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Originally published as JCO Early Release 10.1200/JCO.2003.09.140 on July 28 2003

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Journal of Clinical Oncology, Vol 21, Issue 18 (September), 2003: 3402-3408
© 2003 American Society for Clinical Oncology

Randomized Phase II Comparison of Dose-Intense Gemcitabine: Thirty-Minute Infusion and Fixed Dose Rate Infusion in Patients With Pancreatic Adenocarcinoma

Margaret Tempero, William Plunkett, Veronique Ruiz van Haperen, John Hainsworth, Howard Hochster, Renato Lenzi, James Abbruzzese

From the University of California San Francisco, San Francisco, CA; University of Texas M.D. Anderson Cancer Center, Houston, TX; Sarah Cannon Cancer Center, Nashville, TN; New York University Medical Center, New York, NY; and the Hague, the Netherlands.

Address reprint requests to Margaret Tempero, MD, Deputy Director, University of California San Francisco Comprehensive Cancer Center, 1600 Divisadero St, B726, UC Box 1770, San Francisco, CA 94115; e-mail: mtempero{at}medicine.ucsf.edu.

Purpose: To conduct a randomized phase II trial of dose-intense gemcitabine using a standard 30-minute infusion or the fixed dose rate (FDR) infusion (10 mg/m2/min) in patients with pancreatic adenocarcinoma.

Patients and Methods: In this prospective trial, patients with locally advanced and metastatic pancreatic adenocarcinoma were treated with 2,200 mg/m2 gemcitabine over 30 minutes (standard arm) or 1,500 mg/m2 gemcitabine over 150 minutes (FDR arm) on days 1, 8, and 15 of every 4-week cycle. The primary end point of this trial was time to treatment failure. Secondary end points included time to progression, median survival, safety, and pharmacokinetic studies of gemcitabine.

Results: Ninety-two patients were enrolled onto this study; 91% of the patients had metastatic disease. Time to treatment failure was comparable in both treatment groups; however, the median survival for all patients was 5.0 months in the standard arm and 8.0 months in the FDR arm (P = .013). For patients with metastases, the median survival was 4.9 months in the standard arm and 7.3 months in FDR arm (P = .094). The 1- and 2-year survival rates for all patients were 9% (standard arm) versus 28.8% (FDR; P = .014) and 2.2% (standard arm) versus 18.3% (FDR; P = .007), respectively. Patients in the FDR infusion arm experienced consistently more hematologic toxicity. Pharmacokinetic analyses demonstrated a two-fold increase in intracellular gemcitabine triphosphate concentration in the FDR arm (P = .046).

Conclusion: Pharmacokinetic and clinical data in this trial supports the continued evaluation of the FDR infusion strategy with gemcitabine.

Financial support for this study was provided by Eli Lilly and Co, Indianapolis, IN.

Presented in part at the Annual Meeting of the American Society of Clinical Oncology, Atlanta, GA, May 15–18, 1999.


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