ClinicalTrials.gg
Sign In
TerminatedNCT01042028Updated Oct 20, 2015

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

A Phase 1/2 interventional study of Everolimus, Cetuximab, Irinotecan and Capecitabine, Oxaliplatine in Pancreatic Cancer, sponsored by Per Pfeiffer. Terminated at 2 sites in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-10-20.

Sponsored by Per Pfeiffer · Phase 1/2, Interventional, and Treatment

Why this study was terminated
Emergence of FOLFIRINOX and slow recruitment
Phase
Phase 1/2
Study type
Interventional
Enrollment
39
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

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.

02

Conditions studied

  • Pancreatic Cancer

Keywords

  • Pancreas cancer
  • Everolimus
  • Irinotecan
  • Cetuximab
  • Capecitabine
  • Oxaliplatin
  • Gemcitabine resistant pancreascancer
03

In context

Pancreatic Neoplasms

3,310 studies on the registry are indexed under Pancreatic Neoplasms; 910 are open to participants now.

This study's enrollment of 39 is below the median of 46 across 2,480 interventional studies indexed under Pancreatic Neoplasms.

Browse Pancreatic Neoplasms studies →

Lead sponsor

Per Pfeiffer is the lead sponsor of 8 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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?
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
39 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • DrugEverolimus, Cetuximab, Irinotecan

    Drug pages: Everolimus · Cetuximab · Irinotecan

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

    Also known as: RAD001

  • DrugCapecitabine, Oxaliplatine

    Drug pages: Capecitabine · Oxaliplatin

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

    Also known as: Xeloda, Eloxatin

06

What researchers measure

Primary outcomes

  1. Phase I: Establish maximum tolerable (MTD) dose of ICE (Irinotecan, Cetuximab and Everolimus)

    Time frame: 4 months

  2. Phase I: Determine the maximum tolerated dose (MTD) of ICE in patients with gemcitabine resistant pancreatic cancer

    Time frame: 4 months

  3. Phase II: Progression-free survival as measured from inclusion to either documentation of disease progression or death

    Time frame: 18 months

Secondary outcomes

  1. 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

07

Study locations

2 sites
  • Department of Oncology, Aarhus Hospital
    Aarhus, Aarhus 8000, Denmark
  • Department of Oncology, Odense University Hospital
    Odense, Odense 5000, Denmark
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 20, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01042028
Lead sponsor
Per Pfeiffer
Collaborators
Odense University Hospital, Aarhus University Hospital
Responsible party
Per Pfeiffer (Professor, Odense University Hospital) — Sponsor-investigator
First posted
Jan 5, 2010
Start date
Jan 2010
Primary completion
Nov 2012
Completion
Jan 2014
Last update
Oct 20, 2015

Study contacts

Per Pfeiffer, MD
principal investigator · Odense University Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Oct 2015. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drugs tested here: Everolimus · Cetuximab · Irinotecan

Other studies in this condition

Pancreatic Neoplasms →

Other studies from this sponsor

Per Pfeiffer

Start the discussion