Phase II evaluation of dalantercept, a soluble recombinant activin receptor-like kinase 1 (ALK1) receptor fusion protein, for the treatment of recurrent or persistent endometrial cancer: An NRG Oncology/Gynecologic Oncology Group Study 0229N

Gynecologic Oncology

Volumn 138, Issue 1, 2015, Pages 24-29

  Makker, Vicky ^a   Filiaci, Virginia L ^b   Chen, Lee May ^c   Darus, Christopher J ^d   Kendrick, James E ^e   Sutton, Gregory ^f   Moxley, Katherine ^g   Aghajanian, Carol ^a  

^a MEMORIAL SLOAN KETTERING CANCER CENTER   (United States)

^b ROSWELL PARK CANCER INSTITUTE   (United States)

^c UNIVERSITY OF CALIFORNIA   (United States)

^d MAINE MEDICAL CENTER   (United States)

^e FLORIDA HOSPITAL CANCER INSTITUTE   (United States)

^f Gynecologic Oncology St Vincent Hospitals and Health Services   (United States)

^g UNIVERSITY OF OKLAHOMA COLLEGE OF MEDICINE   (United States)

Author keywords

ALK 1; Dalantercept; Recurrent endometrial cancer

Indexed keywords

ALKALINE PHOSPHATASE; CARBOPLATIN; CREATININE; DALANTERCEPT; TAXANE DERIVATIVE; ACTIVIN RECEPTOR 2; ALK1-FC FUSION PROTEIN, HUMAN; HYBRID PROTEIN; IMMUNOGLOBULIN FC FRAGMENT;

ABDOMINAL DISTENSION; ABDOMINAL PAIN; ADULT; AGED; ALKALINE PHOSPHATASE BLOOD LEVEL; ANOREXIA; ARTHRALGIA; ARTICLE; ASCITES; BACKACHE; CANCER CHEMOTHERAPY; CANCER FATIGUE; CANCER GROWTH; CANCER PATIENT; CANCER RADIOTHERAPY; CANCER RECURRENCE; CANCER SURVIVAL; CHEMOTHERAPY INDUCED ANEMIA; CHEMOTHERAPY INDUCED EMESIS; CLINICAL ARTICLE; CONSTIPATION; CREATININE BLOOD LEVEL; DEHYDRATION; DIARRHEA; DISEASE ASSESSMENT; DIZZINESS; DRUG INDUCED HEADACHE; DRUG WITHDRAWAL; DYSPNEA; ENDOMETRIUM CARCINOMA; EPISTAXIS; FACE EDEMA; FEMALE; HUMAN; HYPERGLYCEMIA; HYPERTENSION; HYPOALBUMINEMIA; HYPOGLYCEMIA; HYPOKALEMIA; INFECTION; LYMPHOCYTE COUNT; LYMPHOCYTOPENIA; MIDDLE AGED; MULTIPLE CYCLE TREATMENT; MYALGIA; NAUSEA; NEURALGIA; OVERALL SURVIVAL; PARTIAL THROMBOPLASTIN TIME; PATIENT HISTORY OF CHEMOTHERAPY; PERIPHERAL EDEMA; PHASE 2 CLINICAL TRIAL; PLEURA EFFUSION; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; RECTUM FISTULA; RECTUM HEMORRHAGE; SIDE EFFECT; STOMACH HEMORRHAGE; THROMBOEMBOLISM; URINARY TRACT OBSTRUCTION; WEIGHT REDUCTION; CLINICAL TRIAL; DISEASE FREE SURVIVAL; ENDOMETRIAL NEOPLASMS; NEOPLASM RECURRENCE, LOCAL; NEOVASCULARIZATION, PATHOLOGIC; PATHOLOGY; TUMOR RECURRENCE; VASCULARIZATION;

ACTIVIN RECEPTORS, TYPE II; ADULT; AGED; DISEASE-FREE SURVIVAL; ENDOMETRIAL NEOPLASMS; FEMALE; HUMANS; IMMUNOGLOBULIN FC FRAGMENTS; MIDDLE AGED; NEOPLASM RECURRENCE, LOCAL; NEOVASCULARIZATION, PATHOLOGIC; RECOMBINANT FUSION PROTEINS;

EID: 84931562283     PISSN: 00908258     EISSN: 10956859     Source Type: Journal    
DOI: 10.1016/j.ygyno.2015.04.006     Document Type: Article

References (36)

