Metastatic Pancreatic Adenocarcinoma Clinical Trial
Official title:
A Pilot Study of Biologically Optimized Infusion Schedule of Gemcitabine and Nab-Paclitaxel in Metastatic Pancreatic Adenocarcinoma
This phase II trial studies how well a biologically optimized infusion schedule of gemcitabine and nab-paclitaxel works in treating patients with pancreatic cancer that has spread to other places in the body (metastatic). Drugs used in chemotherapy, such as gemcitabine and nab-paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Altering the timing of the nab-paclitaxel infusion may improve response in patients with pancreatic cancer.
PRIMARY OBJECTIVE: I. To report overall response rate (ORR) for the optimized schedule according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 guidelines. SECONDARY OBJECTIVES: I. To report toxicity of the infusion schedule. II. To report disease control rate. III. To calculate relative dose intensity. IV. To report the overall survival (OS). V. To report progression free survival (PFS). VI. To correlate exploratory biomarkers with clinical outcomes. OUTLINE: Patients receive gemcitabine intravenously (IV) over 30 minutes on days 1 and 15 and nab-paclitaxel IV over 30 minutes on days 3 and 17. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up monthly for 3 months and then every 3 months thereafter. ;
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