Phase II trial of trasutuzumab plus docetaxel for previous trastuzumab treated unresectable or recurrent HER2 positive gastric cancer (T-CORE1203)
- Conditions
- HER2 positive gastric cancer
- Registration Number
- JPRN-UMIN000010869
- Lead Sponsor
- Tohoku Clinical Oncology, Research and Education Society(T-CORE)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 27
Not provided
1. Patient who has active double cancer (excluding carcinoma in situ and skin cancer which were cured, and GI tract cancer in which curable operation was carried out by EMR) 2. Patient who has severe or uncontrolled complication (infection, pulmonary fibrosis, paralytic intestine, bowel obstruction, uncontrolled diabetes mellitus, liver cirrhosis, uncontrolled hypertension, myocardiac infarction or unstable angina within 1 year before registration). 3.Active (significant or uncontrolled) bleeding from GI tract. 4.Patient who needs drainage of peritoneal, pleural or pericardial effusion. 5.Contraindication against trasutuzumab and docetaxel. 6.Women who is pregnancy, possible pregnancy or lactation and patients who wish their partner to become pregnant. 7.Attending physician determines that the case was inappropriate as the subject of this study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall response rate (ORR)
- Secondary Outcome Measures
Name Time Method