HER2-positive gastric cancer
Conditions
Interventions
Trastuzumab:8mg/kg(i.v.) for the initial dosing and 6mg/kg for subsequent administration. Trastuzumab administered at day 1. Paclitaxel:80-100mg/m2 administered at day 1 and day 8. One course lasts
Sponsors
Osaka Medical College Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Histological confirmed adenocarcinoma; papillary, tubular, poorly, signet ring cell, mucinous, or hepatoid 2)Unresectable advanced or recurrent gastric cancer 3)with measurable lesions 4)Able or unable to eat or drink 5)Age over 20 years old and under 80 6)PS(ECOG) between 0 and 1 7)HER2 positive 8)No previous chemotherapy of Paclitaxel 9)Without any brain metastasis 10)With a good condition of important organs within 14 days of registration a)Neutrophil>=2,000/mm3 b)Platelet>=100,000/mm3 c)Total bilirubin<=1.5mg/dL d)Hemoglobin>=8.0g/dL e)AST<=100IU/L, or AST<=200IU/L with liver metastases f)ALT<=100IU/L, or ALT<=200IU/L with liver metastases g)Serum creatinine<=1.2mg/dL 11)Written informed consent to participate in this study
Exclusion criteria
Exclusion criteria: 1)With active double cancers whose disease free period is within 5 years. Carcinoma in situ can be excluded. 2)With a history of severe allergy against medicine. 3)With severe diarrhea (more than 4 times/day) or watery stool 4)With body temperature over 38 degrees Celsius and/or infectious disease which needs therapy. 5)With severe myelo-dysfunction, renal dysfunction and/or liver dysfunction. 6)With other severe diseases a)Interstitial pneumonitis, pulmonary fibrosis or severe emphysema b)Renal dysfunction c)Liver dysfunction d)Intestinal paralysis, ileus e)Jaundice f)Uncontrolled DM 7)Serious illness or medical conditions as defined below, a)Patients with a previous history of congestive heart failure b)Unstable angina requiring medication c)Patients with a previous history of transmural infarct d)Uncontrolled hypertension e)Severe heart valve diseases f)Hi-risk uncontrolled arrhythmias g)Patients with left ventricular ejection fraction in the baseline is less than 50% on MUGA (Multi Gated Acquisition Scan) or echocardiography. 8)with HBs(+) 9)Patients whom administered Flucitosine or Athazanavil sulfate 10)Patients whom administered Fenitoin and/or Warfarin 11)General administration of steroids 12)Woman who are pregnant or expect to be pregnant or nursing female 13)Patients whom doctor in chief decides not to register to this study due to psychological disease or symptoms 14)Patients whom doctor in chief decides not to register to this study due to other reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase I:Maximum tolerated dose and recommended dose Phase II:Response Rate(RR) | — |
Secondary
| Measure | Time frame |
|---|---|
| Phase I:Response Rate (RR), Incidence and degree of adverse events Phase II:Progression free survival (PFS), Overall survival (OS), Incidence of adverse events | — |
Countries
Japan
Contacts
Public ContactMasahiro Goto
Osaka Medical College Hospital Cancer Chemotherapy Cancter
Outcome results
None listed