Trials / Terminated
TerminatedNCT01042028
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
- Status
- Terminated
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 39 (actual)
- Sponsor
- Per Pfeiffer · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Everolimus, Cetuximab, Irinotecan | Cetuximab 500 mg/m² iv biweekly Irinotecan 180 mg/m² iv biweekly Everolimus in daily MDT dosage |
| DRUG | Capecitabine, Oxaliplatine | Capecitabine 1250 mg/m² bid. Oxaliplatin 70 mg/m² biweekly |
Timeline
- Start date
- 2010-01-01
- Primary completion
- 2012-11-01
- Completion
- 2014-01-01
- First posted
- 2010-01-05
- Last updated
- 2015-10-20
Locations
2 sites across 1 country: Denmark
Source: ClinicalTrials.gov record NCT01042028. Inclusion in this directory is not an endorsement.