CPT-11 or weekly PTX and Trastuzumab for previously treated HER2 positive advanced gastric cancer -Phase II study
- Conditions
- previously treated HER2 positive advanced gastric cancer
- Registration Number
- JPRN-UMIN000006975
- Lead Sponsor
- SGCSG: Shimane Gastroenterological Cancer Study Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 33
Not provided
(1) Forbidden case to use CPT-11/PTX and Trastuzumab. (2) Baseline left ventricular ejection fraction (LVEF) is <50% measured by echocardiography or MUGA scan. (3) In the UGT1A1 allele, UGT1A1(*)6/(*)6 genotype or UGT1A1(*)28/(*)28 genotype UGT1A1(*)28/(*)6 genotype (4) R1 operation(histlogically positive PM, OM, LM, VM). (5) Infection or inflammatory case. (6) Severe heart disease. (7) Severe complicated case such as ileus, interstitial pneumonia, uncontrolled DM, liver cirrhosis etc. (8) Severe ascites and/or pleural effusion. (9) Multiple bone metastasis. (10) Clinical suspicion or previous history of metastasis to brain or meninges. (11) Difficulty to join the trial due to psychosis or psychotic symptoms or central nervous system damage. (12)Complicated other active cancer. (13)patient who want to be pregnant and /or pregnant woman. (14)Intend to make pregnant. (15)Active hepatitis type HBs positive. (16)No previous treatment(except adjuvant chemotherapy). (17)Otherwise determined by investigators or site principal investigators to be unsuitable for participation in study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method