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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

Primary Purpose

Pancreatic Cancer

Status
Terminated
Phase
Phase 1
Locations
Denmark
Study Type
Interventional
Intervention
Everolimus, Cetuximab, Irinotecan
Capecitabine, Oxaliplatine
Sponsored by
Per Pfeiffer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Cancer focused on measuring Pancreas cancer, Everolimus, Irinotecan, Cetuximab, Capecitabine, Oxaliplatin, Gemcitabine resistant pancreascancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Written informed consent obtained prior to study entry?
  2. Patient has histologically/cytologically proven, non-resectable or metastatic, adenocarcinoma of the pancreas?
  3. Progressive disease during adjuvant chemotherapy (or within 6 month after) or progressive disease during or after first line chemotherapy?
  4. Former treatment with chemotherapeutic agent containing gemcitabine?
  5. Is the age of the patient ≥ 18 years?
  6. Is the ECOG performance status 0-1?
  7. Is the absolute neutrophil count (ANC) ≥ 1.5 x 109/l?
  8. Is the platelet count ≥ 75 x 109/l?
  9. Is the total bilirubin ≤1.5 x UNL (upper normal limit)?
  10. Patient has normal liver function? (If liver metastases are present, there is no upper limit for ALAT/SPGT/alk phosph)?
  11. Creatinine clearance ≥ 30 ml/min
  12. Is the patient capable of following the treatment and the plan of evaluation?

Exclusion Criteria:

  1. CTC Grade 3 hyperlipidaemia (>10.34 mmol/l) in spite of treatment
  2. Active former or concurrent history of malignant neoplasm, in the last 2 years?
  3. Any condition or therapy which, by the investigators opinion, will expose the patient to a risk or will affect the purpose of the clinical trial?
  4. Pregnant or breast feeding patient (fertile patients must use contraceptives)?
  5. Infections or other serious medical conditions, which can obstruct the patient's possibility of receiving the treatment? (for instance serious heart, metabolic or lung disease)
  6. Known hypersensitivity toward one or more of the parts in the treatment?

Sites / Locations

  • Department of Oncology, Aarhus Hospital
  • Department of Oncology, Odense University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Phase II: Arm A

Arm B

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
January 4, 2010
Last Updated
October 18, 2015
Sponsor
Per Pfeiffer
Collaborators
Odense University Hospital, Aarhus University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01042028
Brief Title
A Randomised Trial With Irinotecan, Cetuximab and Everolimus (ICE)Compared to Capecitabine and Oxaliplatin (CapOx) for Patients With Gemcitabin Resistant Pancreatic Cancer
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Terminated
Why Stopped
Emergence of FOLFIRINOX and slow recruitment
Study Start Date
January 2010 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
January 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Per Pfeiffer
Collaborators
Odense University Hospital, Aarhus University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
Keywords
Pancreas cancer, Everolimus, Irinotecan, Cetuximab, Capecitabine, Oxaliplatin, Gemcitabine resistant pancreascancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Phase II: Arm A
Arm Type
Experimental
Arm Description
Regime A-ICE On progression or unacceptable toxicity patients can cross-over from regime A to regime B
Arm Title
Arm B
Arm Type
Active Comparator
Arm Description
Arm B: CapOx On progression or unacceptable toxicity patients can cross-over from regime B to regime A.
Intervention Type
Drug
Intervention Name(s)
Everolimus, Cetuximab, Irinotecan
Other Intervention Name(s)
RAD001
Intervention Description
Cetuximab 500 mg/m² iv biweekly Irinotecan 180 mg/m² iv biweekly Everolimus in daily MDT dosage
Intervention Type
Drug
Intervention Name(s)
Capecitabine, Oxaliplatine
Other Intervention Name(s)
Xeloda, Eloxatin
Intervention Description
Capecitabine 1250 mg/m² bid. Oxaliplatin 70 mg/m² biweekly
Primary Outcome Measure Information:
Title
Phase I: Establish maximum tolerable (MTD) dose of ICE (Irinotecan, Cetuximab and Everolimus)
Time Frame
4 months
Title
Phase I: Determine the maximum tolerated dose (MTD) of ICE in patients with gemcitabine resistant pancreatic cancer
Time Frame
4 months
Title
Phase II: Progression-free survival as measured from inclusion to either documentation of disease progression or death
Time Frame
18 months
Secondary Outcome Measure Information:
Title
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
Time Frame
22 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Written informed consent obtained prior to study entry? Patient has histologically/cytologically proven, non-resectable or metastatic, adenocarcinoma of the pancreas? Progressive disease during adjuvant chemotherapy (or within 6 month after) or progressive disease during or after first line chemotherapy? Former treatment with chemotherapeutic agent containing gemcitabine? Is the age of the patient ≥ 18 years? Is the ECOG performance status 0-1? Is the absolute neutrophil count (ANC) ≥ 1.5 x 109/l? Is the platelet count ≥ 75 x 109/l? Is the total bilirubin ≤1.5 x UNL (upper normal limit)? Patient has normal liver function? (If liver metastases are present, there is no upper limit for ALAT/SPGT/alk phosph)? Creatinine clearance ≥ 30 ml/min Is the patient capable of following the treatment and the plan of evaluation? Exclusion Criteria: CTC Grade 3 hyperlipidaemia (>10.34 mmol/l) in spite of treatment Active former or concurrent history of malignant neoplasm, in the last 2 years? Any condition or therapy which, by the investigators opinion, will expose the patient to a risk or will affect the purpose of the clinical trial? Pregnant or breast feeding patient (fertile patients must use contraceptives)? Infections or other serious medical conditions, which can obstruct the patient's possibility of receiving the treatment? (for instance serious heart, metabolic or lung disease) Known hypersensitivity toward one or more of the parts in the treatment?
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Per Pfeiffer, MD
Organizational Affiliation
Odense University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Oncology, Aarhus Hospital
City
Aarhus
ZIP/Postal Code
8000
Country
Denmark
Facility Name
Department of Oncology, Odense University Hospital
City
Odense
ZIP/Postal Code
5000
Country
Denmark

12. IPD Sharing Statement

Learn more about this trial

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

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