drugset / Trial / NCT00209612
Phase I/II Study of Paclitaxel Plus CPT-11 in Pts. With 2nd Line Chemotherapy of Inoperable or Recurrent GC.
Phase 1/2
Withdrawn
40 enrolled
Hokkaido Gastrointestinal Cancer Study Group
Hokkaido University Hospital · collab
Non-randomizedSingle-groupOpen-labelTreatment
Summary
A phase I/II study is conducted to determine the maximum-tolerated dose (MTD), dose-limiting toxicity (DLT), and efficacy of a combination chemotherapy using CPT-11 and Paclitaxel in pre-treated patients with metastatic gastric cancer. The usefulness of the this regimen is evaluated by response rate, median survival time, and progression free survival.
Timeline
- Start
- 2004-04
- Primary completion
- 2008-11
- Completion
- 2009-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Irinotecan | Small molecule | 80 mg/m2 | Intravenous |
| Subject | Paclitaxel | Small molecule | 60 mg/m2 | Intravenous |