Roscoe F. Morton owns shares of stock in Genentech.
Phase 2 trial of carboplatin, weekly paclitaxel, and biweekly bevacizumab in patients with unresectable stage IV melanoma†
A North Central Cancer Treatment Group study, N047A
Article first published online: 17 DEC 2008
Copyright © 2008 American Cancer Society
Volume 115, Issue 1, pages 119–127, 1 January 2009
How to Cite
Perez, D. G., Suman, V. J., Fitch, T. R., Amatruda, T., Morton, R. F., Jilani, S. Z., Constantinou, C. L., Egner, J. R., Kottschade, L. A. and Markovic, S. N. (2009), Phase 2 trial of carboplatin, weekly paclitaxel, and biweekly bevacizumab in patients with unresectable stage IV melanoma. Cancer, 115: 119–127. doi: 10.1002/cncr.23987
Additional participating institutions included: Wichita Community Clinical Oncology Program, Wichita, Kansas; Sioux Community Cancer Consortium, Sioux Falls, South Dakota; Missouri Valley Cancer Consortium, Omaha, Nebraska; Mayo Clinic Jacksonville, Jacksonville, Florida.
- Issue published online: 29 DEC 2008
- Article first published online: 17 DEC 2008
- Manuscript Accepted: 4 AUG 2008
- Manuscript Revised: 29 JUL 2008
- Manuscript Received: 3 APR 2008
- Public Health Service. Grant Numbers: CA-25224, CA-35267, CA-60276, CA-35101, CA-35090, CA-52352, CA-35195, CA-35269, CA-35431, CA-35103, CA-63849
- metastatic melanoma;
- phase 2 trials
BACKGROUND: Vascular endothelial growth factor (VEGF) plays an important role in the growth and metastatic progression of melanoma. Exposure of melanoma cells to chemotherapy induces VEGF overproduction, which in turn may allow melanoma cells to evade cell death and become chemotherapy resistant. Therefore, in patients with metastatic melanoma, the combination of chemotherapy with an agent that specifically targets VEGF might be able to control tumor growth and progression more effectively than chemotherapy alone. METHODS: A 2-stage phase 2 clinical trial was conducted in patients with unresectable stage IV (metastatic) melanoma to assess antitumor activity and the toxicity profile of the combination of carboplatin (area under the curve 6 iv on Day 1 of a 28-day cycle), paclitaxel (80 mg/m2 iv on Days 1, 8, and 15), and bevacizumab (10 mg/kg iv on Days 1 and 15). Treatment was continued until progression or intolerable toxicity. RESULTS: Fifty-three patients (62.3% male) were enrolled. Nine (17%) patients achieved partial remission, and another 30 (57%) achieved stable disease for at least 8 weeks. Median progression-free survival and median overall survival were 6 months and 12 months, respectively. One patient died after 8 treatment cycles from intracranial hemorrhage into undiagnosed brain metastases. The most common severe (grade ≥3) toxicities were neutropenia (53%), thrombocytopenia (11%), hypertension (9%), and anemia (8%). CONCLUSIONS: This combination of carboplatin, paclitaxel, and bevacizumab appears to be moderately well tolerated and clinically beneficial in patients with metastatic melanoma. Further study of this combination is warranted. Cancer 2009. © 2008 American Cancer Society.