• Seminars in oncology · Jun 1996

    Multicenter Study Clinical Trial

    Ifosfamide-based combination chemotherapy in advanced non-small cell lung cancer: two phase I studies.

    • P C Hoffman, G A Masters, L C Drinkard, S A Krauss, B L Samuels, H M Golomb, and E E Vokes.
    • Department of Medicine, The University of Chicago, Louis A. Weiss Memorial Hospital, IL 60637, USA.
    • Semin. Oncol. 1996 Jun 1; 23 (3 Suppl 6): 11-5.

    AbstractTwo studies were performed to determine the maximum tolerated dose (MTD) of paclitaxel and vinorelbine, respectively, in combination with a fixed dose of ifosfamide in previously untreated patients with stage IIIB or IV non-small cell lung cancer. Response rate and survival were also assessed. Both regimens were given with mesna and granulocyte colony-stimulating factor support. The maximum tolerated dose of paclitaxel in combination with 1.6 g/m2/d X 3 ifosfamide was 300 mg/m2, and the recommended dose for phase II study is 250 mg/m2. Among 31 patients treated with ifosfamide/paclitaxel, there were seven partial responses; additionally, 10 patients had either minor regression or stable disease. The maximum tolerated dose of vinorelbine in combination with 1.6 g/m2/d X 3 ifosfamide was 35 mg/m2/d X 3, and the recommended dose for phase II study is 30 mg/m2/d X 3. Among 42 patients treated with ifosfamide/vinorelbine, responses have been encouraging, and final analysis is pending. The dose-limiting toxicity for both regimens was neutropenia. These findings indicate that ifosfamide-containing combination chemotherapy regimens have activity in advanced non-small cell lung cancer and are well tolerated when administered with granulocyte colony-stimulating factor.

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