NCT03766607

Trastuzumab Beyond Progression in HER2 Positive Metastatic Gastric Cancer

A Multi-center Phase II Study of Trastuzumab Biosimilar (SB3®) in Combination With Ramucirumab and Paclitaxel in HER2 Positive Metastatic Gastric Cancer Patients

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Korean South West Oncology Group · Network
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to evaluate the efficacy and safety of combination therapy with ramucirumab, paclitaxel, and trastuzumab biosimilar as second line treatment of HER2 positive metastatic gastric cancer after failure of first line chemotherapy including trastuzumab. This study is a phase II, single-arm, open label, multi-center study.

Detailed description

Approximately 15% of patients with advanced gastric cancer have HER2 overexpression and the combined use of trastuzumab and other cytotoxic chemotherapeutic agents, such as 5-FU and cisplatin, in these patients is associated with a significantly improved survival rate compared with cytotoxic chemotherapy alone. So, the combination of trastuzumab and chemotherapy is currently being used as a standard treatment in HER2 positive advanced gastric or gastroesophageal adenocarcinoma. However, after failing first line treatment with such regimen, second line treatment is determined regardless of HER2 status, and the most preferred treatment is ramucirumab and paclitaxel combination chemotherapy. Recently, the use of trastuzumab in combination with other cytotoxic chemotherapeutic agents has been reported to be superior to the use of cytotoxic chemotherapy alone in the treatment of patients with HER2 positive metastatic breast cancer. On the basis of several guidelines, it is recommended to extend the use of trastuzumab after disease progression. In addition, in some retrospective studies of metastatic gastric cancer, it has been reported that treatment with trastuzumab in combination with second line chemotherapy followed by first line chemotherapy including trastuzumab is beneficial and it is worthwhile to be tested in the prospective study. Furthermore, data on the safety and efficacy of cross-administration of trastuzumab biosimilar have not been available yet.

Conditions

• Gastric Cancer

Interventions

Type	Name	Description
DRUG	Trastuzumab	Trastuzumab (8 mg/kg loading dose; 6 mg/kg maintenance) administered intravenously every 21 days
DRUG	Ramucirumab	Ramucirumab 8 mg/kg administered intravenously on days 1 and 15 every 28 days
DRUG	Paclitaxel	Paclitaxel 80 mg/m2 administered intravenously on days 1, 8, and 15 every 28 days

Timeline

• Start date: 2019-09-30
• Primary completion: 2021-12-31
• Completion: 2022-06-30
• First posted: 2018-12-06
• Last updated: 2019-09-19

Locations

1 site across 1 country: South Korea