An open-label, phase 2 study evaluating the efficacy and safety of the anti-IGF-1R antibody cixutumumab in patients with previously treated advanced or metastatic soft-tissue sarcoma or Ewing family of tumours

European Journal of Cancer

Volumn 49, Issue 15, 2013, Pages 3219-3228

  Schoffski P ^a   Adkins, D ^b   Blay, J Y ^c   Gil, T ^d   Elias, A D ^e   Rutkowski, P ^f   Pennock, G K ^g   Youssoufian, H ^h   Gelderblom, H ⁱ   Willey, R ^j,k   Grebennik, D O ^j,l  

^a UNIVERSITY HOSPITALS LEUVEN   (Belgium)

^b WASHINGTON UNIVERSITY SCHOOL OF MEDICINE   (United States)

^c UNIVERSITÉ LYON 1   (France)

^d JULES BORDET INSTITUTE   (Belgium)

^e UNIVERSITY OF COLORADO SCHOOL OF MEDICINE   (United States)

^f INSTITUTE OF ONCOLOGY   (Poland)

^g M D ANDERSON CANCER CENTER ORLANDO   (United States)

^h Ziopharm Oncology Inc   (United States)

ⁱ LEIDEN UNIVERSITY MEDICAL CENTER   (Netherlands)

^j ELI LILLY AND COMPANY   (United States)

^k EISAI INC   (United States)

^l KYOWA HAKKO KOGYO CO LTD   (Japan)

more..

Author keywords

Adipocytic sarcoma; Cixutumumab; Ewing family of tumours; Insulin like growth factor receptor; Leiomyosarcoma; Rhabdomyosarcoma; Soft tissue sarcoma; Synovial sarcoma

Indexed keywords

BRIVANIB; CIXUTUMUMAB; DACARBAZINE; DOCETAXEL; DOXORUBICIN; EPIRUBICIN; GEMCITABINE; IFOSFAMIDE; MESNA; TRABECTEDIN;

ACUTE KIDNEY FAILURE; ADIPOCYTIC SARCOMA; ADULT; ADVANCED CANCER; ANEMIA; ARTICLE; ASTHENIA; CANCER PATIENT; CANCER SURVIVAL; CHORIORETINOPATHY; CONGESTIVE CARDIOMYOPATHY; CONTINUOUS INFUSION; DIARRHEA; DISEASE COURSE; DRUG EFFICACY; DRUG SAFETY; DRUG WITHDRAWAL; EWING SARCOMA; FATIGUE; FEMALE; FIBROSARCOMA; HEMATEMESIS; HISTOLOGY; HUMAN; HUMAN TISSUE; HYPERGLYCEMIA; INFUSION RELATED REACTION; LEIOMYOSARCOMA; MAJOR CLINICAL STUDY; MALE; METASTASIS; MULTICENTER STUDY; NAUSEA; PAIN; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; RHABDOMYOSARCOMA; SOFT TISSUE SARCOMA; SYNOVIAL SARCOMA; THORAX PAIN; THROMBOCYTOPENIA; TRACHEOBRONCHITIS; TUMOR BLEEDING;

ADIPOCYTIC SARCOMA; CIXUTUMUMAB; EWING FAMILY OF TUMOURS; INSULIN-LIKE GROWTH FACTOR RECEPTOR; LEIOMYOSARCOMA; RHABDOMYOSARCOMA; SOFT-TISSUE SARCOMA; SYNOVIAL SARCOMA;

ADULT; ANTIBODIES, MONOCLONAL; DISEASE-FREE SURVIVAL; FEMALE; HUMANS; MALE; MIDDLE AGED; NEOPLASM METASTASIS; SARCOMA; SARCOMA, EWING; TREATMENT OUTCOME; YOUNG ADULT;

EID: 84884910107     PISSN: 09598049     EISSN: 18790852     Source Type: Journal    
DOI: 10.1016/j.ejca.2013.06.010     Document Type: Article

References (40)

