An open-label clinical trial evaluating safety and pharmacokinetics of two dosing schedules of panitumumab in patients with solid tumors

Joe J. Stephenson, Charles Gregory, Howard Burris, Tim Larson, Udit Verma, Allen Cohn, Jeffrey Crawford, Roger B. Cohen, Julie Martin, Peggy Lum, Xinqun Yang, Rafael G. Amado

Research output: Contribution to journalArticle

33 Scopus citations

Abstract

Purpose: This study evaluated safety, pharmacokinetics, and efficacy of 2 dose schedules and 2 infusion times of panitumumab in patients with advanced solid malignancies. Patients and Methods: This phase I multicenter, open-label study sequentially enrolled patients with advanced solid tumors refractory to standard therapy, or for which no standard therapy exists, to receive panitumumab 6 mg/kg every 2 weeks or 9 mg/kg every 3 weeks. Patients receiving panitumumab every 2 weeks received either all infusions over 60 minutes or a 60-minute infusion for the first dose followed by 30-minute infusions if the first infusion was well tolerated. Patients in the every-3-week cohort received 60-minute infusions. Safety outcomes included the incidence of adverse events and antipanitumumab antibody formation. Pharmacokinetic properties were determined. Efficacy endpoints included response rate and duration of response. Results: Eighty-six patients were enrolled; 84 (98%) received panitumumab. Treatment-related adverse events occurred in 90% of patients. Safety profiles were similar between patients receiving 30-minute (n = 20) and 60-minute (n = 43) infusions every 2 weeks and patients receiving panitumumab every 3 weeks (n = 21). Panitumumab exposure at steady state increased dose proportionally, and peak serum concentrations were similar in patients receiving either 30- or 60-minute infusions every 2 weeks. Objective responses were seen in 4 patients (5%) with colon, rectal, esophageal, and bladder cancers. Conclusion: Similar drug exposures and safety profiles were observed in patients receiving panitumumab 6 mg/kg every 2 weeks with either 30- or 60-minute infusions and antitumor activity was seen in some patients. Exposure increased approximately dose proportionally at steady state.

Original languageEnglish (US)
Pages (from-to)29-37
Number of pages9
JournalClinical Colorectal Cancer
Volume8
Issue number1
DOIs
Publication statusPublished - 2009

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Keywords

  • Anti-epidermal growth factor receptor
  • Cetuximab
  • Monoclonal antibody
  • Targeted therapy

ASJC Scopus subject areas

  • Oncology
  • Gastroenterology

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