patients with metatastatic pancreatic cancer
Conditions
Interventions
Product Name: certican
Product Code: SE/H/356/03
Pharmaceutical Form: Tablet
Product Name: capecitabine
Product Code: EMEA/H/C/316
Pharmaceutical Form: Tablet
Product Name: cetuximab
Product Code: E
Sponsors
None listed
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -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 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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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) - Response duration - Toxicity profile - 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. 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. | — |
Countries
Netherlands
Outcome results
None listed