drugset / Trial / NCT00632268
Low-dose RAD001(Everolimus) Plus Cisplatin-HDFL Chemotherapy for the First-line Treatment of Advanced Gastric Cancer
Phase 2
Completed
40 enrolled
National Taiwan University Hospital
National Cheng-Kung University Hospital · collabTaipei Veterans General Hospital, Taiwan · collab
NaSingle-groupOpen-labelTreatment
Summary
The primary end-point of this study is to evaluate the objective response rates, and the secondary end-points are overall survival, progression-free survival and safety profile of low-dose RAD001 (everolimus) plus cisplatin and HDFL (weekly 24-hour infusion of high-dose 5-FU and leucovorin) chemotherapy in the first-line treatment for patients with unresectable, recurrent, or metastatic gastric cancer.
Timeline
- Start
- 2008-02
- Primary completion
- 2012-09
- Completion
- 2012-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Everolimus | Small molecule | 10 mg | Oral |
| Background | Cisplatin | Other / unclassified | 35 mg/m2 | Intravenous |
| Background | Leucovorin | Small molecule | 300 mg/m2 | Intravenous |
| Background | fluorouracil | Small molecule | 2000 mg/m2 | Intravenous |