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

Asan Medical Center1 site in 1 country55 target enrollmentJune 2011

ConditionsMetastatic or Recurrent Gastric Adenocarcinoma Her-2 Positive Gastric Cancer

InterventionsHerceptin+XELOX

DrugsHerceptin+XELOX

Overview

Phase: Phase 2
Intervention: Herceptin+XELOX
Conditions: Metastatic or Recurrent Gastric Adenocarcinoma
Sponsor: Asan Medical Center
Enrollment: 55
Locations: 1
Primary Endpoint: Overall response rate
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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Patients will be administered 6 cycles of combination chemotherapy, unless withdrawn earlier due to unacceptable toxicity, disease progression, or consent withdrawal.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.

Registry

clinicaltrials.gov

Start Date

June 2011

End Date

March 2019

Last Updated

6 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Asan Medical Center

Responsible Party

Principal Investigator

Yoon-Koo Kang

Professor

Asan Medical Center

Eligibility Criteria

Inclusion Criteria

•Histologically confirmed adenocarcinoma of the stomach or gastro-oesophageal junction with inoperable locally advanced or recurrent and/or metastatic disease, not amenable to curative therapy.
•Measurable disease, according to the Response Evaluation Criteria in Solid Tumors (RECIST), assessed using imaging techniques (CT or MRI).
•HER2 positive tumour (primary tumour or metastasis) defined as either IHC2+ and FISH+ or IHC3+ according to the gastric cancer scoring system for HER2
•ECOG Performance status 0, 1 or 2
•Life expectancy of at least 3 months.
•Male or female. Age over 20 year.
•Signed informed consent.

Exclusion Criteria

•Previous chemotherapy for advanced/metastatic disease (prior adjuvant/neoadjuvant therapy is allowed if at least 6 months has elapsed between completion of adjuvant/neoadjuvant therapy and enrolment into the study; adjuvant/neoadjuvant therapy with platinum is not allowed).
•Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome (e.g. patients with partial or total gastrectomy can enter the study, but not those with a jejunostomy tube).
•Patients with active (significant or uncontrolled) gastrointestinal bleeding.
•Residual relevant toxicity resulting from previous therapy (with the exception of alopecia), e.g. neurological toxicity over grade 2 NCI-CTCAE.
•Other malignancy within the last 5 years, except for carcinoma in situ of the cervix, or basal cell carcinoma.
•Neutrophil count \< 1.5 × 109/L, or platelet count \< 100 × 109/L.
•Serum bilirubin \> 1.5 × upper limit of normal (ULN); or, AST or ALT \> 2.5 × ULN (or \> 5 × ULN in patients with liver metastases); or, alkaline phosphatase \> 2.5 × ULN (or \> 5 × ULN in patients with liver metastases, or \> 10 × ULN in patients with bone but no liver metastases); or, albumin \< 25 g/L.
•Creatinine clearance \< 60 mL/min. Other Study Drug-Related Exclusion Criteria
•History of documented congestive heart failure; angina pectoris requiring medication; evidence of transmural myocardial infarction on ECG; poorly controlled hypertension (systolic BP \> 180 mmHg or diastolic BP \> 100 mmHg); clinically significant valvular heart disease; or high risk uncontrollable arrhythmias.
•Baseline LVEF \< 50% (measured by echocardiography or MUGA).