locally advanced and metastatic pancreatic cancer MedDRA version: llt Level: LLT Classification code 10033604 Term:
Conditions
Interventions
Product Name: erlotinib
Product Code: CHMP/511166/2006
Pharmaceutical Form: Tablet
Product Name: gemcitabine
Product Code: CHMP/512295/08
Pharmaceutical Form: Intravenous infusion
Product Name: metf
Sponsors
Academic Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Cytological or histological confirmed carcinoma of the pancreas -Measurable lesion according to RECIST criteria -ECOG/ WHO performance 0-2 -Age > 18 years -Life expectancy > 3 months -Adequate renal function (creatinine 60 ml/ L) -Adequate liver function (bilirubin 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) and lactation -Serious concomitant systemic disorder that would compromise the safety of the patient, at the discretion of the investigator -Patients who have any severe and/or uncontrolled medical conditions such as: • unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction = 6 months prior to randomization, serious uncontrolled cardiac arrhythmia, • uncontrolled diabetes as defined by fasting serum glucose >2X ULN. • active or uncontrolled severe infection. • cirrhosis, chronic active hepatitis or chronic persistent hepatitis • severely impaired lung function -Previous treatment with erlotinib and/ or gemcitabine -Patients with a known hypersensitivity to metformin -Use of metformin in the previous 6 months
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 the EGFR tyrosine kinase inhibitor erlotinb and metformin, combined with gemcitabine in patients with metatastatic pancreatic cancer.;Secondary Objective: -Progression free survival -Objective response rate -Toxicity profile -Pharmacodynamics: biomarkers in blood and tumour tissue;Primary end point(s): survival after 6 months | — |
Countries
Netherlands
Outcome results
None listed