drugset / Trial / NCT02368860
OXIRI [Oxaliplatin (O), Xeloda (X) and Irinotecan (I)] in Pancreatic Adenocarcinoma
Phase 1
Completed
33 enrolled
National Cancer Centre, Singapore
National Medical Research Council (NMRC), Singapore · collab
NaSingle-groupOpen-labelTreatment
Summary
This is an exploratory Phase I study is to assess the safety and tolerability of the OXIRI regimen \[oxaliplatin (O), xeloda (X) and irinotecan (I)\] and to evaluate for preliminary evidence of efficacy, in patients with advanced and/or metastatic pancreatic adenocarcinoma. The investigators hypothesize that 2 of 3 weekly doses of oxaliplatin and genotype directed-dosing of irinotecan in combination with chronomodulated capecitabine (xeloda) administered continuously will be more tolerable than the FOLFIRINOX regimen (folinic acid, fluorouracil, irinotecan and oxaliplatin) while maintaining anti-tumour activity.
Timeline
- Start
- 2013-09-17
- Primary completion
- 2020-05-21
- Completion
- 2020-05-21
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Capecitabine | Small molecule | — | — |
| Subject | Irinotecan | Small molecule | — | Intravenous |
| Subject | Oxaliplatin | Small molecule | 50 mg/m2 | Intravenous |