Patients with cancer scheduled to have S-1 monotherapy
Conditions
Interventions
S-1 is orally administered before breakfast and blood sample is obtained 6 times from day1 to day2. S-1 is administered for 4 weeks and rest for 2 weeks. CLcr>
60
S-1 is orally administered before breakfast and blood sample is obtained 6 times from day1 to day2. S-1 is administered for 4 weeks and rest for 2 weeks. 59>
30
S-1 is orally administered before breakfast and blood sample is obtained 6 times from day1 to day2. S-1 is administered for 4 weeks and rest for 2 weeks. 29>
Sponsors
Keio University School of medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Scheduled to S-1 monotherapy 2) CLcr>15mL/min 3) Age over 20 at registration 4) prior chemotherapy include S-1 does not matter 5) The presence or absence of measurable lesion does not matter. 6) PS 0, 1 7) oral intake 8) sufficient function of organs except renal function WBC: >=3,500/mm3 and <=12,000/mm3 Neu:>=2,000/mm3 Platelet: >=100,000/mm3 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: <=1.5mg/dl 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) dialysis 7) massive abdominal and pleural effusion 8) Being treated with flucytosine. 9) mental disease 10) hypersensitive to 5-FU 11) Any patients judged by the investigator to be unfit to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To confirm AUC of 5-FU was valid when S-1 calculated by B-B formula was administered | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate safety when S-1 calculated by B-B formula was administered | — |
Countries
Japan
Contacts
Public ContactHirofumi Kawakubo
Keio University School of medicine Department of Surgery
Outcome results
None listed