A Pilot Study of Pioglitazone as Second Line Therapy for Patients With Previously Treated Metastatic Adenocarcinoma of the Pancreas With Disease Progression After Gemcitabine Based Chemotherapy
- To describe changes in markers of insulin resistance, including serum adiponectin
levels, standard glucose tolerance testing, and fasting serum glucose and insulin
levels, in patients with previously treated metastatic adenocarcinoma of the pancreas
treated with pioglitazone hydrochloride as second-line therapy.
- To describe changes in weight in these patients.
- To describe changes in ECOG performance status in these patients.
- To describe changes in symptoms and quality of life of these patients using the
validated FACT-Hep scale version 4 questionnaire.
- To determine the tumor response as measured by RECIST criteria in these patients.
- To determine the time to disease progression in these patients.
OUTLINE: Patients receive oral pioglitazone hydrochloride once daily on days 1-28. Courses
repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients complete a quality-of-life questionnaire at baseline, every 4 weeks during therapy,
and then at the completion of therapy.
Patients undergo blood sample collection at baseline, every 4 weeks during therapy, and then
at the completion of therapy for laboratory biomarker studies. Samples are analyzed for
levels of insulin resistance markers (adiponectin, glucose, and insulin).
After completion of study therapy, patients are followed monthly for 6 months and then every
3 months for 2 years.
Primary Purpose: Treatment
Insulin resistance markers as measured by standard glucose tolerance testing and serum adiponectin levels at baseline, every 4 weeks during therapy, and then at the completion of therapy
Yull E. Arriaga, MD
Simmons Cancer Center
|Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas||Dallas, Texas 75390|