1. R. Siegel, J. Ma, Z. Zou, and A. Jemal Cancer statistics, 2014 CA Cancer J. Clin. 64 2014 9 29
2. D. Miller, V. Filiaci, G. Fleming, R. Mannel, D. Cohn, and T. Matsumoto Randomized phase III noninferiority trial of first line chemotherapy for metastatic or recurrent endometrial carcinoma: a Gynecologic Oncology Group study Gynecol. Oncol. 125 2012 771 (abst)
3. F.M. Muggia, J.A. Blessing, J. Sorosky, and G.C. Reid Phase II trial of the pegylated liposomal doxorubicin in previously treated metastatic endometrial cancer: a Gynecologic Oncology Group study J. Clin. Oncol. 20 2002 2360 2364
4. D.S. Miller, J.A. Blessing, S.S. Lentz, and S.E. Waggoner A phase II trial of topotecan in patients with advanced, persistent, or recurrent endometrial carcinoma: a gynecologic oncology group study Gynecol. Oncol. 87 2002 247 251
5. A.A. Garcia, J.A. Blessing, S. Nolte, and R.S. Mannel A phase II evaluation of weekly docetaxel in the treatment of recurrent or persistent endometrial carcinoma: a study by the Gynecologic Oncology Group Gynecol. Oncol. 111 2008 22 26
6. D.S. Dizon, J.A. Blessing, D.S. McMeekin, S.K. Sharma, P. Disilvestro, and R.D. Alvarez Phase II trial of ixabepilone as second-line treatment in advanced endometrial cancer: gynecologic oncology group trial 129-P J. Clin. Oncol. 27 2009 3104 3108
7. D.S. Miller, J.A. Blessing, R.D. Drake, R. Higgins, D.S. McMeekin, and L.V. Puneky A phase II evaluation of pemetrexed (Alimta, LY231514, IND #40061) in the treatment of recurrent or persistent endometrial carcinoma: a phase II study of the Gynecologic Oncology Gynecol. Oncol. 115 2009 443 446
8. D.L. Tait, J.A. Blessing, J.S. Hoffman, K.N. Moore, N.M. Spirtos, and J.A. Lachance A phase II study of gemcitabine (Gemzar, LY188011) in the treatment of recurrent or persistent endometrial carcinoma: a gynecologic oncology group study Gynecol. Oncol. 121 2011 118 121
9. S. Lincoln, J.A. Blessing, R.B. Lee, and T.F. Rocereto Activity of paclitaxel as second-line chemotherapy in endometrial carcinoma: a gynecologic oncology group study Gynecol. Oncol. 88 2003 277 281
10. D.S. McMeekin, M.W. Sill, D. Benbrook, K.M. Darcy, D.J. Stearns-Kurosawa, and L. Eaton A phase II trial of thalidomide in patients with refractory endometrial cancer and correlation with angiogenesis biomarkers: a Gynecologic Oncology Group study Gynecol. Oncol. 105 2007 508 516
11. K.K. Leslie, M.W. Sill, E. Fischer, K.M. Darcy, R.S. Mannel, and K.S. Tewari A phase II evaluation of gefitinib in the treatment of persistent or recurrent endometrial cancer: a Gynecologic Oncology Group study Gynecol. Oncol. 129 2013 486 494
12. K.K. Leslie, M.W. Sill, H.A. Lankes, E.G. Fischer, A.K. Godwin, and H. Gray Lapatinib and potential prognostic value of EGFR mutations in a Gynecologic Oncology Group phase II trial of persistent or recurrent endometrial cancer Gynecol. Oncol. 127 2012 345 350
13. C. Aghajanian, M.W. Sill, K. Darcy, B. Greer, D.S. McMeekin, and P.G. Rose A phase II evaluation of bevacizumab in the treatment of recurrent or persistent endometrial cancer: a Gynecologic Oncology Group (GOG) study J. Clin. Oncol. 29 2011 2259 2265
14. R.L. Coleman, M.W. Sill, H.A. Lankes, A.N. Fader, N.J. Finkler, and J.S. Hoffman A phase II evaluation of aflibercept in the treatment of recurrent or persistent endometrial cancer: a Gynecologic Oncology Group study Gynecol. Oncol. 127 2012 538 543
15. E.A. Alvarez, W.E. Brady, J.L. Walker, J. Rotmensch, X.C. Zhou, and J.E. Kendrick Phase II trial of combination bevacizumab and temsirolimus in the treatment of recurrent or persistent endometrial carcinoma: a Gynecologic Oncology Group study Gynecol. Oncol. 129 2013 22 27
16. R.L. Coleman, M.W. Sill, P. Thaker, D.P. Bender, K. DeGeest, and D. Street A phase II evaluation of AZD6244, a selective MEK-1/2 inhibitor in the treatment of recurrent or persistent endometrial cancer: a Gynecologic Oncology Group Study Gynecol. Oncol. 2013 (SGO Abstract Supplement: S14; SGO#27)
