A phase II trial of EMD72000 (matuzumab), a humanized anti-EGFR monoclonal antibody, in patients with platinum-resistant ovarian and primary peritoneal malignancies

Gynecologic Oncology

Volumn 104, Issue 3, 2007, Pages 727-731

  Seiden, M V ^a   Burris, H A ^b   Matulonis, U ^c   Hall, J B ^d   Armstrong, D K ^e   Speyer, J ^f   Weber, J D A ^g   Muggia, F ^f  

^a MASSACHUSETTS GENERAL HOSPITAL   (United States)

^b SARAH CANNON RESEARCH INSTITUTE   (United States)

^c DANA FARBER CANCER INSTITUTE   (United States)

^d CAROLINAS MEDICAL CENTER   (United States)

^e JOHNS HOPKINS UNIVERSITY   (United States)

^f NEW YORK UNIVERSITY MEDICAL CENTER   (United States)

^g MERCK KGAA   (Germany)

Author keywords

Anti EGFR antibody; EMD72000; Epidermal growth factor receptor; Matuzumab; Monoclonal antibody; Ovarian cancer; Ovarian neoplasm; Peritoneal neoplasm; Phase 2 clinical trial

Indexed keywords

MATUZUMAB; MONOCLONAL ANTIBODY; PLATINUM DERIVATIVE;

ABDOMINAL PAIN; ACNE; ADULT; AGE; AGED; ARTICLE; CANCER CHEMOTHERAPY; CANCER PATIENT; CANCER SURVIVAL; CENTRAL RETINA ARTERY OCCLUSION; CLINICAL ARTICLE; CLINICAL TRIAL; CONFIDENCE INTERVAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DEHYDRATION; DIARRHEA; DRUG ACTIVITY; DRUG DOSE REDUCTION; DRUG INFUSION; DRUG RESPONSE; DRY SKIN; ERYTHEMA; FATIGUE; FEMALE; FEVER; HEADACHE; HUMAN; INTESTINE OBSTRUCTION; MONOTHERAPY; MYALGIA; NAUSEA; OVARY CANCER; PANCREATITIS; PARONYCHIA; PERITONEUM CANCER; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; RASH; RIGOR; SCREENING; TUMOR GROWTH; VOMITING;

ADULT; AGED; AGED, 80 AND OVER; ANTIBODIES, MONOCLONAL; ANTINEOPLASTIC AGENTS; DRUG RESISTANCE, NEOPLASM; FEMALE; HUMANS; MIDDLE AGED; ORGANOPLATINUM COMPOUNDS; OVARIAN NEOPLASMS; PERITONEAL NEOPLASMS; RECEPTOR, EPIDERMAL GROWTH FACTOR;

EID: 33846950834     PISSN: 00908258     EISSN: 10956859     Source Type: Journal    
DOI: 10.1016/j.ygyno.2006.10.019     Document Type: Article

References (36)

