Pharmacokinetics of S-1 in cancer patients with renal dysfunction.
- Conditions
- Solid tumors
- Registration Number
- JPRN-UMIN000003959
- Lead Sponsor
- Medical Oncology/Hematology, Kobe University Hospital and Graduate School of Medicine
- Brief Summary
A total of 33 patients were enrolled and classified into 4 groups. Those in cohorts 3 and 4 treated with an adjusted dose of S1 showed a similar area under the curve for 5fluorouracil compared with cohort 2. Notably, while there was a statistically significant difference between cohort 1 and 2 (P = 0.0474) treated with an equal dose of S1, there was no significant difference observed in the toxicity profiles of the cohorts.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 33
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pharmacokinetics of FT, 5FU and CDHP on day 8 of TS-1 administration.
- Secondary Outcome Measures
Name Time Method