A phase I/II study of pemetrexed vinorelbine in patients with non-small cell lung cancer

S.J. Clarke, M.J. Boyer, Michael Millward, C. Underhill, E. Moyland, D. Yip, S. White, A. Childs, P. Beale, J. Latz, A. Suri, J.L. Iglesias

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    28 Citations (Scopus)


    Purpose: Pemetrexed and vinorelbine are active antineoplastic agents in non-small cell lung cancer (NSCLC). Phase I objectives include maximum tolerated dose (MTD) and recommended phase II dose determination, and pharmacokinetics of the pemetrexed-vinorelbine doublet in locally advanced or metastatic solid tumor patients (pts). Phase II objectives include tumor response evaluation, efficacy, and toxicity for first-line treatment of advanced NSCLC. Experimental design: Phase I pts received pemetrexed (day 1, 300-700 mg/ m(2)) and vinorelbine (days 1 and 8, 15-30 mg/m(2)) every 21 days. Pharmacokinetics determined at cycle 1. Beginning with dose-level 3, folic acid and Vitamin B-12 supplementation were given. Results: Thirty-one phase I pts were enrolled. MTD was pemetrexed 700mg/m(2) and vinorelbine 30mg/m(2); and recommended phase II dose was pemetrexed 500mg/m(2) and vinorelbine 30 mg/m(2). When administered in combination, pemetrexed and vinorelbine pharmacokinetics were consistent with single-agent administration. Thirty-seven (36 chemonaive) phase II NSCLC pts received pemetrexed-vinorelbine. Evaluable tumor response was 40%, with intent-to-treat 38%. One drug-related death occurred from febrile neutropenia with Staphylococcal infection. Grade 3/4 hematologic toxicities were neutropenia (65%) and febrile neutropenia (11%), white prevalent grade 3/4 non-hematologic toxicity was fatigue (27%). Conclusion: The pemetrexed-vinorelbine combination is well tolerated and shows activity as first-line treatment in advanced NSCLC patients. (c) 2005 Elsevier Ireland Ltd. All rights reserved.
    Original languageEnglish
    Pages (from-to)online - approx 5-20pp
    JournalLung Cancer
    Issue number3
    Publication statusPublished - 2005


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