A phase II trial of Sunitinib malate in recurrent and refractory ovarian, fallopian tube and peritoneal carcinoma

Gynecologic Oncology

Volumn 128, Issue 2, 2013, Pages 215-220

  Campos, Susana M ^a   Penson, Richard T ^b   Matulonis, Ursula ^a   Horowitz, Neil S ^c   Whalen, Christin ^a   Pereira, Lauren ^a   Tyburski, Karin ^a   Roche, Maria ^b   Szymonifka, Jackie ^b   Berlin, Suzanne ^a  

^a DANA FARBER CANCER INSTITUTE   (United States)

^b MASSACHUSETTS GENERAL HOSPITAL   (United States)

^c BRIGHAM AND WOMEN S HOSPITAL   (United States)

Author keywords

Angiogenic biomarkers; Ovarian cancer; Targeted therapy; Tyrosine kinase inhibitors

Indexed keywords

SUNITINIB;

ADULT; ARTICLE; BLEEDING; BONE MARROW SUPPRESSION; CANCER SURVIVAL; CLINICAL ARTICLE; DIGESTIVE SYSTEM PERFORATION; DRUG EFFICACY; DRUG HYPERSENSITIVITY; DRUG SAFETY; ENDOCRINE DISEASE; EYE TOXICITY; FEMALE; GASTROINTESTINAL SYMPTOM; HUMAN; HYPERTENSION; INFECTION; LUNG TOXICITY; LYMPHATIC SYSTEM DISEASE; METABOLIC DISORDER; MULTIPLE CYCLE TREATMENT; MUSCULOSKELETAL DISEASE; NEUROLOGIC DISEASE; OPEN STUDY; OVARY CARCINOMA; PAIN; PERITONEUM CANCER; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; REPRODUCTIVE TOXICITY; SKIN TOXICITY; SURVIVAL RATE; SURVIVAL TIME; TREATMENT RESPONSE; UTERINE TUBE CARCINOMA;

ADULT; AGED; ANGIOGENESIS INHIBITORS; ANTINEOPLASTIC AGENTS; DISEASE-FREE SURVIVAL; DRUG ADMINISTRATION SCHEDULE; FALLOPIAN TUBE NEOPLASMS; FEMALE; HUMANS; INDOLES; MIDDLE AGED; NEOPLASM RECURRENCE, LOCAL; OVARIAN NEOPLASMS; PERITONEAL NEOPLASMS; PROTEIN KINASE INHIBITORS; PYRROLES;

EID: 84872869916     PISSN: 00908258     EISSN: 10956859     Source Type: Journal    
DOI: 10.1016/j.ygyno.2012.07.126     Document Type: Article

References (40)

