Spots Global Cancer Trial Database for Pioglitazone as Second-Line in Patients With Metastatic Pancreatic Cancer After Treatment With Gemcitabine

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Trial Identification

Brief Title: Pioglitazone as Second-Line in Patients With Metastatic Pancreatic Cancer After Treatment With Gemcitabine

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

Study ID: NCT00867126

Conditions

Pancreatic Cancer

Interventions

pioglitazone hydrochloride

laboratory biomarker analysis

questionnaire administration

quality-of-life assessment

Study Description

Brief Summary: 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.

Detailed Description: 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.