Phase I/II study of HB-EGF-specific inhibitor BK-UM plus weekly paclitaxel therapy in gastric cancer with peritoneal metastasis after failure of first line treatment.
- Conditions
- advanced and/or recurrent gastric cancer with peritoneal metastasis
- Registration Number
- JPRN-UMIN000015812
- Lead Sponsor
- Kyushu University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 42
Not provided
1)Patients who have serious illness or suspect to have serious illness. 2)Patients with serious drug hypersensitivity. 3)Pregnant women, nursing mothers, or patients with chance of pregnancy. 4)Patients with a history of antiserum use 5)Patients with HBsAg-positive or HCVAb-positive. 6)Patients with a history of taxane use. 7)Patients with symptomatic central nervous system metastasis. 8)Patients with large amounts of pleural effusion. 9)Patients with chemotherapy untreatable large amounts ascites. 10)Patient with synchronous or metachronous malignancies within 5 years. 11)Patients within 14 days from prior chemotherapy on the first treatment day. 12)Patients who received the blood transfusion within 21 day from registration. 13)Patients who received the other investigational drug 28 days before agreement. 14)Patients have received BK-UM treatment. 15)Patients who is judged inappropriate for the entry into this study by the principal investigator or sub investigators.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method One-year progression-free survival
- Secondary Outcome Measures
Name Time Method 1)response rate 2)Exploration of biomarker predicting treatment response 3)Safty