A phase 2 randomised study of ramucirumab (IMC-1121B) with or without dacarbazine in patients with metastatic melanoma

European Journal of Cancer

Volumn 50, Issue 12, 2014, Pages 2099-2107

  Carvajal, Richard D ^a   Wong, Michael K ^b   Thompson, John A ^c   Gordon, Michael S ^d   Lewis, Karl D ^e   Pavlick, Anna C ^f   Wolchok, Jedd D ^a   Rojas, Patrick B ^g   Schwartz, Jonathan D ^g   Bedikian, Agop Y ^h  

^a MEMORIAL SLOAN KETTERING CANCER CENTER   (United States)

^b UNIVERSITY OF SOUTHERN CALIFORNIA   (United States)

^c SEATTLE CANCER CARE ALLIANCE   (United States)

^d Pinnacle Oncology Hematology   (United States)

^e UNIVERSITY OF COLORADO   (United States)

^f NEW YORK UNIVERSITY   (United States)

^g ELI LILLY AND COMPANY   (United States)

^h UNIVERSITY OF TEXAS MD ANDERSON CANCER CENTER   (United States)

Author keywords

Metastatic melanoma; Phase II; Ramucirumab

Indexed keywords

DACARBAZINE; HISTAMINE H1 RECEPTOR ANTAGONIST; RAMUCIRUMAB;

ACUTE KIDNEY FAILURE; ADULT; AGED; ARTICLE; BACKACHE; BRAIN HEMORRHAGE; BRONCHOSPASM; CANCER COMBINATION CHEMOTHERAPY; CANCER SURVIVAL; CHILL; CONTROLLED STUDY; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG FATALITY; DRUG INDUCED HEADACHE; DRUG SAFETY; EPISTAXIS; FAINTNESS; FATIGUE; FEBRILE; FEBRILE NEUTROPENIA; FEMALE; FLUSHING; HEART ARREST; HUMAN; HYPERTENSION; HYPOTENSION; HYPOXIA; INFUSION RELATED REACTION; LIVER FAILURE; MAJOR CLINICAL STUDY; MALE; METASTATIC MELANOMA; MONOTHERAPY; NEUTROPENIA; OPEN STUDY; OUTCOME ASSESSMENT; OVERALL SURVIVAL; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; PROCTALGIA; PROGRESSION FREE SURVIVAL; PROTEINURIA; PRURITUS; RANDOMIZED CONTROLLED TRIAL; RIGOR; SIDE EFFECT; SUPRAVENTRICULAR TACHYCARDIA; TACHYCARDIA; THROMBOCYTOPENIA; TREATMENT RESPONSE; TUMOR BLEEDING; VEIN THROMBOSIS;

METASTATIC MELANOMA; PHASE II; RAMUCIRUMAB;

ADULT; AGED; AGED, 80 AND OVER; ANTIBODIES, MONOCLONAL; ANTINEOPLASTIC AGENTS; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; DACARBAZINE; FEMALE; HUMANS; MALE; MELANOMA; MIDDLE AGED; SKIN NEOPLASMS; SURVIVAL ANALYSIS; YOUNG ADULT;

EID: 84904049824     PISSN: 09598049     EISSN: 18790852     Source Type: Journal    
DOI: 10.1016/j.ejca.2014.03.289     Document Type: Article

References (25)

