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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2009 by Odense University Hospital.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Odense University Hospital
ClinicalTrials.gov Identifier:
NCT01042028
First received: January 4, 2010
Last updated: January 5, 2010
Last verified: December 2009
  Purpose

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 Intervention Phase
Pancreatic Cancer
Drug: Everolimus, Cetuximab, Irinotecan
Drug: Capecitabine, Oxaliplatine
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Odense University Hospital:

Primary Outcome Measures:
  • Phase I: Establish maximum tolerable (MTD) dose of ICE (Irinotecan, Cetuximab and Everolimus) [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
  • Phase I: Determine the maximum tolerated dose (MTD) of ICE in patients with gemcitabine resistant pancreatic cancer [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
  • Phase II: Progression-free survival as measured from inclusion to either documentation of disease progression or death [ Time Frame: 18 months ] [ Designated as safety issue: No ]

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 [ Time Frame: 22 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: January 2010
Estimated Study Completion Date: November 2011
Estimated Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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?
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01042028

Contacts
Contact: Per Pfeiffer, MD +45 6541 1590 per.pfeiffer@ouh.regionsyddanmark.dk
Contact: Christina Nordenbæk +45 6541 2060 christina.nordenbaek@ouh.regionsyddanmark.dk

Locations
Denmark
Department of oncology, Aalborg University Hospital Not yet recruiting
Aalborg, Denmark
Contact: Mette Yilmaz, MD    +45 9932 1111    my@dadlnet.dk   
Principal Investigator: Mette Yilmaz, MD         
Department of Oncology, Aarhus Hospital Not yet recruiting
Aarhus, Denmark, 8000
Contact: Morten Ladekarl, MD       mlade@as.aaa.dk   
Principal Investigator: Morten Ladekarl, MD         
Department of Oncololy, Herlev University Hospital Not yet recruiting
Herlev, Denmark
Contact: Benny Vittrup Jensen, MD    +45 4488 4488    BEVI@heh.regionh.dk   
Principal Investigator: Benny Vittrup Jensen, MD         
Department of Oncology, Odense University Hospital Not yet recruiting
Odense, Denmark, 5000
Contact: Per Pfeiffer, MD    +45 6541 1590    per.pfeiffer@ouh.regionsyddanmark.dk   
Sponsors and Collaborators
Odense University Hospital
Investigators
Principal Investigator: Per Pfeiffer, MD Odense University Hospital, Odense, Denmark
  More Information

No publications provided

Responsible Party: Per Pfeiffer, MD, Department of Oncology, Odense University Hospital
ClinicalTrials.gov Identifier: NCT01042028     History of Changes
Other Study ID Numbers: ICE
Study First Received: January 4, 2010
Last Updated: January 5, 2010
Health Authority: Denmark: Danish Medicines Agency

Keywords provided by Odense University Hospital:
Pancreas cancer
Everolimus
Irinotecan
Cetuximab
Capecitabine
Oxaliplatin
Gemcitabine resistant pancreascancer

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Oxaliplatin
Irinotecan
Capecitabine
Cetuximab
Sirolimus
Fluorouracil
Everolimus
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents
Antineoplastic Agents, Phytogenic
Radiation-Sensitizing Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on August 19, 2014