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
Recruitment status was Not yet recruiting
Sponsor:
Odense University Hospital
Information provided by:
Odense University Hospital
ClinicalTrials.gov Identifier:
NCT01042028
First received: January 4, 2010
Last updated: January 5, 2010
Last verified: December 2009
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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:
Drug Information available for:
Sirolimus
Oxaliplatin
Irinotecan
Irinotecan hydrochloride
Capecitabine
Everolimus
Temsirolimus
Cetuximab
U.S. FDA Resources
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:
- 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?
Contacts and Locations
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 Antibiotics, Antineoplastic Antifungal Agents Anti-Infective Agents Anti-Bacterial Agents Antineoplastic Agents, Phytogenic Radiation-Sensitizing Agents Topoisomerase I Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors |
ClinicalTrials.gov processed this record on May 19, 2013