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

Pancreatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01042028
• Other study ID #: ICE
• 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

• Pancreatic Cancer
• Pancreatic Neoplasms

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