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Originally published as JCO Early Release 10.1200/JCO.2008.20.4826 on May 18 2009 © 2009 American Society of Clinical Oncology. Safety and Efficacy of Patupilone in Patients With Advanced Ovarian, Primary Fallopian, or Primary Peritoneal Cancer: A Phase I, Open-Label, Dose-Escalation Study
From the Netherlands Cancer Institute, Amsterdam; Medisch Spectrum Twente, Enschede, the Netherlands; Narodny Onkologicky Ustav; Onkologicky Ustave sv. Alzbety, s.r.o., Bratislava; East Slovak Oncology Institute, a.s., Ko Corresponding author: Amit M. Oza, MD (Lon), FRCP, FRCPC, Princess Margaret Hospital, University Health Network, University of Toronto, 610 University Ave 5-700, Toronto, Ontario, Canada, M5G 2M9; e-mail: Amit.Oza{at}unh.on.ca. Purpose To evaluate the safety, maximum tolerated dose (MTD), and pharmacokinetics of patupilone administered once every 3 weeks with proactive standardized diarrhea management in patients with resistant or refractory ovarian, fallopian, or peritoneal cancer. Patients and Methods Patients received patupilone (6.5 to 11.0 mg/m2) every 3 weeks via 20-minute infusion. Adverse events, dose-limiting toxicities (DLT), MTD, and tumor response were determined. The tumor response was measured by Response Evaluation Criteria in Solid Tumors (RECIST) and cancer antigen 125 levels. Results Forty-five patients were enrolled. Adverse events were mild to moderate in intensity, and grade 3 diarrhea (13%) was the most commonly reported serious adverse event. Grade 3 peripheral neuropathy was noted in two patients (4%). Diarrhea, peripheral neuropathy, and fatigue were the most common DLTs; however, these were uncommon in the first cycle and the MTD was therefore not reached in this study. Overall response (OR; complete and partial responses; median cycles, 8) per RECIST in patients with measurable disease (n = 36) was 19.5%. Median duration of disease stabilization (complete and partial responses and stable disease) was 15.8 months. These results appear improved from a previous study in a similar patient population using a weekly schedule (2.5 mg/m2/week; N = 53; OR, 5.7%). Conclusion Patupilone once every 3 weeks was well-tolerated at doses up to 11.0 mg/m2. Patupilone demonstrated promising antitumor activity in patients with drug-resistant/refractory disease. An ongoing phase III study in this patient population is testing the 10.0 mg/m2 dose. Supported by Novartis Pharmaceuticals Corporation (clinical studies and medical editorial assistance). Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article. Clinical Trials repository link available JCO.org. Clinical trial information can be found for the following: NCT00035100 [ClinicalTrials.gov] .
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Copyright © 2009 by the American Society of Clinical Oncology, Online ISSN: 1527-7755. Print ISSN: 0732-183X
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ice, Slovakia; The Juravinski Cancer Centre, Hamilton; Princess Margaret Hospital, Toronto, Ontario, Canada; The Royal Marsden Hospital, Sutton, Surrey, United Kingdom; and Novartis Pharmaceuticals Corporation, East Hanover, NJ.