1. Ozols R. Ovarian cancer, fallopian tube carcinoma and peritoneal carcinoma V.T. Devita, Cancer, Principles and Practice of Oncology 1997 Lippincott-Raven Philadelphia, PA
2. A.N. Gordon, J.T. Fleagle, D. Guthrie, D.E. Parkin, M.E. Gore, and A.J. Lacave Recurrent epithelial ovarian carcinoma: a randomized phase III study of pegylated liposomal doxorubicin versus topotecan J Clin Oncol 19 2001 3312 3322 (Pubitemid 32642183)
3. T.A. Olson, D. Mohanraj, L.F. Carson, and S. Ramakrishnan Vascular permeability factor gene expression in normal and neoplastic human ovaries Cancer Res 54 1994 276 280 (Pubitemid 24042123)
4. D. Matei, S. Kelich, L. Cao, N. Menning, R.E. Emerson, and J. Rao PDGF BB induces VEGF secretion in ovarian cancer Cancer Biol Ther 6 2007 1951 1959 (Pubitemid 351590409)
5. D. Matei, R.E. Emerson, Y.C. Lai, L.A. Baldridge, J. Rao, and C. Yiannoutsos Autocrine activation of PDGFRalpha promotes the progression of ovarian cancer Oncogene 25 2006 2060 2069
6. R. Henriksen, K. Funa, E. Wilander, T. Backstrom, M. Ridderheim, and K. Oberg Expression and prognostic significance of platelet-derived growth factor and its receptors in epithelial ovarian neoplasms Cancer Res 53 1993 4550 4554 (Pubitemid 23304378)
7. R. Erber, A. Thurnher, A.D. Katsen, G. Groth, H. Kerger, and H.P. Hammes Combined inhibition of VEGF and PDGF signaling enforces tumor vessel regression by interfering with pericyte-mediated endothelial cell survival mechanisms FASEB J 18 2004 338 340
8. R.A. Burger, M.W. Sill, B.J. Monk, B.E. Greer, and J.I. Sorosky Phase II trial of bevacizumab in persistent or recurrent epithelial ovarian cancer or primary peritoneal cancer: a Gynecologic Oncology Group Study J Clin Oncol 25 2007 5165 5171 (Pubitemid 350237599)
9. S.A. Cannistra, U.A. Matulonis, R.T. Penson, J. Hambleton, J. Dupont, and H. Mackey Phase II study of bevacizumab in patients with platinum-resistant ovarian cancer or peritoneal serous cancer J Clin Oncol 25 2007 5180 5186 (Pubitemid 350232248)
10. A.A. Garcia, H. Hirte, G. Fleming, D. Yang, D.D. Tsao-Wei, and L. Roman Phase II clinical trial of bevacizumab and low-dose metronomic oral cyclophosphamide in recurrent ovarian cancer: a trial of the California, Chicago, and Princess Margaret Hospital phase II consortia J Clin Oncol 26 2008 76 82
11. J.D. Wright, A. Hagemann, J.S. Rader, D. Viviano, R.K. Gibb, and L. Norris Bevacizumab combination therapy in recurrent, platinum-refractory, epithelial ovarian carcinoma: a retrospective analysis Cancer 107 2006 83 89 (Pubitemid 43939034)
12. J.C. Chura, K. Van Iseghem, L.S. Downs Jr., L.F. Carson, and P.L. Judson Bevacizumab plus cyclophosphamide in heavily pretreated patients with recurrent ovarian cancer Gynecol Oncol 107 2007 326 330 (Pubitemid 47575735)
13. H.S. Nimeiri, A.M. Oza, R.J. Morgan, G. Friberg, K. Kasza, and L. Faoro Efficacy and safety of bevacizumab plus erlotinib for patients with recurrent ovarian, primary peritoneal, and fallopian tube cancer: a trial of the Chicago, PMH, and California Phase II Consortia Gynecol Oncol 110 2008 49 55
14. B.J. Monk, E. Han, C.A. Josephs-Cowan, G. Pugmire, and R.A. Burger Salvage bevacizumab (rhuMAB VEGF)-based therapy after multiple prior cytotoxic regimens in advanced refractory epithelial ovarian cancer Gynecol Oncol 102 2006 140 144 (Pubitemid 44056265)
15. R.T. Penson, D.S. Dizon, S.A. Cannistra, M.R. Roche, C.N. Krasner, and S.T. Berlin Phase II study of carboplatin, paclitaxel, and bevacizumab with maintenance bevacizumab as first-line chemotherapy for advanced Mullerian tumors J Clin Oncol 28 2010 154 159
16. R.A. Burger, M.F. Brady, M.A. Bookman, G.F. Fleming, B.J. Monk, and H. Huang Incorporation of bevacizumab in the primary treatment of ovarian cancer N Engl J Med 365 2011 2473 2483
17. T.J. Perren, A.M. Swart, J. Pfisterer, J.A. Ledermann, E. Pujade-Lauraine, and G. Kristensen A phase 3 trial of bevacizumab in ovarian cancer N Engl J Med 365 2011 2484 2496
18. S.P. Ivy, J.Y. Wick, and B.M. Kaufman An overview of small-molecule inhibitors of VEGFR signaling Nat Rev Clin Oncol 6 2009 569 579
19. U.A. Matulonis, S. Berlin, P. Ivy, K. Tyburski, C. Krasner, and C. Zarwan Cediranib, an oral inhibitor of vascular endothelial growth factor receptor kinases, is an active drug in recurrent epithelial ovarian, fallopian tube, and peritoneal cancer J Clin Oncol 27 2009 5601 5606
20. M. Friedlander, K.C. Hancock, D. Rischin, M.J. Messing, C.A. Stringer, and G.M. Matthys A Phase II, open-label study evaluating pazopanib in patients with recurrent ovarian cancer Gynecol Oncol 119 2010 32 37
21. D. Matei, M.W. Sill, H.A. Lankes, K. DeGeest, R.E. Bristow, and D. Mutch Activity of sorafenib in recurrent ovarian cancer and primary peritoneal carcinomatosis: a Gynecologic Oncology Group trial J Clin Oncol 29 2011 69 75
