Clinical trial · Interventional
A Randomised Trial With Irinotecan, Cetuximab and Everolimus (ICE)Compared to Capecitabine and Oxaliplatin (CapOx) for Patients With Gemcitabin Resistant Pancreatic Cancer
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Emergence of FOLFIRINOX and slow recruitment
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Capecitabine, Oxaliplatine | Drug | — | UNRESOLVED |
| Everolimus, Cetuximab, Irinotecan | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Phase II: Arm A
- description
- Regime A-ICE On progression or unacceptable toxicity patients can cross-over from regime A to regime B
- interventionNames
- Drug: Everolimus, Cetuximab, Irinotecan
- type
- ACTIVE_COMPARATOR
- label
- Arm B
- description
- Arm B: CapOx On progression or unacceptable toxicity patients can cross-over from regime B to regime A.
- interventionNames
- Drug: Capecitabine, Oxaliplatine
Primary outcomes (3)
- measure
- Phase I: Establish maximum tolerable (MTD) dose of ICE (Irinotecan, Cetuximab and Everolimus)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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?
References
Publications (0)
Data not yet available