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

Per Pfeiffer

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Pancreatic Cancer

Treatments: Drug: Capecitabine, Oxaliplatine; Drug: Everolimus, Cetuximab, Irinotecan

Study type: Interventional

Funder types: Other

Identifiers

NCT01042028

ICE

Details and patient eligibility

About

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.

Enrollment: 39 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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?

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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39 participants in 2 patient groups

Phase II: Arm A

Experimental group

Description:

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

Treatment:

Drug: Everolimus, Cetuximab, Irinotecan

Arm B

Active Comparator group

Description:

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

Treatment:

Drug: Capecitabine, Oxaliplatine