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 - CEC
- Conditions
- patients with metatastatic pancreatic cancer
- Registration Number
- EUCTR2008-007686-24-NL
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 35
-Signed informed content obtained prior to treatment
-Cytological or histological confirmed adenocarcinoma of the pancreas
-Metastatic pancreatic cancer
-Measurable lesion according to RECIST criteria (see Appendix)
-ECOG/ WHO performance 0-2 (see Appendix)
-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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
-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 clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: In this study we want to determine the activity and safety of concurrent interruption of the MAPK and PI3K pathways by EGFR and mTOR inhibition in patients with metatastatic pancreatic cancer ;Secondary Objective: -Time to progression (TTP)<br>-Response duration<br>-Toxicity profile<br>-Pharmacodynamics;Primary end point(s): For the phase I part: Assessment of the dose limiting toxicity (DLT) and the maximal tolerated dose (MTD) of the combination of everolimus, cetuximab and capecitabine.<br>For the phase II part: Determination of the efficacy and feasibility of the combination of everolimus, cetuximab and capecitabine. Primary endpoint of the study will be response rate.<br>
- Secondary Outcome Measures
Name Time Method