title: A phase II trial of nab-paclitaxel (ABI-007) and carboplatin in patients with unresectable stage IV melanoma : a North Central Cancer Treatment Group Study, N057E(1).
abstract: BACKGROUND
  There is increasing evidence that paclitaxel and carboplatin are clinically active in the treatment of metastatic melanoma (MM). ABI-007 is an albumin-bound formulation of paclitaxel that has demonstrated single-agent activity against metastatic melanoma.
  
  
  METHODS
  A parallel phase II trial was conducted in patients with unresectable stage IV melanoma who were either chemotherapy naive (CN) or previously treated (PT). The treatment regimen consisted of ABI-007 (100 mg/m(2) ) and carboplatin area under the curve (AUC2) administered on days 1, 8, and 15 every 28 days. The primary aim of this study was objective response rate (RECIST).
  
  
  RESULTS
  Seventy-six patients (41 CN and 35 PT) were enrolled between November 2006 and July 2007. Three patients withdrew consent prior to starting treatment. The median number of treatment cycles was 4. There were 10 (25.6%) responses (1 complete response [CR] and 9 partial responses [PRs]) in the CN cohort (90% CI, 16.7%-42.3%) and 3 (8.8%) responses (3 PRs) in the PT cohort (90% CI, 2.5%-21.3%). Median progression-free survival was 4.5 months in the CN cohort and 4.1 months in the PT cohort. Median overall survival (OS) was 11.1 months in the CN group and 10.9 months in the PT group. Severe toxicities in both groups (Common Terminology Criteria for Adverse Effects v.3.0 ≥grade 3) included neutropenia, thrombocytopenia, neurosensory problems, fatigue, nausea, and vomiting.
  
  
  CONCLUSIONS
  The weekly combination of ABI-007 and carboplatin appears to be moderately well tolerated, with promising clinical activity as therapy in patients who are chemotherapy naive and with modest antitumor activity in those previously treated.
authors.affiliation: Mayo Clinic Rochester, Rochester, Minnesota 55905, USA. kottschade.lisa@mayo.edu
authors.forename: Lisa A
authors.initials: LA
authors.lastname: Kottschade
authors.forename: Vera J
authors.initials: VJ
authors.lastname: Suman
authors.forename: Thomas
authors.initials: T
authors.lastname: Amatruda
authors.forename: Robert R
authors.initials: RR
authors.lastname: McWilliams
authors.forename: Bassam I
authors.initials: BI
authors.lastname: Mattar
authors.forename: Daniel A
authors.initials: DA
authors.lastname: Nikcevich
authors.forename: Robert
authors.initials: R
authors.lastname: Behrens
authors.forename: Tom R
authors.initials: TR
authors.lastname: Fitch
authors.forename: Anthony J
authors.initials: AJ
authors.lastname: Jaslowski
authors.forename: Svetomir N
authors.initials: SN
authors.lastname: Markovic
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000068196:Albumin-Bound Paclitaxel; D000418:Albumins / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D016190:Carboplatin / Q000008:administration & dosage*; D015331:Cohort Studies; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008297:Male; D008545:Melanoma / Q000188:drug therapy* / Q000473:pathology; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage*; D012878:Skin Neoplasms / Q000188:drug therapy* / Q000473:pathology
chemical_list: D000068196:Albumin-Bound Paclitaxel; D000418:Albumins; D016190:Carboplatin; D017239:Paclitaxel