NCT01736410

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

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

Summary

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

Conditions

• HER 2 Positive Advanced Gastric Cancer

Interventions

Type	Name	Description
DRUG	Trastuzumab, TS ONE, Cisplatin	The initial dose of cisplatin is fixed to be 60 mg/m2 and intravenously administered over 1 hour on day 1 of the cycle. TS-ONE is orally administered consecutive 14-day followed by 7-day rest. The initial standard dose of TS-ONE is determined based on the body surface area tabled below. Trastuzumab is intravenously administered with the loading dose of 8 mg/kg followed by HER2-positive advanced GC 21 years or older No prior regimen HER2 protein HER2/neu detection procedure Tissue from (Gastric) Cancer FISH method IHC method negative positive HER-2 negative HER-2 positive Eligible 0 / 1+ 2+ 3+ HER-2 positive Eligible HER-2 negative iii Protocol S1/CDDP/Her V1.3 dated 21 May 10 maintenance dose of 6mg/kg in day 1 of each cycle. The study treatments are repeated every 3 weeks. Study treatment can continue until PD, but cisplatin can be skipped or discontinued if patients experienced unbearable toxicity which comes from cisplatin.

Timeline

• Start date: 2010-05-01
• Primary completion: 2013-04-01
• Completion: 2013-05-01
• First posted: 2012-11-29
• Last updated: 2013-06-17

Locations

1 site across 1 country: Singapore