Stage IV Pancreatic Cancer Clinical Trial
Official title:
Ipilimumab and Gemcitabine for Advanced Pancreas Cancer: A Phase Ib Study
This phase I trial studies the side effects and best dose of ipilimumab when given together with gemcitabine hydrochloride in treating patients with stage III-IV or recurrent pancreatic cancer that cannot be removed by surgery. Monoclonal antibodies, such as ipilimumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or tumor-killing substances to them. Drugs used in chemotherapy, such as gemcitabine hydrochloride, work in different ways to kill tumor cells or stop them from growing. Giving monoclonal antibody therapy together with chemotherapy may kill more tumor cells.
OUTLINE: This is a dose-escalation study of ipilimumab.
INDUCTION: Patients receive ipilimumab intravenously (IV) over 90 minutes in weeks 1, 4, 7,
and 10, and gemcitabine hydrochloride IV over 30 minutes in weeks 1-7 and 9-11.
MAINTENANCE: Beginning in week 22, patients receive ipilimumab IV over 90 minutes once every
12 weeks and gemcitabine hydrochloride IV over 30 minutes once weekly for 3 weeks. Courses
repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Treatment modifications may apply according to response.
After completion of study treatment, patients are followed up monthly for 6 months and then
every 3 months.
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