The renal failure patients scheduled to intake TS-1
Conditions
Interventions
TS-1 is orally administered before breakfast and blood sample is obtained 7 times from day1 to day2. CLcr>
60
TS-1 is orally administered before breakfast and blood sample is obtained 7 times from day1 to day2. 59>
30
TS-1 is orally administered before breakfast and blood sample is obtained 7 times from day1 to day2. 29>
Sponsors
Keio University, School of Medicine, Div. of Gastroenterology, Dept.of Surgery.
St. Marianna University, School of Medicine Shinshu University, School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Stage 1 to 4 of renal function 2) Age over 20 at registration 3) dosing purpose does not matter 4) prior chemotherapy include TS-1 does not matter 5) The presence or absence of measurable lesion does not matter. 6) PS 0-2 7) oral intake 8) sufficient function of organs except renal function WBC: >=3,000/mm3 and <=12,000/mm3 Neu:>=1,500/mm3 Platelet: >=100,000/mm3 Hem: >=10.0g/dl AST(GOT): <= 100IU/l(or 150U/L if biliary drainage were present) ALT(GPT): <= 100IU/l(or 150U/L if biliary drainage were present) sT.bil: <=2.0mg/dl(or 3.0mg/dl if biliary drainage were present) 9) written informed consent
Exclusion criteria
Exclusion criteria: 1) pulmonary fibrosis and interstitial pneumonia 2) diarrhea 3) active infection 4) require blood transfusion within 14 days 5) severe complications 6) massive abdominal and pleural effusion 7) Being treated with flucytosine. 8) mental disease 9) Any patients judged by the investigator to be unfit to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To figure Area Under The Curve by measuring 5-FU blood level of the patients having renal failure. | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety within 24 hours after TS-1 intake | — |
Countries
Japan
Contacts
Public ContactEisuke Booka
Keio University, school of medecine Div. of Gastroenterology, Dept. of Surgery
Outcome results
None listed