A Randomised Trial With Irinotecan, Cetuximab and Everolimus (ICE)Compared to Capecitabine and Oxaliplatin (CapOx) for Patients With Gemcitabin Resistant Pancreatic Cancer
NCT ID: NCT01042028
Last Updated: 2015-10-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1/PHASE2
39 participants
INTERVENTIONAL
2010-01-31
2014-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Phase II: Arm A
Regime A-ICE On progression or unacceptable toxicity patients can cross-over from regime A to regime B
Everolimus, Cetuximab, Irinotecan
Cetuximab 500 mg/m² iv biweekly Irinotecan 180 mg/m² iv biweekly Everolimus in daily MDT dosage
Arm B
Arm B: CapOx On progression or unacceptable toxicity patients can cross-over from regime B to regime A.
Capecitabine, Oxaliplatine
Capecitabine 1250 mg/m² bid. Oxaliplatin 70 mg/m² biweekly
Interventions
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Everolimus, Cetuximab, Irinotecan
Cetuximab 500 mg/m² iv biweekly Irinotecan 180 mg/m² iv biweekly Everolimus in daily MDT dosage
Capecitabine, Oxaliplatine
Capecitabine 1250 mg/m² bid. Oxaliplatin 70 mg/m² biweekly
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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?
18 Years
ALL
No
Sponsors
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Odense University Hospital
OTHER
Aarhus University Hospital
OTHER
Per Pfeiffer
OTHER
Responsible Party
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Per Pfeiffer
Professor
Principal Investigators
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Per Pfeiffer, MD
Role: PRINCIPAL_INVESTIGATOR
Odense University Hospital
Locations
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Department of Oncology, Aarhus Hospital
Aarhus, Aarhus, Denmark
Department of Oncology, Odense University Hospital
Odense, Odense, Denmark
Countries
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Other Identifiers
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ICE
Identifier Type: -
Identifier Source: org_study_id
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