A Phase 2 Study of Trastuzumab in Combination With TS-ONE and Cisplatin in Firstline Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Advanced Gastric Cancer

National Cancer Centre, Singapore1 site in 1 country30 target enrollmentMay 2010

Overview

To explore overall response rate of trastuzumab combined with TS-ONE based chemotherapy in first-line HER2-positive advanced gastric cancer.

Registry

clinicaltrials.gov

Start Date

May 2010

End Date

May 2013

Last Updated

12 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Sponsor

National Cancer Centre, Singapore

Responsible Party

Principal Investigator

Choo Su Pin

Doctor

National Cancer Centre, Singapore

•Patients must have histologically or cytologically confirmed adenocarcinoma of the stomach and Gastric-esophageal junction.
•Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as more than or equals to 20 mm with conventional techniques or as more than or equals to 10 mm with spiral CT scan.
•Patients without prior systemic treatment. Patients who completed postoperative adjuvant chemotherapy (and radiotherapy) more than 180 days before may be enrolled.
•Age more than or equals to 21 years.
•Life expectancy of greater than 3 months.
•ECOG performance status less than or equals to 2 (Karnofsky more than or equals to 60%).
•Patients must have normal organ and marrow function as defined below:
•Hemoglobin \> 8.0 g/dL
•Leukocytes \> 3,000/mcL
•Absolute neutrophil count \> 1,500/mcL

•Patients who have had radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to treatment administered more than 4 weeks earlier.
•Patients receiving any other investigational agents.
•Patients with known brain metastases.
•History of allergic reactions attributed to compounds of similar chemical or biologic composition to TS-ONE, cisplatin and trastuzumab or other agents used in the study.
•Presence of any contraindications to TS-ONE or cisplatin or trastuzumab.
•Baseline LVEF (Left Ventricular Ejection Fraction) \< 50%.
•Patients with serious (e.g.inpatient care is needed) complications (e.g. intestinal paralysis, intestinal occlusion, interstitial pneumonia or pulmonary fibrosis, poorly-controlled diabetes, renal failure or hepatic cirrhosis).
•Patients with massive ascites (moderate or higher, beyond the pelvic cavity and retention on the anterior surface of the liver on CT) or massive pleural effusion retention.
•Patients with fresh bleeding from the digestive tract which needs repeated blood transfusion.
•Patients with diarrhea (4 or more times per day or watery diarrhea).