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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

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ClinicalTrials.gov Identifier: NCT01042028
Recruitment Status : Terminated (Emergence of FOLFIRINOX and slow recruitment)
First Posted : January 5, 2010
Last Update Posted : October 20, 2015
Odense University Hospital
Aarhus University Hospital
Information provided by (Responsible Party):
Per Pfeiffer, Odense University Hospital

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.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Drug: Everolimus, Cetuximab, Irinotecan Drug: Capecitabine, Oxaliplatine Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : January 2010
Primary Completion Date : November 2012
Study Completion Date : January 2014

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
Other Name: RAD001
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
Other Name: Xeloda, Eloxatin

Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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?

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01042028

Department of Oncology, Aarhus Hospital
Aarhus, Denmark, 8000
Department of Oncology, Odense University Hospital
Odense, Denmark, 5000
Sponsors and Collaborators
Per Pfeiffer
Odense University Hospital
Aarhus University Hospital
Principal Investigator: Per Pfeiffer, MD Odense University Hospital, Odense, Denmark

Responsible Party: Per Pfeiffer, Professor, Odense University Hospital
ClinicalTrials.gov Identifier: NCT01042028     History of Changes
Other Study ID Numbers: ICE
First Posted: January 5, 2010    Key Record Dates
Last Update Posted: October 20, 2015
Last Verified: October 2015

Keywords provided by Per Pfeiffer, Odense University Hospital:
Pancreas cancer
Gemcitabine resistant pancreascancer

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic