A phase I/ II, non-randomized, feasibility/ safety and efficacy study of the combination of everolimus, cetuximab and capecitabine in patients with metastatic pancreatic cancer

Phase 2

Conditions: 10017991
metastatic pancreatic cancer

Registration Number: NL-OMON32581

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 35

Inclusion Criteria

*Cytological or histological confirmed adenocarcinoma of the pancreas
*Metastatic pancreatic cancer
*ECOG/ WHO performance 0-2
*Age > 18 years
*Life expectancy > 3 months
*Adequate renal function (creatinine < 150 µmol/L)
*Adequate liver function (bilirubin < 2.5 times upper limit of normal, ALAT or ASAT < 5.0 times upper limit of normal in case of liver metastases and < 2.5 the upper limit of normal in absence of liver metastases
*Adequate bone marrow function (WBC > 3.0 x 10 9/L, platelets > 100 x 10 9/L)
*Mentally, physically, and geographically able to undergo treatment and follow up

Exclusion Criteria

*Clinical or radiological evidence of CNS metastases
*Pregnancy (positive serum pregnancy test) or patients (male/female with reproductive potential (without effective contraception) or lactation
*Concomitent treatment with other experimental drugs or any other anticancer therapy
*Previous treatment with cetuximab
*Other malignancy within the last 5 years, except adequately treated basocellular skin carcinoma or cervical carcinoma
*Medical or physiological conditions that would not permit the subject to complete the study or sign informed consent
*Serious concomitant systemic disorder that would compromise the safety of the patient, at the discretion of the investigator

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>For the phase I part: Assessment of the dose limiting toxicity (DLT) and the<br /><br>maximal tolerated dose (MTD) of the combination of everolimus, cetuximab and<br /><br>capecitabine.<br /><br>For the phase II part: Determination of the efficacy and feasibility of the<br /><br>combination of everolimus, cetuximab and capecitabine. Primary endpoint of the<br /><br>study will be response rate. </p><br>

Secondary Outcome Measures