Pancreatic Cancer, Metastatic Clinical Trial
Official title:
Phase I/II Trial of OSI-906 in Combination With Gemcitabine and Erlotinib in Patients With Metastatic Ductal Adenocarcinoma of the Pancreas
OSI-906 is a new drug that may stop cancer cells from growing abnormally. This drug has been
used in other research studies and information from those suggests that OSI-906 may help
block cell receptors involved in tumor growth.
Gemcitabine and erlotinib are used as standard treatment for pancreatic cancer. In this
research study, the investigators are looking for the highest dose of OSI-906 that can be
given safely in combination with gemcitabine and erlotinib. This dose will then be given
together with gemcitabine and erlotinib to a further group of patients with pancreatic
cancer.
This study will be conducted in two parts: a phase I study and a phase II study. In both
instances, a treatment cycle is 28 days (4 weeks). Subjects will take OSI-906 by mouth,
twice a day, every day. Subjects will receive gemcitabine through an IV in clinic over 30
minutes on days 1, 8 and 15 of each 28-day cycle. Subjects will take erlotinib by mouth,
once a day, every day.
At every visit subjects will have a physical exam and blood tests. An EKG will be done on
days 1, 8 and 15 of cycle 1 and on day 1 of all subsequent cycles. A CT scan will be done
every 2 cycles (8 weeks).
Subjects will complete a daily drug diary and perform glucose monitoring (finger stick) once
daily at home.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment