title: 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.
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).
  
  
  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.
authors.affiliation: Indiana University School of Medicine, Indianapolis, IN 46202, USA.
authors.forename: A
authors.initials: A
authors.lastname: Kurup
authors.forename: C -W
authors.initials: C-
authors.lastname: Lin
authors.forename: D J
authors.initials: DJ
authors.lastname: Murry
authors.forename: L
authors.initials: L
authors.lastname: Dobrolecki
authors.forename: D
authors.initials: D
authors.lastname: Estes
authors.forename: C T
authors.initials: CT
authors.lastname: Yiannoutsos
authors.forename: L
authors.initials: L
authors.lastname: Mariano
authors.forename: C
authors.initials: C
authors.lastname: Sidor
authors.forename: R
authors.initials: R
authors.lastname: Hickey
authors.forename: N
authors.initials: N
authors.lastname: Hanna
mesh_terms: D000368:Aged; D043168:Angiostatins / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001932:Brain Neoplasms / Q000188:drug therapy / Q000378:metabolism / Q000556:secondary; D016190:Carboplatin / Q000008:administration & dosage; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000378:metabolism; D018450:Disease Progression; D018572:Disease-Free Survival; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000378:metabolism; D008297:Male; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D009367:Neoplasm Staging; D017239:Paclitaxel / Q000008:administration & dosage; D040901:Proteomics; D011994:Recombinant Proteins / Q000627:therapeutic use*; D015996:Survival Rate; D013997:Time Factors
chemical_list: D011994:Recombinant Proteins; D043168:Angiostatins; D016190:Carboplatin; D017239:Paclitaxel