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A Phase II Study of S-1 Combined With Irinotecan and Oxaliplatin in Recurrent or Metastatic Gastric Carcinoma

Phase 2
18 Years
Not Enrolling
Stomach Neoplasms

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Trial Information

A Phase II Study of S-1 Combined With Irinotecan and Oxaliplatin in Recurrent or Metastatic Gastric Carcinoma

Inclusion Criteria:

1. Histologically or cytologically confirmed gastric adenocarcinoma with recurrent or
metastatic disease

2. Age ≥18 years

3. Eastern Cooperative Oncology Group (ECOG) performance status 0-2

4. Disease status must be that of measurable disease as defined by RECIST
criteria:Measurable lesions: Lesions that can be accurately measured in at least one
dimension by any of the following: - CT of abdomen, pelvis or thorax, if the longest
diameter to be recorded is at least 10 mm with spiral CT- Chest x-ray, if the lung
lesion to be recorded is clearly defined and surrounded by aerated lung and the
diameter to be recorded is at least 20 mm- Physical examination, if the clinically
detected lesions are superficial (e.g., skin nodule and palpable lymph nodes) and at
least 10 mm

5. No prior treatment for recurrent or metastatic disease; prior adjuvant/neoadjuvant
therapy is allowed if at least 12 months have elapsed between completion of
adjuvant/neoadjuvant therapy and enrolment into the study. However, prior oxaliplatin
and/or irinotecan as adjuvant therapy are not allowed.

6. Adequate major organ function including the following: Hematopoietic function: ANC ³
1,500/mm3, Platelet ³ 100,000/mm3Hepatic function: serum bilirubin 1.5 mg/dl,
AST/ALT levels 2.5 x UNL ( 5 x UNL if liver metastases are present)Renal function:
serum creatinine UNL

7. Patients should sign a written informed consent before study entry

Exclusion Criteria:

1. Prior history of peripheral neuropathy

2. Inadequate cardiovascular function:New York Heart Association class III or IV heart
diseaseUnstable angina or myocardial infarction within the past 6 monthsHistory of
significant ventricular arrhythmia requiring medication with antiarrhythmics or
significant conduction system abnormality

3. Serious concurrent infection or nonmalignant illness that is uncontrolled or whose
control may be jeopardized by complications of study therapy

4. Other malignancy within the past 3 years except non-melanomatous skin cancer or
carcinoma in situ of the cervix

5. Psychiatric disorder that would preclude compliance

6. Pregnant, nursing women or patients with reproductive potential without contraception

7. Patients receiving a concomitant treatment with drugs interacting with S-1 such as

Type of Study:


Study Design:

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

Outcome Measure:

Maximal overall response rate

Outcome Time Frame:

During chemotherapy

Safety Issue:


Principal Investigator

Sook Ryun Park, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Cancer Center, Korea


Korea: Food and Drug Administration

Study ID:




Start Date:

July 2007

Completion Date:

July 2009

Related Keywords:

  • Stomach Neoplasms
  • Stomach Neoplasms
  • Secondary
  • Combination chemotherapy
  • S-1
  • irinotecan
  • oxaliplatin
  • Neoplasms
  • Stomach Neoplasms