1. T.E. Adams, V.C. Epa, T.P. Garrett, and C.W. Ward Structure and function of the type 1 insulin-like growth factor receptor Cell Mol Life Sci 57 7 2000 1050 1093
2. Y. Wang, and Y. Sun Insulin-like growth factor receptor-1 as an anti-cancer target: blocking transformation and inducing apoptosis Curr Cancer Drug Targets 2 3 2002 191 207
3. G.O. Hellawell, G.D. Turner, D.R. Davies, R. Poulsom, S.F. Brewster, and V.M. Macaulay Expression of the type 1 insulin-like growth factor receptor is up-regulated in primary prostate cancer and commonly persists in metastatic disease Cancer Res 62 10 2002 2942 2950
4. S.J. Moschos, and C.S. Mantzoros The role of the IGF system in cancer: from basic to clinical studies and clinical applications Oncology 63 4 2002 317 332
5. M.N. Pollak, E.S. Schernhammer, and S.E. Hankinson Insulin-like growth factors and neoplasia Nat Rev Cancer 4 7 2004 505 518
6. J. Riedemann, and V.M. Macaulay IGF1R signalling and its inhibition Endocr Relat Cancer 13 Suppl. 1 2006 S33 S43
7. E.K. Rowinsky, H. Youssoufian, J.R. Tonra, P. Solomon, D. Burtrum, and D.L. Ludwig IMC-A12, a human IgG1 monoclonal antibody to the insulin-like growth factor I receptor Clin Cancer Res 13 18 Pt 2 2007 5549s 5555s
8. D. Sachdev, J.S. Hartell, A.V. Lee, X. Zhang, and D. Yee A dominant negative type I insulin-like growth factor receptor inhibits metastasis of human cancer cells J Biol Chem 279 6 2004 5017 5024
9. Y. Xie, B. Skytting, G. Nilsson, B. Brodin, and O. Larsson Expression of insulin-like growth factor-1 receptor in synovial sarcoma: association with an aggressive phenotype Cancer Res 59 15 1999 3588 3591
10. P.J. Roholl, A. Skottner, I. Prinsen, C.J. Lips, W. Den Otter, and J.A. Van Unnik Expression of insulin-like growth factor 1 in sarcomas Histopathology 16 5 1990 455 460
11. G. Merlino, and L.J. Helman Rhabdomyosarcoma - working out the pathways Oncogene 18 38 1999 5340 5348
12. L.H. Wexler, and L.J. Helman Pediatric soft tissue sarcomas CA Cancer J Clin 44 4 1994 211 247
13. J.V. Bovee, and P.C. Hogendoorn Molecular pathology of sarcomas: concepts and clinical implications Virchows Arch 456 2 2010 193 199
14. R.G. Maki Small is beautiful: insulin-like growth factors and their role in growth, development, and cancer J Clin Oncol 28 33 2010 4985 4995
15. S. Zhan, D.N. Shapiro, and L.J. Helman Activation of an imprinted allele of the insulin-like growth factor II gene implicated in rhabdomyosarcoma J Clin Invest 94 1 1994 445 448
16. T.H. Vu, C. Yballe, S. Boonyanit, and A.R. Hoffman Insulin-like growth factor II in uterine smooth-muscle tumors: maintenance of genomic imprinting in leiomyomata and loss of imprinting in leiomyosarcomata J Clin Endocrinol Metab 80 5 1995 1670 1676
17. R.N. Roy, A.H. Gerulath, A. Cecutti, and B.R. Bhavnani Loss of IGF-II imprinting in endometrial tumors: overexpression in carcinosarcoma Cancer Lett 153 1-2 2000 67 73
18. J.V. Tricoli, L.B. Rall, and C.P. Karakousis Enhanced levels of insulin-like growth factor messenger RNA in human colon carcinomas and liposarcomas Cancer Res 46 12 Pt 1 1986 6169 6173
19. A.S. Martins, D. Olmos, E. Missiaglia, and J. Shipley Targeting the insulin-like growth factor pathway in rhabdomyosarcomas: rationale and future perspectives Sarcoma 2011 2011 209736
20. S.E. Steigen, D.F. Schaeffer, R.B. West, and T.O. Nielsen Expression of insulin-like growth factor 2 in mesenchymal neoplasms Mod Pathol 22 7 2009 914 921
21. A. Girnita, L. Girnita, F. del Prete, A. Bartolazzi, O. Larsson, and M. Axelson Cyclolignans as inhibitors of the insulin-like growth factor-1 receptor and malignant cell growth Cancer Res 64 1 2004 236 242
22. A. Prieur, F. Tirode, P. Cohen, and O. Delattre EWS/FLI-1 silencing and gene profiling of Ewing cells reveal downstream oncogenic pathways and a crucial role for repression of insulin-like growth factor binding protein 3 Mol Cell Biol 24 16 2004 7275 7283
23. P.J. Houghton, C.L. Morton, and R. Gorlick Initial testing of a monoclonal antibody (IMC-A12) against IGF-1R by the pediatric preclinical testing program Pediatr Blood Cancer 54 7 2010 921 926
