HER2 positive gastric cancer
Conditions
Interventions
Trastuzumab is given by intravenous infusion at a dose of 8 mg/kg on day 1 of the fi rst cycle, followed by 6 mg/kg every 3 weeks. Docetaxel is given by intravenous infusion at a dose of 60 mg/m2, fo
Sponsors
Tohoku Clinical Oncology, Research and Education Society(T-CORE)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patient with unresectable or recurrence gastric cancer which is pathologically comformed adenocarcinoma. 2. HER2 positive is confirmed from primary or metastatic tumor (HER2 positive is defined as HER2 (3+) by IHC or HER2 (2+) and FISH positive). 3. Patient who has recieved trasutuzumab containing treatment as first line and is refractory to trasutuzumab containig regimen. 4. One or more measurable lesions based on the RECIST (ver 1.1) and progressive disease after trasutuzumab containing treatment as first line are confirmed by CT or MRI before registration within 28 days. 5. At the time of starting the treatment, at least 28 days are passed since the last treatment of 1st line therapy. 6. No prior therapy of docetaxel containing regimen. 7. Age 20 years old or elder. 8. An Eastern Cooperative Oncology Group (ECOG) scale performance status of 0 - 2 9. Patient who has normal cardiac function : LVEF lower limit or more than 50% was confirmed by echocardiography or MUGA scan within 3 month before registration. 10. Written informed concent was obtained from the patients. 11. Adequate organ function defined by the following data within 14 days before registration. No transfusion and administration of hematopoietic factor are allowed within 2 weeks before examination: (1) WBC: 3,000-12,000/mm3 (2) Neutrophiles: 1,500/mm3 or more (3) Platelets: 75,000/mm3 or more (4) Hb: 8.0 g/dl or more (5) total bilirubin: upper limit or less than 2.0 mg/dl (6) AST(GOT) and ALT(GPT): 100 IU/L or less (in case with metastatic liver tumor, 200 IU/L or less) (7) serum creatinine: upper limit or less than 1.5mg/dl
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall response rate (ORR) | — |
Countries
Japan
Contacts
Public ContactMasanobu Takahashi
Tohoku Clinical Oncoogy, Research and Education Society(T-CORE) Administration Office
Outcome results
None listed