Status:
COMPLETED
Metformin Combined With Chemotherapy for Pancreatic Cancer
Lead Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Conditions:
Locally Advanced Pancreatic Cancer
Metastatic Pancreatic Cancer
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
Pancreatic cancer patients have one of the worst prognoses among all cancer types with a 5 year survival rate of less than 5%. Despite significant changes during the last decade in our molecular knowl...
Detailed Description
In this phase II randomized, placebo controlled study, patients with locally advanced or metastatic pancreatic cancer will be randomized to treatment with gemcitabine, erlotinib and metformin, or gemc...
Eligibility Criteria
Inclusion
- Signed informed content obtained prior to treatment
- Cytological or histological confirmed carcinoma of the pancreas
- Metastatic cancer
- Measurable lesion according to RECIST criteria
- ECOG/ WHO performance 0-2
- Age \> 18 years
- 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
- 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:
- 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
- Previous treatment with gemcitabine for metastatic disease
- Previous treatment with gemcitabine combined with radiotherapy for locally advanced pancreatic cancer within 6 months prior to study entry
- Patients with a known hypersensitivity to metformin
- Use of metformin in the previous 6 months
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2014
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT01210911
Start Date
August 1 2010
End Date
April 1 2014
Last Update
April 21 2021
Active Locations (1)
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1
Academic Medical Center
Amsterdam, Netherlands, 1105AZ