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 Metastatic Pancreatic Cancer
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 gemcitabine, erlotinib and placebo.
Gemcitabine at a dose of 1000 mg/m2 (iv, 30 minutes) will be given weekly, for 3 weeks,
followed by one week without treatment. Erlotinib will be administered at a daily dose of
100 mg at least one hour before or 2 hours after the ingestion of food. Metformin/ placebo
will be administered at a dose of 500 mg twice daily. If well tolerated the dose will be
increased to 1000 mg twice daily in the second week.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Survival after 6 months
6 months after completion of the study
Hanneke Wilmink, MD, PhD
Academic Medical Center, Amsterdam
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)