24. P. Therasse, S.G. Arbuck, and E.A. Eisenhauer 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 92 3 2000 205 216
25. E.L. Kaplan, and P. Meier Nonparametric estimation of incomplete observations J Am Stat Assoc 53 1958 457 481
26. R. Simon Optimal two-stage designs for phase II clinical trials Control Clin Trials 10 1 1989 1 10
27. M. Van Glabbeke, J. Verweij, I. Judson, and O.S. Nielsen Progression-free rate as the principal end-point for phase II trials in soft-tissue sarcomas Eur J Cancer 38 4 2002 543 549
28. Bramwell VH, Anderson D, Charette ML. Doxorubicin-based chemotherapy for the palliative treatment of adult patients with locally advanced or metastatic soft tissue sarcoma. Cochrane Database Syst Rev 2003;(3):CD003293.
29. K. Antman, J. Crowley, and S.P. Balcerzak An intergroup phase III randomized study of doxorubicin and dacarbazine with or without ifosfamide and mesna in advanced soft tissue and bone sarcomas J Clin Oncol 11 7 1993 1276 1285
30. P. Lorigan, J. Verweij, and Z. Papai Phase III trial of two investigational schedules of ifosfamide compared with standard-dose doxorubicin in advanced or metastatic soft tissue sarcoma: a European Organisation for Research and Treatment of Cancer Soft Tissue and Bone Sarcoma Group Study J Clin Oncol 25 21 2007 3144 3150
31. G.D. Demetri, S.P. Chawla, and M. von Mehren Efficacy and safety of trabectedin in patients with advanced or metastatic liposarcoma or leiomyosarcoma after failure of prior anthracyclines and ifosfamide: results of a randomized phase II study of two different schedules J Clin Oncol 27 25 2009 4188 4196
32. J. Verweij, S.M. Lee, and W. Ruka Randomized phase II study of docetaxel versus doxorubicin in first- and second-line chemotherapy for locally advanced or metastatic soft tissue sarcomas in adults: a study of the european organization for research and treatment of cancer soft tissue and bone sarcoma group J Clin Oncol 18 10 2000 2081 2086
33. P. Schoffski, I.L. Ray-Coquard, and A. Cioffi Activity of eribulin mesylate in patients with soft-tissue sarcoma: a phase 2 study in four independent histological subtypes Lancet Oncol 12 11 2011 1045 1052
34. M. Van Glabbeke, A.T. van Oosterom, and J.W. Oosterhuis Prognostic factors for the outcome of chemotherapy in advanced soft tissue sarcoma: an analysis of 2,185 patients treated with anthracycline-containing first-line regimens-a European Organization for Research and Treatment of Cancer Soft Tissue and Bone Sarcoma Group Study J Clin Oncol 17 1 1999 150 157
35. P. Haluska, H.M. Shaw, and G.N. Batzel Phase I dose escalation study of the anti insulin-like growth factor-I receptor monoclonal antibody CP-751,871 in patients with refractory solid tumors Clin Cancer Res 13 19 2007 5834 5840
36. Higano C, LoRusso P, Gordon M, et al. A phase I study of the recombinant human IgG1 anti-IGF-IR monoclonal antibody (Mab) IMC-A12, administered on a weekly basis to patients with advanced solid tumors: interim analysis. In: AACR-NCI-EORTC international conference on molecular targets and cancer therapeutics; San Francisco, CA, 2007, p. 168. [Abstract B19].
37. S. Sleijfer, I. Ray-Coquard, and Z. Papai Pazopanib, a multikinase angiogenesis inhibitor, in patients with relapsed or refractory advanced soft tissue sarcoma: a phase II study from the European organisation for research and treatment of cancer-soft tissue and bone sarcoma group (EORTC study 62043) J Clin Oncol 27 19 2009 3126 3132
38. A. Naing, P. LoRusso, and S. Fu Insulin growth factor-receptor (IGF-1R) antibody cixutumumab combined with the mTOR inhibitor temsirolimus in patients with refractory Ewing's sarcoma family tumors Clin Cancer Res 18 9 2012 2625 2631
39. G.K. Schwartz, W.D. Tap, and L.-X. Qin Cixutumumab and temsirolimus for patients with bone and soft-tissue sarcoma: a multicentre, open-label, phase 2 trial Lancet Oncol 14 4 2013 371 382
40. ClinicalTrials.gov. Temozolomide, cixutumumab, and combination chemotherapy in treating patients with metastatic rhabdomyosarcoma. < http://clinicaltrials.gov/show/NCT01055314 >; 2013 [accessed 19.02.13].