Clinical trialEPhase 1Terminated
Pioglitazone as Second-Line in Patients With Metastatic Pancreatic Cancer After Treatment With Gemcitabine
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
- Outcome
- Stopped earlylow accrual (Enrollment)
- Phase
- EPhase 1
- Status
- Terminated
- Study type
- Interventional
- Start
- 2 March 2009
- Expected end
- February 2012
- Enrollment
- 6 participants
- Sites
- 1
- Primary outcomes
- 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; Fasting serum glucose and insulin levels as measured at baseline, every 4 weeks during therapy, and then at the completion of therapy; Changes in weight as measured at baseline, every 4 weeks during therapy, at the completion of therapy, and then monthly for 6 months and every 3 months for 2 years; Changes in ECOG performance status as measured at baseline, weekly during the first course of therapy, every 4 weeks during the rest of therapy, at the completion of therapy, and then monthly for 6 months and every 3 months for 2 years; Changes in symptoms and quality of life as measured by the validated FACT-Hep scale version 4 questionnaire at baseline, every 4 weeks during therapy, and then at the completion of therapy
- Sponsor
- Other
- Results posted
- No
- Last update
- 26 November 2018
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Brief summary public domain (ClinicalTrials.gov)
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 public domain (ClinicalTrials.gov)
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.