repository if the subject agrees to participate.

5. Unresectable advanced (M0) or unresectable metastatic (M1) disease For unresectable
advanced disease (M0), at least one measurable locoregional lymph node or other
measurable extraluminal tumor lesion ≥ 20 mm (independent of whether measured by
conventional techniques or spiral computed tomography [CT] scan) must be documented.

6. At least one radiographically documented measurable lesion in a previously
non-irradiated area according to the RECIST version 1.0, i.e., this lesion must be
adequately measurable in at least one dimension (longest diameter [LD] to be
recorded) as ≥ 20 mm by conventional techniques or ≥ 10 mm by spiral CT scan. Primary
tumor site will be considered as a non-measurable lesion only.

7. Eastern Cooperative Oncology Group - performance status (ECOG-PS) 0 to 1

8. Estimated life expectancy > 12 weeks

9. Medically accepted contraception (in patients with conception potential)

10. Glomerular filtration rate (GFR) ≥ 60 mL/min (estimated by the Cockcroft-Gault

11. Aspartate Aminotransferase (AST) ≤ 2.5 x upper limit of normal (ULN) and Alanine
Aminotransferase (ALT) ≤ 2.5 x ULN (or AST ≤ 5.0 x ULN and ALT ≤ 5.0 x ULN in
patients with liver metastasis)

12. Bilirubin ≤ 3 x ULN

13. Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L

14. Platelets ≥ 100 x 10^9/L

15. Hemoglobin ≥ 9.0 g/dL (without transfusions)

16. Sodium and potassium within normal limits or ≤ 10% above or below (supplementation

17. Japanese (with Japanese citizenship)

Exclusion Criteria:

1. Prior chemotherapy. However previous (neo-)adjuvant (radio-)chemotherapy allowed if
finished > 1 year prior to start of trial treatment and no more than 300 mg/m^2
cisplatin has been administered

2. Prior treatment with an antibody or molecule targeting EGFR- and/or vascular
endothelial growth factor (VEGF) receptor-related signaling pathways

3. Brain metastasis and/or leptomeningeal disease (known or suspected)

4. Radiotherapy (except localized radiotherapy for pain relief), major surgery, or any
investigational drug in the 30 days before the start of trial treatment

5. Concurrent chronic systemic immune or hormone therapy not indicated in this trial
protocol except for physiologic replacement

6. 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

7. 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)

8. Chronic diarrhea or short bowel syndrome

9. Presence of any contraindication to treatment with cetuximab and SP including:

- Known hypersensitivity to S-1, fluorouracil, cisplatin, cetuximab or to any of
the excipients of these drugs

- Known dihydropyrimidine dehydrogenase deficiency

- Hereditary problems of galactose intolerance, the Lapp lactase deficiency or
glucose-galactose malabsorption

- Current treatment with sorivudine or its chemically related analogues, such as

- Continuous treatment with flucytosine (based on the S-1 package insert)

- Symptomatic peripheral neuropathy of Grade ≥ 2 and/or ototoxicity of Grade ≥ 2
according to National Cancer Institute - Common Toxicity Criteria for Adverse
Events (NCI-CTCAE) version 3.0, except if due to trauma or mechanical impairment
due to tumor mass

10. Pregnancy or lactation period

11. Concurrent treatment with a non-permitted drug (any other chemotherapy, systemic
anticancer therapy or immunotherapy)

12. Previous malignancy other than gastric cancer in the last 5 years except basal cell
cancer of the skin, preinvasive cancer of the cervix, and carcinoma in situ of the
digestive tract

13. Medical or psychological conditions that would not permit the patient to complete the
trial or sign the Informed Consent Form (ICF)

14. Legal incapacity or limited legal capacity

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Best Overall Response (BOR) assessed by the Independent Review Committee (IRC) according to the Response Evaluation Criteria in Solid Tumors (RECIST)

Outcome Description:

The best overall response rate is defined as the proportion of subjects having achieved confirmed Complete Response + Partial Response as the best overall response according to radiological assessments (based on RECIST criteria).

Outcome Time Frame:

Evaluations were performed every 6 weeks until progression, reported between first day patient treated, Jul 2011, until cut-off date, (anticipated Jun 2012)

Safety Issue:


Principal Investigator

Masataka Ota, MD

Investigator Role:

Study Director

Investigator Affiliation:

Merck Serono Co., Ltd., Japan


Japan: Pharmaceuticals and Medical Devices Agency

Study ID:

EMR 062202-058



Start Date:

June 2011

Completion Date:

June 2013

Related Keywords:

  • Gastric Cancer
  • Gastric Cancer
  • Cetuximab
  • EMD271786
  • TS-1
  • Cisplatin
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Stomach Neoplasms