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A Randomised Trial With Irinotecan, Cetuximab and Everolimus (ICE)Compared to Capecitabine and Oxaliplatin (CapOx) for Patients With Gemcitabin Resistant Pancreatic Cancer

NCT01042028 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2015-10-20

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Odense University Hospital

    collaborator OTHER

  • Aarhus University Hospital

    collaborator OTHER

  • Per Pfeiffer

    lead OTHER

Principal Investigators

  • Per Pfeiffer, MD · Odense University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2012-11-30
Completion
2014-01-31

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01042028 on ClinicalTrials.gov