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Annals of Oncology Advance Access published online on November 9, 2005
Annals of Oncology, doi:10.1093/annonc/mdj055
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© 2005 European Society for Medical Oncology
Received July 29, 2005
Revised September 20, 2005
Accepted September 26, 2005

original article

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. Kurup 1, C.-W. Lin 2, D. J. Murry 2, L. Dobrolecki 3, D. Estes 1, C. T. Yiannoutsos 1, L. Mariano 1, C. Sidor 4, R. Hickey 3, and N. Hanna 1*

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

* To whom correspondence should be addressed.
N. Hanna, E-mail: nhanna{at}iupui.edu


  Abstract

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.

Keywords: angiogenesis; carboplatin; lung cancer; paclitaxel; rhAngiostatin.
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