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

Phase 2

Completed

Conditions: metastatic pancreatic cancer
10017991

Registration Number: NL-OMON34831

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 120

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

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

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Survival after 6 months.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>-Progression free survival<br /><br>-Objective response rate<br /><br>-Toxicity profile<br /><br>-Pharmacodynamics: biomarkers in blood and tumour tissue</p><br>