Bevacizumab and everolimus in the treatment of patients with metastatic melanoma: A phase 2 trial of the Sarah Cannon Oncology Research Consortium

Cancer

Volumn 116, Issue 17, 2010, Pages 4122-4129

  Hainsworth, John D ^a,b   Infante, Jeffrey R ^a,b   Spigel, David R ^a,b   Peyton, James D ^b   Thompson, Dana S ^b   Lane, Cassie M ^a   Clark, Bobby L ^a   Rubin, Mark S ^c   Trent, David F ^d   Burris III, Howard A ^a,b  

^a SARAH CANNON RESEARCH INSTITUTE   (United States)

^b PLLC   (United States)

^c Florida Cancer Specialists   (United States)

^d Virginia Cancer Institute   (United States)

Author keywords

Antiangiogenesis; Bevacizumab; Everolimus; Mammalian target of rapamycin (mTOR); Metastatic melanoma; Phase 2; Vascular endothelial growth factor

Indexed keywords

BEVACIZUMAB; EVEROLIMUS; ANTINEOPLASTIC AGENT; MONOCLONAL ANTIBODY; RAPAMYCIN;

ADULT; AGED; ANEMIA; ANTIANGIOGENIC ACTIVITY; ARTICLE; CLINICAL EVALUATION; CLINICAL TRIAL; DIARRHEA; DRUG EFFICACY; DRUG TOLERABILITY; EPISTAXIS; FATIGUE; FEMALE; FOLLOW UP; HUMAN; HYPERTENSION; MAJOR CLINICAL STUDY; MALE; MELANOMA; METASTATIC MELANOMA; MUCOSA INFLAMMATION; MULTIPLE CYCLE TREATMENT; NAUSEA; NEUTROPENIA; OVERALL SURVIVAL; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; PROTEINURIA; SKIN TOXICITY; STOMATITIS; THROMBOCYTOPENIA; TUMOR GROWTH; VOMITING; ANALOGS AND DERIVATIVES; METASTASIS; MIDDLE AGED; MORTALITY; MULTICENTER STUDY; PATHOLOGY; VERY ELDERLY;

ADULT; AGED; AGED, 80 AND OVER; ANTIBODIES, MONOCLONAL; ANTIBODIES, MONOCLONAL, HUMANIZED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; FEMALE; HUMANS; MALE; MELANOMA; MIDDLE AGED; NEOPLASM METASTASIS; SIROLIMUS;

EID: 77956839364     PISSN: 0008543X     EISSN: 10970142     Source Type: Journal    
DOI: 10.1002/cncr.25320     Document Type: Article

References (35)

