Phase I/II study of Paclitaxel+Trastuzumab therapy in 2nd line treatment for advanced or recurrent gastric cancer with HER2 positive.
- Conditions
- HER2-positive gastric cancer
- Registration Number
- JPRN-UMIN000011863
- Lead Sponsor
- Osaka Medical College Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 100
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Phase I:Maximum tolerated dose and recommended dose Phase II:Response Rate(RR)
- Secondary Outcome Measures
Name Time Method Phase I:Response Rate (RR), Incidence and degree of adverse events Phase II:Progression free survival (PFS), Overall survival (OS), Incidence of adverse events