17. M.A. Powell, M.W. Sill, P.J. Goodfellow, D.M. Benbrook, H.A. Lankes, and K.K. Leslie A phase II trial of brivanib in recurrent or persistent endometrial carcinoma: an NRG Oncology/Gynecologic Oncology Group Study Gynecol. Oncol. 135 2014 38 43
18. D.S. Dizon, M. Sill, J.M. Schilder, K.F. McGonigle, Z. Rhaman, and D.S. Miller Results of 229 K: a phase II trial of BIBF-1120 for women with advanced, recurrent, or metastatic endometrial carcinoma: a Gynecologic Oncology Group study Gynecol. Oncol. 133 2014 55 (SGO#133)
19. H. Chen, S. Shi, L. Acosta, W. Li, J. Lu, and S. Bao BMP10 is essential for maintaining cardiac growth during murine cardiogenesis Development 131 2004 2219 2231
20. S.P. Oh, T. Seki, K.A. Goss, T. Imamura, Y. Yi, and P.K. Donahoe Activin receptor-like kinase 1 modulates transforming growth factor-b1 signaling in the regulation of angiogenesis Proc. Natl. Acad. Sci. 97 2000 2626 2631
21. Y. Shi, and J. Massagué Mechanisms of TGF-beta signaling from cell membrane to the nucleus Cell 113 2003 685 700
22. S.I. Cunha, and K. Pietras ALK1 as an emerging target for antiangiogenic therapy of cancer Blood 117 2011 6999 7006
23. E. Cerami, J. Gao, U. Dogrusoz, B.E. Gross, S.O. Sumer, and B.A. Aksoy The cBio cancer genomics portal: an open platform for exploring multidimensional cancer genomics data Cancer Discov. 2 2012 401 404
24. J.C. Bendell, M.S. Gordon, H.I. Hurwitz, S.F. Jones, D.S. Mendelson, and G.C. Blobe Safety, pharmacokinetics, pharmacodynamics, and antitumor activity of dalantercept, an activin receptor-like kinase-1 ligand trap, in patients with advanced cancer Clin. Cancer Res. 20 2014 480 489
25. K. Brusselmans, F. Bono, D. Collen, J.M. Herbert, P. Carmeliet, and M. Dewerchin A novel role for vascular endothelial growth factor as an autocrine survival factor for embryonic stem cells during hypoxia J. Biol. Chem. 280 2005 3493 3499
26. M. Furuya, M. Nishiyama, Y. Kasuya, S. Kimura, and H. Ishikura Pathophysiology of tumor neovascularization Vasc. Health Risk Manag. 1 2005 277 290
27. M.W. Sill, L. Rubinstein, S. Litwin, and G. Yothers A method for utilizing co-primary efficacy outcome measures to screen regimens for activity in two-stage Phase II clinical trials Clin. Trials 9 2012 385 395
28. C.J. Clopper, and E.S. Pearson The use of confidence or fiducial limits illustrated in the case of the binomial Biometrika 26 1934 404 413
29. R. Brookmeyer, and J. Crowley A confidence interval for the median survival time Biometrics 38 1982 29 41
30. D. Hanahan, and R.A. Weinberg Hallmarks of cancer: the next generation Cell 144 2011 646 674
31. A. Talvensaari-Mattila, Y. Soini, and M. Santala VEGF and its receptors (flt-1 and KDR/flk-1) as prognostic indicators in endometrial carcinoma Tumour Biol. 26 2005 81 87
32. M. Saito, Y. Sato, J. Watanabe, H. Kuramoto, K. Sadayuki, and T. Fukuda Angiogenic factors in normal endometrium and endometrial adenocarcinoma Pathol. Int. 57 2007 140 147
33. Y. Yokoyama, D.S. Charnock-Jones, D. Licence, A. Yanaihara, J.M. Hastings, and C.M. Holland Expression of vascular endothelial growth factor (VEGF)-D and its receptor, VEGF receptor 3, as a prognostic factor in endometrial carcinoma Clin. Cancer Res. 9 2003 1361 1369
34. A. Giatromanolaki, E. Sivridis, R. Brekken, P.E. Thorpe, P. Anastasiadis, and K.C. Gatter The angiogenic "vascular endothelial growth factor/flk-1(KDR) receptor" pathway in patients with endometrial carcinoma: prognostic and therapeutic implications Cancer 92 2001 2569 2577
35. M. Hirai, A. Nakagawara, T. Oosaki, Y. Hayashi, M. Hirono, and T. Yoshihara Expression of vascular endothelial growth factors (VEGF-A/VEGF-1 and VEGF-C/VEGF-2) in postmenopausal uterine endometrial carcinoma Gynecol. Oncol. 80 2001 181 188
36. A. Giatromanolaki, M.I. Koukourakis, H. Turley, E. Sivridis, A.L. Harris, and K.C. Gatter Tumour and Angiogenesis Research Group. Phosphorylated KDR expression in endometrial cancer cells relates to HIF1alpha/VEGF pathway and unfavorable prognosis Mod. Pathol. 19 2006 701 707