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

P

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

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)

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

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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