PMID: 11325490Apr 28, 2001Paper

Phase I study of gemcitabine and carboplatin in advanced non-small cell lung carcinoma

Lung Cancer : Journal of the International Association for the Study of Lung Cancer
A GajraS L Graziano

Abstract

This phase I study was designed to determine the maximum tolerated dose of carboplatin with a fixed dose of gemcitabine without growth factor or hematopoietic precursor support. Nineteen patients with previously untreated non-small cell lung cancer (NSCLC) were treated at three dose levels. Initially, the gemcitabine dose was 1000 mg/m(2) given on days 1 and 8. Of the first five patients treated with carboplatin AUC 4, three experienced dose limiting toxicity (DLT). The study was, therefore, amended to decrease the dose of gemcitabine to 800 mg/m(2) given on days 1 and 8 in a 21-day cycle. Dose limiting toxicity (neutropenia and thrombocytopenia) were seen at dose level 2A (carboplatin AUC=5). Thus, no further dose escalation was performed. Grade 3 and 4 toxicities were seen as follows: leukopenia in five of 18 (28%); neutropenia, four of 18 (22%); and thrombocytopenia, four of 18 (22%) evaluable patients. Grade 3 or 4 anemia occurred in one of 18 (6%) patients and no neutropenic fever or treatment related mortality was observed. Partial responses were seen in six patients and one patient with evaluable disease had an objective response. The overall response rate was 37% (seven of 19). Six other patients had stable disease. A t...Continue Reading

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Citations

Apr 17, 2002·Lung Cancer : Journal of the International Association for the Study of Lung Cancer·Pascal ThomasJ P Kleisbauer
Nov 15, 2002·Lung Cancer : Journal of the International Association for the Study of Lung Cancer·Martin J Edelman
Jun 27, 2003·Lung Cancer : Journal of the International Association for the Study of Lung Cancer·Paola MazzantiTullio Battelli
Oct 9, 2007·American Journal of Clinical Oncology·Arkadiusz Z DudekPriya Kumar
Nov 27, 2007·Expert Opinion on Pharmacotherapy·Sylke NagelFiona Blackhall

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