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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01042028
Other study ID # ICE
Secondary ID
Status Terminated
Phase Phase 1/Phase 2
First received January 4, 2010
Last updated October 18, 2015
Start date January 2010
Est. completion date January 2014

Study information

Verified date October 2015
Source Odense University Hospital
Contact n/a
Is FDA regulated No
Health authority Denmark: Danish Medicines Agency
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 39
Est. completion date January 2014
Est. primary completion date November 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
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

Locations

Country Name City State
Denmark Department of Oncology, Aarhus Hospital Aarhus
Denmark Department of Oncology, Odense University Hospital Odense

Sponsors (3)

Lead Sponsor Collaborator
Per Pfeiffer Aarhus University Hospital, Odense University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Phase I: Establish maximum tolerable (MTD) dose of ICE (Irinotecan, Cetuximab and Everolimus) 4 months Yes
Primary Phase I: Determine the maximum tolerated dose (MTD) of ICE in patients with gemcitabine resistant pancreatic cancer 4 months Yes
Primary Phase II: Progression-free survival as measured from inclusion to either documentation of disease progression or death 18 months No
Secondary 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 No
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