drugset / Trial / NCT00506207
A Phase I Study of S-1 Plus Irinotecan and Oxaliplatin in Advanced Gastrointestinal Malignancy
NaSingle-groupOpen-labelTreatment
Summary
This study is an open-label, single center, and a dose-escalating phase I study to determine the maximal tolerated dose and the recommended dose of S-1 combined with irinotecan/oxaliplatin in patients with unresectable or metastatic colorectal or gastric carcinoma.
Timeline
- Start
- 2006-09
- Primary completion
- —
- Completion
- 2009-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Irinotecan | Small molecule | 120 mg/m2 | Intravenous |
| Subject | Irinotecan | Small molecule | 130 mg/m2 | Intravenous |
| Subject | Irinotecan | Small molecule | 140 mg/m2 | Intravenous |
| Subject | Irinotecan | Small molecule | 150 mg/m2 | Intravenous |
| Subject | Oxaliplatin | Small molecule | 85 mg/m2 | Intravenous |
| Subject | S-1 | Small molecule | 60 mg/m2 | Oral |
| Subject | S-1 | Small molecule | 70 mg/m2 | Oral |
| Subject | S-1 | Small molecule | 80 mg/m2 | Oral |