Pancreatic Cancer Clinical Trial
Official title:
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
RATIONALE: Pioglitazone may slow the growth of tumor cells and may be an effective treatment
for pancreatic cancer.
PURPOSE: This phase I trial is studying how well pioglitazone works as second-line therapy in
treating patients with metastatic pancreatic cancer that progressed after treatment with
gemcitabine.
OBJECTIVES:
Primary
- 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.
Secondary
- 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.
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