advanced and/or recurrent gastric cancer with peritoneal metastasis
Conditions
Interventions
BK-UM+Paclitaxel
Sponsors
Kyushu University Hospital
The research foundation for Microbial Diseases of Osaka University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Patients with histologically proven gastric adenocarcinoma. 2)Patients with unresectable gastric cancer or recurrent gastric cancer. 3)Patients with peritoneal metastasis. 4)ECOG performance status: 0-2 grade. 5)Patients with satisfy any or all of the following items. 1.Tumor progression during 5-FU contained adjuvant chemotherapy or within 24 weeks after adjuvant chemotherapy. 2.Tumor progression during 5-FU contained chemotherapy or within 4 weeks after prior chemotherapy which continued at least 4 weeks. 6)Patients who can place a port into the abdominal cavity. 7)Patients with following adequate organ function. 1.WBC: >= 3,000/ mm3 Neutrophil: >= 1,000/ mm3 <=12,000/ mm3 2.Platelet: >= 100,000/ mm3 3.Hemoglobin: >= 8.0 g/dL 4.AST, ALT: <=100 IU/mL 5.Total biirubin: <=1.5 mg/dL 6.Serum creatinine: <=1.5 mg/dL 7.serum creatinine <=1.5 mg/dL 8.CRP <=10mg/dL 9.Patient without cardiovascular disease requiring continuous treatment. 10.Patient without the neuropathy more than grade 3. 8)Age:20 years old or older, and under 75 years old. 9)Patients without the prior of chemotherapy or the radiotherapy for other malignant disease. 10)Patients who agree with attend this clinical trial by their own will.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| One-year progression-free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| 1)response rate 2)Exploration of biomarker predicting treatment response 3)Safty | — |
Countries
Japan
Contacts
Public ContactMakiko Uchiyama
Kyusyu University Center for Clinical and Translational Research
Outcome results
None listed