This pilot phase II trial studies how well pioglitazone hydrochloride works in treating patients with pancreatic cancer. Pioglitazone hydrochloride may slow the growth of tumor cells and may be an effective treatment for pancreatic cancer.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT01838317.
PRIMARY OBJECTIVES:
I. Describe change in markers of insulin resistance, including in adiponectin levels standard glucose tolerance test, and serum levels of insulin and glucose in patients with pancreas cancer receiving pioglitazone (pioglitazone hydrochloride).
SECONDARY OBJECTIVES:
I. To determine the tumor response by Response Evaluation Criteria in Solid Tumors (RECIST) in patients with pancreas cancer receiving pioglitazone.
II. To describe changes in weight in patients with pancreas cancer receiving pioglitazone.
III. To describe changes in Eastern Cooperative Oncology Group (ECOG) performance status in patients with pancreas cancer receiving pioglitazone.
IV. To describe changes in symptoms and quality of life using the Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) scale, version 4.
V. Compare change in blood biomarkers and magnetic resonance imaging (MRI) between the pioglitazone and control arms.
OUTLINE: Patients are assigned to 1 of 2 treatment arms.
ARM I: Patients receive pioglitazone hydrochloride orally (PO) once daily (QD) on days 1-28. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity.
ARM II: Patients receive treatment per standard of care at the discretion of the treating team.
After completion of study treatment, patients are followed up at 2 weeks and then periodically.
Lead OrganizationUT Southwestern/Simmons Cancer Center-Dallas
Principal InvestigatorMuhammad Shaalan Beg
