Biologically Optimized Infusion Schedule of Gemcitabine and Nab-Paclitaxel for the Treatment of Metastatic Pancreatic Cancer
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Metastatic Pancreatic Adenocarcinoma
- Stage IV Pancreatic Cancer AJCC v8
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
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 relati...
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.
Tracking Information
- NCT #
- NCT04115163
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Principal Investigator: Laith Abushahin, MBBS Ohio State University Comprehensive Cancer Center
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