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

NCT01042028 | Terminated Phase 1 DMC

• 1 other identifier: ICE
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 2

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.

Conditions

Pancreatic Cancer

Keywords

Pancreas cancer; Everolimus; Irinotecan; Cetuximab; Capecitabine; Oxaliplatin; Gemcitabine resistant pancreascancer

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• 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

Study Arms (2)

Phase II: Arm A

EXPERIMENTAL

Regime A-ICE On progression or unacceptable toxicity patients can cross-over from regime A to regime B

Drug: Everolimus, Cetuximab, Irinotecan

Arm B

ACTIVE COMPARATOR

Arm B: CapOx On progression or unacceptable toxicity patients can cross-over from regime B to regime A.

Drug: Capecitabine, Oxaliplatine

Interventions

Everolimus, Cetuximab, Irinotecan DRUG

Cetuximab 500 mg/m² iv biweekly Irinotecan 180 mg/m² iv biweekly Everolimus in daily MDT dosage

Also known as: RAD001

Phase II: Arm A

Capecitabine, Oxaliplatine DRUG

Capecitabine 1250 mg/m² bid. Oxaliplatin 70 mg/m² biweekly

Also known as: Xeloda, Eloxatin

Arm B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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?

You may not qualify if:

• 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?

Sponsors & Collaborators

• Per Pfeiffer: lead
• Odense University Hospital: collaborator
• Aarhus University Hospital: collaborator

Study Sites (2)

Department of Oncology, Aarhus Hospital

Aarhus, Aarhus, 8000, Denmark

Location

Department of Oncology, Odense University Hospital

Odense, Odense, 5000, Denmark

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Everolimus; Cetuximab; Irinotecan; Capecitabine; Oxaliplatin

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Sirolimus; Macrolides; Lactones; Organic Chemicals; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Camptothecin; Alkaloids; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Coordination Complexes

Study Officials

• Per Pfeiffer, MD

  Odense University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 4, 2010
• First Posted: January 5, 2010
• Study Start: January 1, 2010
• Primary Completion: November 1, 2012
• Study Completion: January 1, 2014
• Last Updated: October 20, 2015

Record last verified: 2015-10

Locations

DK (2)