1. Jemal A, Siegel R, Ward E, Murray T, Xu J, Thun MJ. Cancer statistics, 2007. CA Cancer J Clin. 2007;57:43-66.
2. Middleton MR, Grob JJ, Aaronson N, et al. Randomized phase III study of temozolomide versus dacarbazine in the treatment of patients with advanced metastatic malignant melanoma. J Clin Oncol. 2000;18:158-166.
3. Ugurel S, Rappl G, Tilgen W, Reinhold U. Increased serum concentration of angiogenic factors in malignant melanoma patients correlates with tumor progression and survival. J Clin Oncol. 2001;19:577-583.
4. Mehnert JM, McCarthy MM, Aziz SA, et al. VEGF, VEGFR1, and VEGFR2 expression in melanoma. J Clin Oncol. 2007;25:477s. Abstract 8520.
5. Mouawad R, Soubrane C, Khayat D. Prognostic relevance of pretreatment soluble vascular endothelial growth factors (A, C, D) and their receptors (R1, R2, and R3) in advanced melanoma patients. J Clin Oncol. 2007;25:482s. Abstract 8540.
6. Spano J, Mouawad R, Vignot S, Magne N, Khayat D. Role of circulating angiogenin TGF-b1, VEGF-R1, and VEGFR2 in metastatic malignant melanoma patients. J Clin Oncol. 2009;27:473s. Abstract 9048.
7. Corrie P, Kareclas P, Mann C, et al. A phase II study of PTK787 in metastatic melanoma patients. J Clin Oncol. 2008;26:494s. Abstract 9048.
8. Fruehauf JP, Lutzky J, McDermott DF, et al. Axitinib (AG-013736) in patients with metastatic melanoma: a phase II study. J Clin Oncol. 2008;26:484s. Abstract 9006.
9. Chan KR, Gundala S, Laudadio M, Mastrangelo M, Yamamoto A, Sato T. A pilot study using sunitinib malate as therapy in patients with stage IV uveal melanoma. J Clin Oncol. 2008;26:494s. Abstract 9047.
10. Boasberg P, Cruickshank S, Hamid O, O'Day S, Weber R, Spitler L. Nab-paclitaxel and bevacizumab as first-line therapy in patients with unresectable stage III and IV melanoma. J Clin Oncol. 2009;27:476s. Abstract 9061.
11. Perez DG, Suman V, Amatruda T, et al. Phase II trial of carboplatin, weekly paclitaxel, and biweekly bevacizumab in patients with unresectable stage IV melanoma. J Clin Oncol. 2007;25:487s. Abstract 8560.
12. Viteri S, Diaz-Lagares A, Gonzalez A, et al. VEGF serum levels during bevacizumab plus paclitaxel combination in metastatic melanoma. J Clin Oncol. 2007;25:480s. Abstract 8534.
13. McDermott DF, Sosman JA, Gonzalez R, et al. Double-blind randomized phase II study of the combination of sorafenib and dacarbazine in patients with advanced melanoma: a report from the 11715 Study Group. J Clin Oncol. 2008;26:2178-2185.
14. Tarhini AA, Christensen S, Frankel P, et al. Phase II study of aflibercept (VEGF trap) in recurrent inoperable stage III or stage IV melanoma of cutaneous or ocular origin. J Clin Oncol. 2009;27:468s. Abstract 9028.
15. Rowinsky EK. Targeting the molecular target of rapamycin (mTOR). Curr Opin Oncol. 2004;16:564-575.
16. Chan S. Targeting the mammalian target of rapamycin (mTOR): a new approach to treating cancer. Br J Cancer. 2004;91:1420-1424.
17. Margolin K, Longmate J, Baratta T, et al. CCI-779 in metastatic melanoma. Cancer. 2005;104:1045-1048.
18. Rao RD, Allred JB, Windschitl HE, et al. N0377: results of NCCTG phase II trial of the mTOR inhibitor RAD-001 in metastatic melanoma. J Clin Oncol. 2007;25:479s. Abstract 8530.
19. Kim KB, Davies MA, Papadopoulos NE, et al. Phase I/II study of the combination of sorafenib and temsirolimus in patients with metastatic melanoma. J Clin Oncol. 2009;27:467s. Abstract 9026.
20. Whorf RC, Hainsworth JD, Spigel DR, et al. Phase II study of bevacizumab and everolimus (RAD001) in the treatment of advanced renal cell carcinoma (RCC). J Clin Oncol. 2010;28:2131-2136.
21. Therasse P, Arbuck SG, Eisenhauer EA, et al. New guidelines to evaluate the response to treatment in solid tumors. European Organization for Research and Treatment of Cancer, National Cancer Institute of the United States, National Cancer Institute of Canada. J Natl Cancer Inst. 2000;92:205-216.
22. Kaplan EL, Meier P. Nonparametric estimation from incomplete observations. J Am Stat Assoc. 1958;53:457-481.
23. Hauschild A, Agarwala SS, Trefzer U, et al. Results of a phase III, randomized, placebo-controlled study of sorafenib in combination with carboplatin and paclitaxel as secondline treatment in patients with unresectable stage III or stage IV melanoma. J Clin Oncol. 2009;27:2823-2830.
24. Rao RD, Holtan SG, Ingle JN, et al. Combination of paclitaxel and carboplatin as second-line therapy for patients with metastatic melanoma. Cancer. 2006;106:375-382.
25. Hwu WJ, Krown SE, Menell JH, et al. Phase II study of temozolomide plus thalidomide for the treatment of metastatic melanoma. J Clin Oncol. 2003;21:3351-3356.
26. Atkins MB, Hsu J, Lee S, et al. Phase III trial comparing concurrent biochemotherapy with cisplatin, vinblastine, dacarbazine, interleukin-2, and interferon alfa-2b with cisplatin, vinblastine, and dacarbazine alone in patients with metastatic malignant melanoma (E3695): a trial coordinated by the Eastern Cooperative Oncology Group. J Clin Oncol. 2008;26:5748-5754.
27. O'Day S, Kim KB, Sosman JA, et al. BEAM: a randomized phase II study evaluating the activity of bevacizumab in combination with carboplatin plus paclitaxel in patients with previously treated advanced melanoma [abstract]. Eur J Cancer. 2009;7(suppl);13. Abstract 23LBA.
28. Fecher LA, Cummings SD, Keefe MJ, Alani RM. Toward a molecular classification of melanoma. J Clin Oncol. 2007;25:1606-1620.
29. Stahl JM, Sharma A, Cheung M, et al. Deregulated Akt3 activity promotes development of malignant melanoma. Cancer Res. 2004;64:7002-7010.
30. Stahl JM, Cheung M, Sharma A, Trivedi NR, Shanmugam S, Robertson GP. Loss of PTEN promotes tumor development in malignant melanoma. Cancer Res. 2003;63:2881-2890.
31. Halilovic E, Solit DB. Therapeutic strategies for inhibiting oncogenic BRAF signaling. Curr Opin Pharmacol. 2008;8:419-426.
32. Flaherty K, Puzanov I, Sosman J, et al. Phase I study of PLX4032: proof of concept for V600E BRAF mutation as a therapeutic target in human cancer. J Clin Oncol. 2009;27:461s. Abstract 9000.
33. Schwartz GK, Robertson S, Shen A, et al. A phase I study of XL281, a selective oral RAF kinase inhibitor, in patients (Pts) with advanced solid tumors. J Clin Oncol. 2009;27:149s. Abstract 3513.
34. Goel VK, Lazar AJ, Warneke CL, Redston MS, Haluska FG. Examination of mutations in BRAF, NRAS, and PTEN in primary cutaneous melanoma. J Invest Dermatol. 2006;126:154-160.
35. Carracedo A, Ma L, Teruya-Feldstein J, et al. Inhibition of mTORC1 leads to MAPK pathway activation through a PI3K-dependent feedback loop in human cancer. J Clin Invest. 2008;118:3065-3074.