A Phase II Study of Pioglitazone for Patients With Cancer of the Pancreas

A Phase II Study of Pioglitazone for Patients With Cancer of the Pancreas

This study is being done to determine whether or not addition of the oral medication, pioglitazone to standard chemotherapy, results in improvement of blood tests that measure the body's ability to utilize sugar (glucose and insulin metabolism). In addition the investigators want to determine whether or not treatment with pioglitazone results in (1) improvement in the size of the tumor, (2) weight gain, (3) improved ability to function during the day and (4) quality of life.

Inclusion Criteria:

• Signed informed consent
• Histologically proven adenocarcinoma of the pancreas
• Radiologically measurable disease
• ECOG functional status 0-2

Exclusion Criteria:

• Prior radiation therapy for pancreatic cancer If chemotherapy is planned, new chemotherapy regimen should have started more than 14 days prior to enrollment
• Surgery or radiation planned within 8 weeks of starting therapy
• Prior exposure to Thiazolidinedione (TZD) therapy in the past 12 months
• Hypersensitivity of TZD
• New York heart association class III/IV heart failure.
• Known HIV positive
• Pregnant or lactating women
• History of, or active bladder cancer
• Inadequate hepatic function documented within 14 days of enrollment
• Total bilirubin level > 1.5 x ULN
• AST and ALT > 2.5 x ULN, unless there are liver metastases in which case AST and ALT or > 5 x ULN