advanced and/or metastatic gastric cancer
Conditions
Interventions
Administration of medicines One course takes 5 weeks (35 days): TS-1 (80 mg/m2) is administrated orally 3 weeks followed by 2 weeks rest. CDDP(30mg/m2) and PTX(70mg/m2) are administered intravenous
Sponsors
OGSG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histologically proven colon cancer or rectal cancer 2. with measurable lesions for RECIST criteria 3. without prior therapy (Radiation therapy, chemotherapy, hormone therapy). Eligible if patient was completed prior therapy 4 weeks before start of this therapy 4. Functions of important organs are within normal range: <1> Hb : >= 8.0 g/dL <2> WBC : 4000-12000 /mm3 <3> Neutro. : >=2000mm3 <4> Platelet : >=10x104/mm3 <5> totl bil. : <=1.5mg/dL <6> AST,ALT : <100 IU/L Eligible <= 150 IU/L due to liver metastasis <7> sCr : <=1.2 mg/dL <8> CCr : >=60mL/min calculated by Cockcraft-Gault mathod 5. Performance Status (ECOG): 0-2 6. expected survival; >= 3 months 7. age: 20-75 years old 8. with ability of oral intake 9. Written informed consent to participate in this study
Exclusion criteria
Exclusion criteria: 1. with fresh bleeding from digestive tract 2. without ability of oral intake due to digestive tract obstruction 3. with history of severe allergy against medicine, especially, Medicines including Polyethylene-caster oil 4. with ascites and/or pleural fluid 5. with severe diseases (infectious diseases, interstitial pneumonia, Pulmonary fibrosis, cardiac dysfunction, renal dysfunction, liver dysfunction, uncontrolled DM etc) 6. with liver cirrhosis and/or jaundice 7. under treatment using psychotrophic agents or with a disease which needs psychological treatment 8. with some symptoms due to brain metastasis 9. with active double cancer 10. pregnant or nursing lady or lady with expectation of pregnancy 11. Any other patient whom the physician in charge of the study judges to be not eligible
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum concentration of TS-1, CDDP and PTX and the kinetics of them | — |
Countries
Japan
Contacts
Public ContactFurukawa Hiroshi
Sakai City Hospital Director
Outcome results
None listed