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A phase 2 study of TZT-1027, administered weekly to patients with advanced non-small cell lung cancer following treatment with platinum-based chemotherapy.

作者信息

Riely Gregory J, Gadgeel Shirish, Rothman Ivan, Saidman Bruce, Sabbath Kert, Feit Kevie, Kris Mark G, Rizvi Naiyer A

机构信息

Thoracic Oncology Service, Department of Medicine, Memorial Sloan-Kettering Cancer Center, New York, NY 10021, USA.

出版信息

Lung Cancer. 2007 Feb;55(2):181-5. doi: 10.1016/j.lungcan.2006.10.002. Epub 2006 Nov 7.

DOI:10.1016/j.lungcan.2006.10.002
PMID:17092603
Abstract

INTRODUCTION

: TZT-1027, a derivative of dolastatin-10, has a wide spectrum of in vitro activity against cancer cell lines. We conducted a phase 2 trial of TZT-1027 in patients with previously treated non-small cell lung cancer (NSCLC).

PATIENTS AND METHODS

Patients with stage IV or recurrent NSCLC who had received one prior platinum-based chemotherapy regimen were eligible. Patients received 2.4mg/m(2) of TZT-1027 on days 1 and 8 of a 21-day cycle. The primary endpoint was response rate as measured by RECIST.

RESULTS

Thirty-two patients were enrolled (16 women, 16 men). The most common grade 3/4 adverse effects were leukopenia and neutropenia. Four patients died within 30 days of receiving TZT-1027, three from progressive disease and one with pneumonia and neutropenia. No objective response was observed (0% observed rate, 95% confidence interval 0-11%). The median time to progression was 1.5 months. The median overall survival was 8.5 months.

CONCLUSIONS

This phase 2 trial showed that TZT-1027 administered on days 1 and 8 of a 21-day cycle had no anticancer activity. Further development of TZT-1027 in patients with previously treated NSCLC is not warranted.

摘要

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