1. American Cancer Society. Cancer facts & figures 2012. Atlanta, GA: American Cancer Society. http://www.cancer.org/research/cancerfactsfigures/ cancerfactsfigures/cancer-facts-figures-2012; 2012 [accessed August 28, 2013].
2. L. Finn, S.N. Markovic, and R.W. Joseph Therapy for metastatic melanoma: the past, present, and future BMC Med 10 2012 23 32
3. E. Rofstad, and E. Halsor Vascular endothelial growth factor, interleukin 8, platelet-derived endothelial cell growth factor, and basic fibroblastic growth factor promote angiogenesis and metastasis in human melanoma xenografts Cancer Res 60 2000 4932 4938
4. D. Lu, J. Shen, and M.D. Vil et al. Tailoring in vitro selection for a picomolar affinity human antibody directed against vascular endothelial growth factor receptor 2 for enhanced neutralizing activity J Biol Chem 278 2003 43496 43507
5. P. Redondo, I. Sánchez-Carpintero, A. Bauzá, M. Idoate, T. Solano, and M.C. Mihm Jr. Immunologic escape and angiogenesis in human malignant melanoma J Am Acad Dermatol 49 2003 255 263
6. P.A. Ascierto, E. Leonardi, A. Ottaiano, M. Napolitano, S. Scala, and G. Castello Prognostic value of serum VEGF in melanoma patients: a pilot study Anticancer Res 24 2004 4255 4258
7. C. Demirkesen, N. Büyükpinarbasili, R. Ramazanoǧlu, O. Oǧuz, N.M. Mandel, and G. Kaner The correlation of angiogenesis with metastasis in primary cutaneous melanoma: a comparative analysis of microvessel density, expression of vascular endothelial growth factor and basic fibroblastic growth factor Pathology 38 2006 132 137
8. F. Tas, D. Duranyildiz, H. Oǧuz, H. Camlica, V. Yasasever, and E. Topuz Circulating serum levels of angiogenic factors and vascular endothelia growth factor receptors 1 and 2 in melanoma patients Melanoma Res 16 2006 405 411
9. D.I. Gabrilovich, H.L. Chen, and K.R. Girgis et al. Production of vascular endothelial growth factor by human tumors inhibits the function maturation of dendritic cells Nat Med 2 1996 1096 1103
10. T. Oyama, S. Ran, and T. Ishida et al. Vascular endothelial growth factor affects dendritic cell maturation through the inhibition of nuclear factor kappa B activation in hemopoietic progenitor cells J Immunol 160 1998 1224 1232
11. K.B. Kim, J.A. Sosman, and J.P. Fruehauf et al. BEAM: a randomized phase II study evaluating the activity of bevacizumab in combination with carboplatin plus paclitaxel in patients with previously untreated advanced melanoma J Clin Oncol 30 2012 34 41
12. M. Prewett, J. Huber, and Y. Li et al. Antivascular endothelial growth factor receptor (fetal liver kinase 1) monoclonal antibody inhibits tumor angiogenesis and growth of several mouse and human tumors Cancer Res 59 1999 5209 5218
13. J.L. Spratlin, R.B. Cohen, and M. Eadens et al. Phase I pharmacologic and biologic study of ramucirumab (IMC-1121B), a fully human immunoglobulin G1 monoclonal antibody targeting the vascular endothelial growth factor receptor- 2 J Clin Oncol 28 2010 780 787
14. Chiorean E, Sweeney C, Hurwitz H, et al. Phase I dose-escalation study of the anti-VEGF-2 recombinant human IgG1 monoclonal antibody IMC-1121B, administered every other week or every 3 weeks in patients with advanced cancers. Molecular targets and cancer therapeutics. In: 19th annual AACR-NCI-EORTC conference, October 22-26, 2007, San Francisco, California, USA [abstract # B15].
15. M.R. Middleton, J.J. Grob, and N. Aaronson et al. Randomized phase III study of temozolomide versus dacarbazine in the treatment of patients with advanced metastatic malignant melanoma J Clin Oncol 18 2000 158 166
16. D.C. Lev, A. Onn, and V.O. Melinkova et al. Exposure of melanoma cells to dacarbazine results in enhanced tumor growth and metastasis in vivo J Clin Oncol 22 2004 2092 2100
17. D.C. Lev, M. Ruiz, L. Mills, E.C. McGary, J.E. Price, and M. Bar-Eli Dacarbazine causes transcriptional up-regulation of interleukin 8 and vascular endothelial growth factor in melanoma cells: a possible escape mechanism from chemotherapy Mol Cancer Ther 2 2003 753 763
18. American Joint Committee on Cancer 2002. AJCC Cancer Staging Manual (6th ed.): Melanoma of the Skin. http://www.cancerstaging.org/products/csmanual6ed-3. pdf. p. 209-17 [accessed August 28, 2013].
19. P. Therasse, S.G. Arbuck, and E.A. Eisenhauer 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 3 2000 205 216
20. J.R. Anderson, K.C. Cain, and R.D. Gelber Analysis of survival by tumor response and other comparisons of time-to-event by outcome variables J Clin Oncol 26 2008 3913 3915
21. A.M.M. Eggermont, and J.M. Kirkwood Re-evaluating the role of dacarbazine in metastatic melanoma: what have we learned in 30 years? Eur J Cancer 40 2004 1825 1836
22. A.Y. Bedikian, M. Millward, and H. Pehamberger et al. Bcl-2 antisense (oblimersen sodium) plus dacarbazine in patients with advanced melanoma: the Oblimersen Melanoma Study Group J Clin Oncol 24 2006 4738 4745
23. M.F. Avril, S. Aamdal, and J.J. Grob et al. Fotemustine compared with dacarbazine in patients with disseminated malignant melanoma: a phase III study J Clin Oncol 22 2004 1118 1125
24. E.L. Korn, P.Y. Liu, and S.J. Lee et al. Meta-analysis of phase II cooperative group trials in metastatic stage IV melanoma to determine progression-free and overall survival benchmarks for future phase II trials J Clin Oncol 28 2008 527 534
25. Y. Huang, J. Yuan, and E. Righi et al. Vascular normalizing doses of antiangiogenic treatment reprogram the immunosuppressive tumor microenvironment and enhance immunotherapy Proc Natl Acad Sci U S A 109 2012 17561 17566