Advanced or recurrent gastric cancer
Conditions
Interventions
In the 1st course, ABI is administered 180mg/m2 intravenously for 30 minutes on day 1 of 3-week period. In the 2nd and 3rd course, dose of ABI is modified by the frequency and severity of neutropenia
Sponsors
Graduate School of Medical Science, Kumamoto Universit
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically confirmed gastric cancer (adenocarcinoma) 2) Stage IV with evaluable lesion 3) Age of 20 years or older 4) Performance status: 0-1 5) Received Standard treatment as 1st line therapy (containing recurrent within 6 months after adjuvant chemotherapy) 6) Not received treatment (chemotherapy, immunotherapy, or radiation therapy) other than 5) 7) Adequate organ function 8) Expected survival period of more than 3 months 10) Written informed consent to participate
Exclusion criteria
Exclusion criteria: 1) Severe bone marrow suppression 2) Complicated by infection 3) History of hypersensitivity to ABI, PAC or albumin 4) History of serious hypersensitivity 5) Pregnant or nursing woman 6) Significant abnormal electrocardiogram or heart disease to be clinically relevant 7) Pleural effusion or ascites in need of treatment 8) Brain metastases 9) Active double cancer (synchronous double cancer or metachronous double cancer with a disease-free interval of less than five years; carcinoma in situ judged to be cured by local treatment are not considered to be active double cancers) 10) Peripheral neuropathy which were graded 2 or higher 11) Interstitial pneumonia or pulmonary fibrosis 12) HBs antigen or HCV antibody positive 13) Physician concludes that the patient's participation in this trial is inappropriate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Adversed Event Response Rate Overall Survival Time to Treatment Failure Relative Dose Intensity | — |
Countries
Japan
Contacts
Public ContactMasaaki IWATSUKI
Graduate School of Medical Science, Kumamoto University Department of Gastroenterological Surgery
Outcome results
None listed