Solid tumors
Conditions
Interventions
eGFR is more than 80 ml/min/1.73m2
eGFR is 50 ml/min/1.73m2 to 80 ml/min/1.73m2
eGFR is 30 ml/min/1.73m2 to 50 ml/min/1.73m2
eGFR is less than 30 ml/min/1.73m2
Sponsors
Medical Oncology/Hematology, Kobe University Hospital and Graduate School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with malignant solid tumors or hematological malignancy. 2. Patients receiving TS-1 therapy as clinical practice. 3. age > 20 years. 4. Adequate hepatic and renal function. 5. Written informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients in hemodialysis. 2. Patients who had received TS-1 < 2 weeks prior to starting study drug. 3. Patients who had received cisplatin < 3 months prior to starting study drug. 4. Patients who had received any other chemotherapy < 3 weeks prior to starting study drug. 5. Patients who had undergone major surgery < 2 weeks prior to starting study drug. 6. Patients with malabsorption. 7. Patients with pleural effusion or ascitis requireing drainage. 8. Severe and/or uncontroled infection 9. Other concurrent severe and/or uncontroled concomitant medical conditions. 10. Patients who are currently receiving treatment with flucytosine, phenitoin or warfarin. 11. Patients judged inappropriate for the study by the physicians
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetics of FT, 5FU and CDHP on day 8 of TS-1 administration. | — |
Countries
Japan
Contacts
Public ContactYutaka Fujiwara
Kobe University Hospital and Graduate School of Medicine Medical Oncology/Hematology
Outcome results
None listed