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

Phase 1

Terminated

• Conditions: Pancreatic Cancer
• Interventions: Drug: Everolimus, Cetuximab, Irinotecan; Drug: Capecitabine, Oxaliplatine

• Registration Number: NCT01042028
• Lead Sponsor: Per Pfeiffer

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-01-04
• Study First Submitted QC: 2010-01-04
• Study First Posted: 2010-01-05
• Primary Completion: 2012-11
• Study Completion: 2014-01
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-18
• Last Update Posted: 2015-10-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 39

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?

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Phase II: Arm A	Everolimus, Cetuximab, Irinotecan	Regime A-ICE On progression or unacceptable toxicity patients can cross-over from regime A to regime B
Arm B	Capecitabine, Oxaliplatine	Arm B: CapOx On progression or unacceptable toxicity patients can cross-over from regime B to regime A.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Department of Oncology, Aarhus Hospital; 🇩🇰 Aarhus, Denmark

Department of Oncology, Odense University Hospital; 🇩🇰 Odense, Denmark