NCT01228045

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

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: National University Hospital, Singapore · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

The investigators hypothesis is that the combination of TS-ONE with cisplatin and trastuzumab is safe and as effective as combination treatment for HER2 positive gastric cancer.

Detailed description

Gastric carcinoma is the second most common cause of cancer death world-wide. Approximately 875,000 patients are diagnosed world-wide with gastric cancer each year. Gastric cancer is often diagnosed at an advanced stage1. At diagnosis, while some patients have gastric carcinoma that extends within loco-regional confines and can undergo a curative resection, many patients cannot undergo curative resection. Gastric cancer continues to pose a major medical challenge. While advanced gastric carcinoma is incurable, chemotherapy can have a palliative effect in symptomatic patients. Chemotherapy improves outcome compared to best supportive care in gastric cancer. Various chemotherapeutic agents including 5-FU, mitomycin, etoposide, cisplatin, irinotecan and the taxanes, have demonstrated activity as monotherapy. Combination chemotherapy has been shown to have better survival outcomes than single agent chemotherapy Standard chemotherapy for advanced gastric carcinoma includes a fluoropyrimidine and platinum -based combination chemotherapy.

Conditions

• Gastric Cancer

Interventions

Type	Name	Description
DRUG	Trastuzumab in Combination with TS-ONE and cisplatin	Subjects will receive treatment that combined TS-ONE, cisplatin and trastuzumab every 3 weeks in this study. This 3 weeks period of time is called a cycle. The cycle will be repeated until subject experience disease progression or unbearable toxicities or they choose to withdraw from the study. Each cycle is numbered in order.

Timeline

• Start date: 2011-02-01
• Primary completion: 2014-12-01
• Completion: 2016-12-01
• First posted: 2010-10-25
• Last updated: 2016-06-22

Locations

1 site across 1 country: Singapore