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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, N057E1
Version of Record online: 8 NOV 2010
Copyright © 2010 American Cancer Society
Volume 117, Issue 8, pages 1704–1710, 15 April 2011
How to Cite
Kottschade, L. A., Suman, V. J., Amatruda, T., McWilliams, R. R., Mattar, B. I., Nikcevich, D. A., Behrens, R., Fitch, T. R., Jaslowski, A. J. and Markovic, S. N. (2011), A phase II trial of nab-paclitaxel (ABI-007) and carboplatin in patients with unresectable stage IV melanoma. Cancer, 117: 1704–1710. doi: 10.1002/cncr.25659
Additional participants: Carle Cancer Center CCOP, Urbana, Illinois (Kendrith M. Rowland, Jr., MD); Cedar Rapids Oncology Project CCOP, Cedar Rapids, Iowa (Martin Wiesenfeld, MD); Meritcare Hospital CCOP, Fargo, North Dakota (Preston D. Steen, MD); Michigan Cancer Research Consortium, Ann Arbor, Michigan (Philip J. Stella, MD); Rapid City Regional Oncology Group, Rapid City, South Dakota (Richard C. Tenglin, MD); CentraCare Clinic, St. Cloud, Minnesota (Donald Jurgens, MD); Siouxland Hematology-Oncology Associates, Sioux City, Iowa (Donald B. Wender, MD); Toledo Community Hospital Oncology Program CCOP, Toledo, Ohio (Paul L. Schaefer, MD); Upstate Carolina CCOP, Spartanburg, South Carolina (James D. Bearden, III, MD); Missouri Valley Cancer Consortium, Omaha, Nebraska (Gamini S. Soori, MD); Cancer Care Associates, Tulsa, Oklahoma (Allan Keller, MD); Montana Cancer Consortium, Billings, Montana 59101 (Benjamin T. Marchello, MD); Illinois Oncology Research Association, Peoria, Illinois (John W. Kugler, MD); Hematology & Oncology of Dayton, Inc., Dayton, Ohio (Howard M. Gross, MD); Medcenter One Health Systems, Bismarck, North Dakota (Edward J. Wos, MD); Mayo Clinic Florida, Jacksonville, Florida (Edith A. Perez, MD); Lehigh Valley Hospital, Allentown, Pennsylvania (Suresh Nair, MD).
The content is solely the responsibility of the authors and does not necessarily represent the views of the National Cancer Institute or the National Institutes of Health.
- Issue online: 6 APR 2011
- Version of Record online: 8 NOV 2010
- Manuscript Accepted: 18 AUG 2010
- Manuscript Revised: 17 AUG 2010
- Manuscript Received: 13 MAY 2010
- metastatic melanoma;
- stage IV;
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.
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/m2) 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).
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.
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. Cancer 2011. © 2010 American Cancer Society.