A phase I-II study of bi-weekly gemcitabine and irinotecan as second-line chemotherapy in non-small cell lung cancer after prior taxane + platinum-based regimens

Cancer Chemotherapy and Pharmacology
Christos KosmasHaralambos P Kalofonos

Abstract

Treatment options in patients with recurrent non-small cell lung cancer (NSCLC) remain limited as a result of poor activity of most agents after failure of platinum-based therapy. In the present phase I-II study, we evaluated the feasibility and efficacy of bi-weekly gemcitabine (GEM) + irinotecan (CPT-11) in patients with relapsed NSCLC. Patients with advanced NSCLC, WHO-performance status (PS) </= 2, prior taxane/platinum-based chemotherapy were eligible. Chemotherapy was administered in a dose-escalated fashion in subgroups of 3-6 patients until dose-limiting toxicity (DLT) was encountered as follows: CPT-11 150 or 180 mg/m(2) followed by GEM 1,200-1,800 mg/m(2), both on days 1 + 15, recycled every 28 days in four dose levels (DLs). Forty-nine patients entered the phase I and II part of the study (phase I: 12-phase II: 37 + 3 at DL-3), and 40 patients were evaluable for a response in phase II and all for toxicity: median age, 61 years (range 36-74); PS, 1 (0-2); gender, 43 males/6 females-histologies; adenocarcinoma, 25; squamous, 20; large cell, 4. Metastatic sites included lymph nodes, 38; bone, 5; liver, 4; brain, 3; lung nodules, 14; adrenals, 13; other, 3. All patients had prior taxane + platinum-based treatment, and 42...Continue Reading

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Jun 5, 2010·Japanese Journal of Clinical Oncology·Takayasu KurataMasahiro Fukuoka
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