22. L. Bodnar, M. Gornas, and C. Szczylik Sorafenib as a third line therapy in patients with epithelial ovarian cancer or primary peritoneal cancer: a phase II study Gynecol Oncol 123 2011 33 36
23. J.A. Ledermann, A. Hackshaw, S. Kaye, G. Jayson, H. Gabra, and I. McNeish Randomized phase II placebo-controlled trial of maintenance therapy using the oral triple angiokinase inhibitor BIBF 1120 after chemotherapy for relapsed ovarian cancer J Clin Oncol 29 2011 3798 3804
24. R.A. Burger Overview of anti-angiogenic agents in development for ovarian cancer Gynecol Oncol 121 2011 230 238
25. D.B. Mendel, A.D. Laird, X. Xin, S.G. Louie, J.G. Christensen, and G. Li In vivo antitumor activity of SU11248, a novel tyrosine kinase inhibitor targeting vascular endothelial growth factor and platelet-derived growth factor receptors: determination of a pharmacokinetic/pharmacodynamic relationship Clin Cancer Res 9 2003 327 337 (Pubitemid 36109749)
26. R.J. Motzer, M.D. Michaelson, B.G. Redman, G.R. Hudes, G. Wilding, and R.A. Figlin Activity of SU11248, a multitargeted inhibitor of vascular endothelial growth factor receptor and platelet-derived growth factor receptor, in patients with metastatic renal cell carcinoma J Clin Oncol 24 2006 16 24 (Pubitemid 46630489)
27. V.L. Goodman, E.P. Rock, R. Dagher, R.P. Ramchandani, S. Abraham, and J.V. Gobburu Approval summary: sunitinib for the treatment of imatinib refractory or intolerant gastrointestinal stromal tumors and advanced renal cell carcinoma Clin Cancer Res 13 2007 1367 1373 (Pubitemid 46450424)
28. H.J. Burstein, A.D. Elias, H.S. Rugo, M.A. Cobleigh, A.C. Wolff, and P.D. Eisenberg Phase II study of sunitinib malate, an oral multitargeted tyrosine kinase inhibitor, in patients with metastatic breast cancer previously treated with an anthracycline and a taxane J Clin Oncol 26 2008 1810 1816
29. E. Raymond, L. Dahan, J.L. Raoul, Y.J. Bang, I. Borbath, and C. Lombard-Bohas Sunitinib malate for the treatment of pancreatic neuroendocrine tumors New England Journal of Medicine 364 2011 501 513
30. J.J. Biagi, A.M. Oza, H.I. Chalchal, R. Grimshaw, S.L. Ellard, and U. Lee A phase II study of sunitinib in patients with recurrent epithelial ovarian and primary peritoneal carcinoma: an NCIC Clinical Trials Group Study Ann Oncol 22 2011 335 340
31. S. George, J.Y. Blay, P.G. Casali, A. Le Cesne, P. Stephenson, and S.E. Deprimo Clinical evaluation of continuous daily dosing of sunitinib malate in patients with advanced gastrointestinal stromal tumour after imatinib failure Eur J Cancer 45 2009 1959 1968
32. K.H. Baumann, A. du Bois, W. Meier, J. Rau, P. Wimberger, and J. Sehouli A phase II trial (AGO 2.11) in platinum-resistant ovarian cancer: a randomized multicenter trial with sunitinib (SU11248) to evaluate dosage, schedule, tolerability, toxicity and effectiveness of a multitargeted receptor tyrosine kinase inhibitor monotherapy Ann Oncol. Feb 29 2012
33. F. Girardi, E. Franceschi, and A.A. Brandes Cardiovascular safety of VEGF-targeting therapies: current evidence and handling strategies Oncologist 15 2010 683 694
34. J.R. Dyck, and G.D. Lopaschuk AMPK alterations in cardiac physiology and pathology: enemy or ally? J Physiol 574 2006 95 112 (Pubitemid 43905800)
35. K. Terai, Y. Hiramoto, M. Masaki, S. Sugiyama, T. Kuroda, and M. Hori AMP-activated protein kinase protects cardiomyocytes against hypoxic injury through attenuation of endoplasmic reticulum stress Mol Cell Biol 25 2005 9554 9575 (Pubitemid 41507855)
36. V. Ranpura, S. Hapani, J. Chuang, and S. Wu Risk of cardiac ischemia and arterial thromboembolic events with the angiogenesis inhibitor bevacizumab in cancer patients: a meta-analysis of randomized controlled trials Acta Oncol 49 2010 287 297
37. C Aghajanian, SV Blank, BA Goff, PL Judson, MG Teneriello, and A Husain OCEANS: a randomized, double-blind, placebo-controlled phase III trial of chemotherapy with or without bevacizumab in patients with platinum-sensitive recurrent epithelial ovarian, primary peritoneal, or fallopian tube cancer J Clin Oncol 29 2011 [(18 s, part II of II):781 s (LBA 5007)]
38. N. Murukesh, C. Dive, and G.C. Jayson Biomarkers of angiogenesis and their role in the development of VEGF inhibitors Br J Cancer 102 2010 8 18
39. B.P. Schneider, M. Wang, M. Radovich, G.W. Sledge, S. Badve, and A. Thor Association of vascular endothelial growth factor and vascular endothelial growth factor receptor-2 genetic polymorphisms with outcome in a trial of paclitaxel compared with paclitaxel plus bevacizumab in advanced breast cancer: ECOG 2100 J Clin Oncol 26 2008 4672 4678
40. A.M. Schultheis, G. Lurje, K.E. Rhodes, W. Zhang, D. Yang, and A.A. Garcia Polymorphisms and clinical outcome in recurrent ovarian cancer treated with cyclophosphamide and bevacizumab Clin Cancer Res 14 2008 7554 7563