NCT01396707

Trastuzumab in Combination With Capecitabine and Oxaliplatin(XELOX) in Patients With Advanced Gastric Cancer(AGC): Her+XELOX

A Phase II Study of Trastuzumab in Combination With Capecitabine and Oxaliplatin (XELOX) in Patients With Advanced Gastric Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: Asan Medical Center · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, multicentre, prospective phase II trial designed to evaluate the efficacy and safety of trastuzumab in combination with capecitabine and oxaliplatin as first-line therapy in patients with recurrent and/or metastatic HER2 positive adenocarcinoma of the stomach or gastro-oesophageal junction.

Detailed description

Patients will be administered 6 cycles of combination chemotherapy, unless withdrawn earlier due to unacceptable toxicity, disease progression, or consent withdrawal. Patients will continue to be treated with trastuzumab alone until disease progression, unacceptable toxicity or consent withdrawal after finishing a maximum 6 cycles of combination chemotherapy.

Conditions

• Metastatic or Recurrent Gastric Adenocarcinoma
• Her-2 Positive Gastric Cancer

Interventions

Type	Name	Description
DRUG	Herceptin+XELOX	Each 3-weekly cycle, with chemotherapy given for 6 cycles, and trastuzumab continued even after completion of the combination chemotherapy until disease progression * Trastuzumab: 8 mg/kg i.v. loading dose on day 1, followed by 6 mg/kg i.v.infusion every 3 weeks * Capecitabine: 1000 mg/m2 oral twice daily for 14 days every 3 weeks (from evening on day 1 to morning on day 15) * Oxaliplatin 130 mg/m2 i.v. on day 1

Timeline

• Start date: 2011-06-01
• Primary completion: 2018-11-01
• Completion: 2019-03-01
• First posted: 2011-07-19
• Last updated: 2020-01-07

Locations

1 site across 1 country: South Korea