Advanced / Recurrent gastric cancer.
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. histologically proven gastric carcinoma 2. patients who received TS-1 or CPT-11 as a prior chemotherapy and enough treatment free period (TS-1: 2weeks, CPT-11: 2weeks) 3. with measurable lesions 4. age: 20<= years old 5. PS(ECOG): 0 &#8211; 2 6. without any other severe diseases WBC 3,000<= Neutrocyte 1,500mm3<= Hemoglobin 9.0 g.dl <= Platelet 100,000/mm3 <= Total bilirubin 1.5 mg/dl => AST, ALT within five times of normal range in each institute Serum creatinin 1.5 mg/dl >= ECG normal range 7. expected survival period: longer than 3 months 8. written informed consents
Exclusion criteria
Exclusion criteria: 1. cavity fluid which should be taken out 2. with double cancer and/or multiple cancer 3. patients with disorders on peripheral nerves 4. with active infectious disease which needs treatment 5. under the condition of diarrhea 6. with some mental and/or neural disorder which disturbs registration 7. under continuous steroids therapy 8. with other severe diseases(intestinal paralysis, intestinal obstruction, uncontrolled DM, pulmonary fibrosis, cardiac failure, or liver dysfunction) 9. pregnant and/or nursing women 10.with allergic history against medicines 11.with severe allergic response against medicine including cremoful 12.under Docetaxel or Paclitaxel therapy 13.doctors' stop not to register to the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| feasibility of the treatment (ratio of completion) | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of adverse events, Response Rate,Time to treatment failure,Progression free survival, Overall survival | — |
Countries
Japan
Contacts
Sakai City Hospital Director