drugset / Trial / NCT01042028
A Randomised Trial With Irinotecan, Cetuximab and Everolimus (ICE)Compared to Capecitabine and Oxaliplatin (CapOx) for Patients With Gemcitabin Resistant Pancreatic Cancer
Phase 1/2
Terminated
39 enrolled
Per Pfeiffer
Aarhus University Hospital · collabOdense University Hospital · collab
RandomizedCrossoverOpen-labelTreatment
Summary
This is an open multicenter randomized phase I/II study. The main purpose with this study is to investigate dose and efficacy of a combination of Irinotecan, Cetuximab and Everolimus given biweekly to patients with local advanced or metastatic pancreatic cancer AFTER progression from 1. line treatment with Gemcitabine.
Timeline
- Start
- 2010-01
- Primary completion
- 2012-11
- Completion
- 2014-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Capecitabine | Small molecule | 1250 mg/m2 | — |
| Subject | Cetuximab | Monoclonal antibody | 500 mg/m2 | Intravenous |
| Subject | Everolimus | Small molecule | — | — |
| Subject | Irinotecan | Small molecule | 180 mg/m2 | Intravenous |
| Comparator | Oxaliplatin | Small molecule | 70 mg/m2 | — |