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Annals of Oncology Advance Access originally published online on November 9, 2005
Annals of Oncology 2006 17(1):97-103; doi:10.1093/annonc/mdj055
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© 2005 European Society for Medical Oncology

Recombinant human angiostatin (rhAngiostatin) in combination with paclitaxel and carboplatin in patients with advanced non-small-cell lung cancer: a phase II study from Indiana University

A. Kurup1, C.-W. Lin3, D. J. Murry3, L. Dobrolecki2, D. Estes1, C. T. Yiannoutsos1, L. Mariano1, C. Sidor4, R. Hickey2 and N. Hanna1,*

1 Indiana University School of Medicine; 2 Indiana University, Indianapolis, IN; 3 University of Iowa, College of Pharmacy, Iowa City, IA; 4 EntreMed, Inc., Rockville, MD, USA

* Correspondence to: Dr N. H. Hanna, Indiana University, 535 Barnhill Drive, RT 473, Indianapolis, IN 46202, USA. Tel: +1-317-274-3515; Fax: +1-317-274-3646; E-mail: nhanna{at}iupui.edu

Background: Recombinant human angiostatin (rhAngiostatin) functions as a potent inhibitor of angiogenesis. This study combined rhAngiostatin with a standard chemotherapy regimen in patients with advanced non-small-cell lung cancer (NSCLC).

Patients and methods: Eligible patients had chemotherapy-naïve stage IIIB (with pleural effusion) or IV NSCLC, performance status (PS) 0 or 1, no history of bleeding, brain metastasis or requirements for anti-coagulation. Patients received carboplatin (AUC 5) intravenously and paclitaxel (175 mg/m2) intravenously day 1 + subcutaneous rhAngiostatin at either 15 mg or 60 mg twice daily. Cycles were repeated every 3 weeks, for up to six cycles. Patients without progression after completing at least four cycles were continued on maintenance rhAngiostatin until disease progression.

Results: Patient characteristics (n = 24) were: 16 males, median age 66 years (range 45–78), 54% PS 1, 83.3% stage IV and 62.5% adenocarcinoma. Grade 3/4 toxicities included: fatigue 47.8%, neutropenia 39.1%, dyspnea 39.1%, vascular 26.1% and infection 17.4%. The overall response rate was 39.1%, 39.1% stable disease and 21.7% progressive disease. Median time to progression was 144 days, and 1-year survival was 45.8%.

Conclusions: rhAngiostatin in combination with paclitaxel and carboplatin is feasible and results in a high disease control rate in patients with advanced NSCLC.

Key words: angiogenesis, carboplatin, lung cancer, paclitaxel, rhAngiostatin


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