A phase II, randomized, placebo controlled study to evaluate the efficacy of the combination of gemcitabine, erlotinib and metformin in patients with locally advanced and metastastatic pancreatic cancer - metformin and pancreatic cancer

Conditions: locally advanced and metastatic pancreatic cancer
MedDRA version: lltLevel: LLTClassification code 10033604Term: <Manually entered code. Term in E.1.1>

Registration Number: EUCTR2009-017716-32-NL

Lead Sponsor: Academic Medical Center

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

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 < 150 µmol/L and/ or a creatinine clearance > 60 ml/ L)
-Adequate liver function (bilirubin < 1.5 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

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

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 the EGFR tyrosine kinase inhibitor erlotinb and metformin, combined with gemcitabine in patients with metatastatic pancreatic cancer.;Secondary Objective: -Progression free survival<br>-Objective response rate <br>-Toxicity profile<br>-Pharmacodynamics: biomarkers in blood and tumour tissue;Primary end point(s): survival after 6 months

Secondary Outcome Measures