Pancreatic Cancer
Conditions
Keywords
Pancreas cancer, Everolimus, Irinotecan, Cetuximab, Capecitabine, Oxaliplatin, Gemcitabine resistant pancreascancer
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.
Interventions
DRUGEverolimus, Cetuximab, Irinotecan
Cetuximab 500 mg/m² iv biweekly Irinotecan 180 mg/m² iv biweekly Everolimus in daily MDT dosage
DRUGCapecitabine, Oxaliplatine
Capecitabine 1250 mg/m² bid. Oxaliplatin 70 mg/m² biweekly
Sponsors
Odense University Hospital
Aarhus University Hospital
Per Pfeiffer
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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?
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase I: Establish maximum tolerable (MTD) dose of ICE (Irinotecan, Cetuximab and Everolimus) | 4 months |
| Phase I: Determine the maximum tolerated dose (MTD) of ICE in patients with gemcitabine resistant pancreatic cancer | 4 months |
| Phase II: Progression-free survival as measured from inclusion to either documentation of disease progression or death | 18 months |
Secondary
| Measure | Time frame |
|---|---|
| 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 | 22 months |
Countries
Denmark
Outcome results
None listed