Randomized Phase II Comparison of Dose-Intense Gemcitabine: Thirty-Minute Infusion and Fixed Dose Rate Infusion in Patients With Pancreatic Adenocarcinoma
作者： Margaret Tempero , William Plunkett , Veronique Ruiz van Haperen , John Hainsworth , Howard Hochster
关键词: Metastatic Pancreatic Adenocarcinoma 、 Surgery 、 Clinical endpoint 、 Gemcitabine 、 Randomized controlled trial 、 Medicine 、 Survival rate 、 Urology 、 Pancreatic disease 、 Chemotherapy 、 Randomization
摘要: Purpose: To conduct a randomized phase II trial of dose-intense gemcitabine using standard 30-minute infusion or the fixed dose rate (FDR) (10 mg/m2/min) in patients with pancreatic adenocarcinoma. Patients and Methods: In this prospective trial, locally advanced metastatic adenocarcinoma were treated 2,200 mg/m2 over 30 minutes (standard arm) 1,500 150 (FDR on days 1, 8, 15 every 4-week cycle. The primary end point was time to treatment failure. Secondary points included progression, median survival, safety, pharmacokinetic studies gemcitabine. Results: Ninety-two enrolled onto study; 91% had disease. Time failure comparable both groups; however, survival for all 5.0 months arm 8.0 FDR (P = .013). For metastases, medi...
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