A Randomised Trial With Irinotecan, Cetuximab And Everolimus (ICE)Compared To Capecitabine And Oxaliplatin (CapOx) For Patients With Gemcitabin Resistant Pancreatic Cancer

Study Overview

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

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.

N/A

Pancreatic Cancer

DRUG: Everolimus, Cetuximab, Irinotecan
DRUG: Capecitabine, Oxaliplatine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2010-01-04	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2015-10-18
First Submitted that Met QC Criteria 2010-01-04	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2015-10-20
First Posted (ESTIMATED) 2010-01-05	Results First Posted N/A	Last Verified 2015-10

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Crossover

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Phase II: Arm A Regime A-ICE On progression or unacceptable toxicity patients can cross-over from regime A to regime B	DRUG: Everolimus, Cetuximab, Irinotecan Cetuximab 500 mg/m² iv biweekly Irinotecan 180 mg/m² iv biweekly Everolimus in daily MDT dosage
ACTIVE_COMPARATOR: Arm B Arm B: CapOx On progression or unacceptable toxicity patients can cross-over from regime B to regime A.	DRUG: Capecitabine, Oxaliplatine Capecitabine 1250 mg/m² bid. Oxaliplatin 70 mg/m² biweekly

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Phase II: Arm A

Regime A-ICE On progression or unacceptable toxicity patients can cross-over from regime A to regime B

DRUG: Everolimus, Cetuximab, Irinotecan

Cetuximab 500 mg/m² iv biweekly Irinotecan 180 mg/m² iv biweekly Everolimus in daily MDT dosage

ACTIVE_COMPARATOR: Arm B

Arm B: CapOx On progression or unacceptable toxicity patients can cross-over from regime B to regime A.

DRUG: Capecitabine, Oxaliplatine

Capecitabine 1250 mg/m² bid. Oxaliplatin 70 mg/m² biweekly

Primary Outcome Measures	Measure Description	Time Frame
Phase I: Establish maximum tolerable (MTD) dose of ICE (Irinotecan, Cetuximab and Everolimus)		4 months
Phase I: Determine the maximum tolerated dose (MTD) of ICE in patients with gemcitabine resistant pancreatic cancer		4 months
Phase II: Progression-free survival as measured from inclusion to either documentation of disease progression or death		18 months

Secondary Outcome Measures	Measure Description	Time Frame
Survival All events grade 1-5 according to NCI-CTCAE in fase I All Adverse events grade 1-5 according to NCI-CTCAEW in Fase II Correlation between effect of treatment and tumourmarkers Quality of life - EORTC QLQ Time to failure of Strategy		22 months

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Odense University Hospital
Aarhus University Hospital

Investigators

PRINCIPAL_INVESTIGATOR: Per Pfeiffer, MD, Odense University Hospital

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Clinical Trial Record