drugset / Trial / NCT01136031
Paclitaxel and Irinotecan in Advanced Gastric Cancer
Non-randomizedSingle-groupOpen-labelTreatment
Summary
* Usually the combination of fluoropyrimidine with platinum is used as a first line chemotherapy (for example, 5-FU+cisplatin, capecitabine+cisplatin, S-1+ cisplatin, 5-FU+oxaliplatin) in advanced gastric cancer. * After failure with this combination, taxane-based regimen or irinotecan-based regimen is usually used. But, as a second-line regimen, the combination of topoisomerase inhibitor with taxane has not been fully evaluated until now. * So we designed this phase I/II study to evaluate the efficacy and toxicity of second-line chemotherapy with paclitaxel and irinotecan in fluoropyrimidine and platinum-pretreated advanced gastric cancer.
Timeline
- Start
- 2008-01
- Primary completion
- 2011-06
- Completion
- 2011-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Irinotecan | Small molecule | 100 mg/m2 | — |
| Subject | Irinotecan | Small molecule | 120 mg/m2 | — |
| Subject | Irinotecan | Small molecule | 160 mg/m2 | — |
| Subject | Paclitaxel | Small molecule | 100 mg/m2 | — |
| Subject | Paclitaxel | Small molecule | 135 mg/m2 | — |