Clinical trialPhase 1 / Phase 2Terminated
A Randomised Trial With Irinotecan, Cetuximab and Everolimus (ICE)Compared to Capecitabine and Oxaliplatin (CapOx) for Patients With Gemcitabin Resistant Pancreatic Cancer
A Randomised Fase I/II Trial With Irinotecan, Cetuximab and Everolimus (ICE)Compared to Capecitabine and Oxaliplatin (CapOx) for Patients With Gemcitabin Resistant Pancreatic Cancer
- Outcome
- Stopped earlyEmergence of FOLFIRINOX and slow recruitment (Enrollment)
- Phase
- Phase 1 / Phase 2
- Status
- Terminated
- Study type
- Interventional
- Start
- January 2010
- Expected end
- January 2014
- Enrollment
- 39 participants
- Sites
- 2
- Primary outcomes
- Phase I: Establish maximum tolerable (MTD) dose of ICE (Irinotecan, Cetuximab and Everolimus); Phase I: Determine the maximum tolerated dose (MTD) of ICE in patients with gemcitabine resistant pancreatic cancer; Phase II: Progression-free survival as measured from inclusion to either documentation of disease progression or death
- Sponsor
- Other
- Results posted
- No
- Last update
- 20 October 2015
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Brief summary public domain (ClinicalTrials.gov)
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.