advanced or recurrent HER2-positive gastric cancer
Conditions
Interventions
Trastuzumab : 8 mg/kg(i.v.) for the initial dosing and 6 mg/kg for subsequent administration. Trastuzumab administration will be repeated every 3 weeks. Paclitaxel : 80 mg/m2 administered weekly
Sponsors
The Cancer Institute Hospital of JFCR
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histological confirmation of gastric cancer (included with CTC) . 2) History of chemotherapy must be contain 5-fluoropyrimidine 3) Case with Measurable lesion. 4) HER2 positive (IHC 3+ or IHC 2+ /FISH +) 5) Age: 20 years or older 6) performance status (PS): 0 - 2. Eastern Cooperative Oncology Group (ECOG) 7) Adequate organ function as follows: Neutrophils>=1500/mm3 Hemoglobin>=9.0 g/dl Platelets>=100,000/mm3 Total bilirubin>=upper limit of normal (ULN)*1.5 AST and ALT <= upper limit of normal (ULN)*2.5 (<=ULN*5 in case of liver metastasis) 8) LVEF of >= 50% on echocardiography 9) Written informed consent.
Exclusion criteria
Exclusion criteria: 1) Patient with a previous history of serious drug hypersensitivity. . 2) Patient with infectious diseases associated with a fever of 38.0 degrees C or higher 3) Patient with serious complications (interstitial pneumonia or pulmonary fibrosis, difficult-to-control diabetes, renal failure, hepatic failure, and so on) 4) Patient who has heart disease(CHF, old MI, IHD, arrhythmia, and a valvular disease of the heart) 5) Poorly-controlled hypertension 6) Patient with synchronous double cancer or metachronous double cancer with a disease-free interval of less than five years(In-situ cancer, gastric cancer, mucosal cancer, differentiated adenocarcinoma, and skin cancer judged to be cured by treatment are not considered to be active double cancers.) 7) Women of child-bearing potential (intention), pregnant or lactating women 8) Men desiring to have children 9) Patient judged by the investigator(s) to be inappropriate study participants for any other reason
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety ORR:overall response rate Progression free survival rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety PFS: progression free survival OS: overall survival TTP: Time to treatment failure Prediction of effects based on the number of CTCs and PAC+T therapy Prediction of effects based on markers on CTCs and PAC+T therapy | — |
Countries
Japan
Contacts
Public ContactSatoshi Matsusaka
The Cancer Institute Hospital of JFCR Gastroenterology
Outcome results
None listed