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Phase 2
21 Years
Open (Enrolling)
Gastric Cancer

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Trial Information

Inclusion Criteria:

1. Patients with histologically proved adenocarcinoma of advanced gastric cancer.

2. Patients who have HER2-positive cancer confirmed with IHC and/or FISH.

3. Patients with proved presence of measurable (RECIST criteria) lesions within 28 days
before enrollment.

4. Patients without prior treatment (ex. radiotherapy, chemotherapy, hormonal therapy):
Patients who completed adjuvant chemotherapy more than 180 days before may be
enrolled but those who received TS-ONE or cisplatin shall be excluded.

5. Patients with the following function of bone marrow, liver and kidney based on the
laboratory tests measured within 14 days before enrollment. Hemoglobin >= 8.0 g/dL
leukocytes >=3,000/mcL absolute neutrophil count >=1,500/mcL platelets >=100,000/mcL
total bilirubin within normal institutional limits AST(SGOT)/ALT(SGPT)=<2.5 X
institutional upper limit of normal ALP < twice of the upper limit of normal,
creatinine within normal institutional limits or creatinine clearance >=60 mL/min for
patients with creatinine levels above institutional normal (When AST(GOT), ALT(GPT)
and ALP do not satisfy the conditions above and these values are considered to be
caused by cancer, the decision is based on the discretion of investigators or
co-investigators) Creatinine clearance can be estimated using Cockcroft-Gault formula
man: Ccr (mL/min) = body weight (kg) x (140 - age)/(72 x serum creatinine (mg/dL)),
woman: Ccr = male Ccr x 0.85].

6. ECOG performance status =<2 (Karnofsky >60%; see Appendix A).

7. Patients who are expected to survive more than 3 months after enrollment.

8. Age >= 21.

9. Patients of adequate oral intake.

10. Patients who underwent electrocardiography within 28 days before enrollment.\

11. Patients who give written informed consent for additional endoscopy to obtain fresh
frozen tissue biopsies for translational studies at 2 time points pre-1st cycle of
chemotherapy and at progression.

12. Patients who give written informed consent for enrollment into trial.

Exclusion Criteria:

1. Patients for whom TS-ONE or cisplatin or trastuzumab is contraindicated.

2. History of allergic reactions attributed to compounds of similar chemical or biologic
composition to TS-ONE, cisplatin and trastuzumab.

3. Patients receiving any other investigational agents.

4. Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance with
study requirements.

5. Baseline heart function LVEF (Left Ventricular Ejection Fraction) < 50%.

6. Patients with serious (ex. inpatient care is needed) complications (ex. intestinal
paralysis, intestinal occlusion, interstitial pneumonia or pulmonary fibrosis,
poorly-controlled diabetes, renal failure or hepatic cirrhosis).

7. Patients with massive ascites (moderate or higher, beyond the pelvic cavity and
retention on the anterior surface of the liver on CT) or pleural effusion retention.

8. Patients with extensive bone metastasis.

9. Patients with known brain metastases.

10. Patients with fresh bleeding from the digestive tract which needs repeated blood

11. Patients with diarrhea (4 or more times per day or watery diarrhea).

12. Patients with simultaneously active multiple cancer.

13. Pregnant or lactating female.

14. Patients with reproductive potential who refuse to use an adequate means of
contraception (including male patients).

15. Other patients evaluated to be inadequate to participate in the study by

16. No informed consent for either treatment regimen or collection of fresh frozen biopsy
tissue for translational studies.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Primary Purpose: Treatment


Singapore: Domain Specific Review Boards

Study ID:




Start Date:

February 2011

Completion Date:

Related Keywords:

  • Gastric Cancer
  • Patients with histologically proved adenocarcinoma of advanced gastric cancer
  • Stomach Neoplasms