1. ten Bokkel Huinink W., Gore M., Carmichael J., et al. Topotecan versus paclitaxel for the treatment of recurrent epithelial ovarian cancer. J. Clin. Oncol. 15 (1997) 2183-2193
2. Gordon A.N., Fleagle J.T., Guthrie D., et al. Recurrent epithelial ovarian carcinoma: a randomized phase III study of pegylated liposomal doxorubicin versus topotecan. J. Clin. Oncol. 19 (2001) 3312-3322
3. Gordon A.N., Tonda M., Sun S., et al. Long-term survival advantage for women treated with pegylated liposomal doxorubicin compared with topotecan in a phase 3 randomized study of recurrent and refractory epithelial ovarian cancer. Gynecol. Oncol. 95 (2004) 1-8
4. Cannistra S.A. Cancer of the ovary. N. Engl. J. Med. 351 (2004) 2519-2529
5. Berkenblit A., Seiden M.V., Matulonis U.A., et al. A phase II trial of weekly docetaxel in patients with platinum-resistant epithelial ovarian, primary peritoneal serous cancer, or fallopian tube cancer. Gynecol. Oncol. 95 (2004) 624-631
6. Harries M., and Gore M. Part II: chemotherapy for epithelial ovarian cancer-treatment of recurrent disease. Lancet Oncol. 3 (2002) 537-545
7. D'Agostino G., Amant F., Berteloot P., et al. Phase II study of gemcitabine in recurrent platinum- and paclitaxel-resistant ovarian cancer. Gynecol. Oncol. 88 (2003) 266-269
8. Garcia A.A., Blessing J.A., Lenz H.J., et al. Phase II clinical trial of capecitabine in ovarian carcinoma recurrent 6-12 months after completion of primary chemotherapy, with exploratory TS, DPD, and TP correlates: a Gynecologic Oncology Group study. Gynecol. Oncol. 96 (2005) 810-817
9. Keldsen N., Havsteen H., Vergote I., et al. Altretamine (hexamethylmelamine) in the treatment of platinum-resistant ovarian cancer: a phase II study. Gynecol. Oncol. 88 (2003) 118-122
10. Rothenberg M.L., Liu P.Y., Wilczynski S., et al. Phase II trial of vinorelbine for relapsed ovarian cancer: a Southwest Oncology Group study. Gynecol. Oncol. 95 (2004) 506-512
11. Vaidya A.P., Parnes A.D., and Seiden M.V. Rationale and clinical experience with epidermal growth factor receptor inhibitors in gynecologic malignancies. Curr. Treat. Options Oncol. 6 (2005) 103-114
12. Campiglio M., Ali S., Knyazev P.G., et al. Characteristics of EGFR family-mediated HRG signals in human ovarian cancer. J. Cell. Biochem. 73 (1999) 522-532
13. Fischer O.M., Hart S., Gschwind A., et al. EGFR signal transactivation in cancer cells. Biochem. Soc. Trans. 31 (2003) 1203-1208
14. Lebeau A., Unholzer A., Amann G., et al. EGFR, HER-2/neu, cyclin D1, p21 and p53 in correlation to cell proliferation and steroid hormone receptor status in ductal carcinoma in situ of the breast. Breast Cancer Res. Treat. 79 (2003) 187-198
15. Fischer-Colbrie J., Witt A., Heinzl H., et al. EGFR and steroid receptors in ovarian carcinoma: comparison with prognostic parameters and outcome of patients. Anticancer Res. 17 (1997) 613-619
16. Nielsen J.S., Jakobsen E., Holund B., et al. Prognostic significance of p53, Her-2, and EGFR overexpression in borderline and epithelial ovarian cancer. Int. J. Gynecol. Cancer 14 (2004) 1086-1096
17. Skirnisdottir I., Seidal T., and Sorbe B. A new prognostic model comprising p53, EGFR, and tumor grade in early stage epithelial ovarian carcinoma and avoiding the problem of inaccurate surgical staging. Int. J. Gynecol. Cancer 14 (2004) 259-270
18. Elie C., Geay J.F., Morcos M., et al. Lack of relationship between EGFR-1 immunohistochemical expression and prognosis in a multicentre clinical trial of 93 patients with advanced primary ovarian epithelial cancer (GINECO group). Br. J. Cancer 91 (2004) 470-475
19. Ferrandina G., Ranelletti F.O., Lauriola L., et al. Cyclooxygenase-2 (COX-2), epidermal growth factor receptor (EGFR), and Her-2/neu expression in ovarian cancer. Gynecol. Oncol. 85 (2002) 305-310
20. Skirnisdottir I., Sorbe B., and Seidal T. The growth factor receptors HER-2/neu and EGFR, their relationship, and their effects on the prognosis in early stage (FIGO I-II) epithelial ovarian carcinoma. Int. J. Gynecol. Cancer 11 (2001) 119-129
21. Cunningham D., Humblet Y., Siena S., et al. Cetuximab monotherapy and cetuximab plus irinotecan in irinotecan-refractory metastatic colorectal cancer. N. Engl. J. Med. 351 (2004) 337-345
22. Shepherd F.A., Rodrigues Pereira J., Ciuleanu T., et al. Erlotinib in previously treated non-small-cell lung cancer. N. Engl. J. Med. 353 (2005) 123-132
23. Vanhoefer U., Tewes M., Rojo F., et al. Phase I study of the humanized antiepidermal growth factor receptor monoclonal antibody EMD72000 in patients with advanced solid tumors that express the epidermal growth factor receptor. J. Clin. Oncol. 22 (2004) 175-184
24. Sawaki M., Ito Y., Tada K., et al. Efficacy and safety of trastuzumab as a single agent in heavily pretreated patients with HER-2/neu-overexpressing metastatic breast cancer. Tumori 90 (2004) 40-43
25. Slamon D.J., Leyland-Jones B., Shak S., et al. Use of chemotherapy plus a monoclonal antibody against HER2 for metastatic breast cancer that overexpresses HER2. N. Engl. J. Med. 344 (2001) 783-792
26. Saltz L.B., Meropol N.J., Loehrer Sr. P.J., et al. Phase II trial of cetuximab in patients with refractory colorectal cancer that expresses the epidermal growth factor receptor. J. Clin. Oncol. 22 (2004) 1201-1208
27. Reynolds N.A., and Wagstaff A.J. Cetuximab: in the treatment of metastatic colorectal cancer. Drugs 64 (2004) 109-118 [discussion 2004; 119-21]
28. Campos S., Hamid O., Seiden M.V., et al. A multicenter, randomized phase II trial of oral CI-1033 for previously treated advanced ovarian Cancer. J Clin Oncol 23 (2005) 5597-5604
29. del Carmen M.G., Fuller A.F., Matulonis U., et al. Phase II trial of anastrozole in women with asymptomatic mullerian cancer. Gynecol. Oncol. 91 (2003) 596-602
30. Bookman M.A., Darcy K.M., Clarke-Pearson D., Boothby R.A., and Horowitz I.R. Evaluation of monoclonal humanized anti-HER2 antibody, trastuzumab, in patients with recurrent or refractory ovarian or primary peritoneal carcinoma with overexpression of HER2: a phase II trial of the Gynecologic Oncology Group. J. Clin. Oncol. 21 (2003) 283-290
31. Toyooka S., Kiura K., and Mitsudomi T. EGFR mutation and response of lung cancer to gefitinib. N. Engl. J. Med. 352 (2005) 2136 [author reply]
32. Taja-Chayeb L., Candelaria M., Brom R., et al. Response to gefitinib in bronchioloalveolar carcinoma in the absence of EGFR mutation. Lung Cancer 50 (2005) 259-263
33. Kim K.S., Jeong J.Y., Kim Y.C., et al. Predictors of the response to gefitinib in refractory non-small cell lung cancer. Clin. Cancer Res. 11 (2005) 2244-2251
34. Lynch T.J., Bell D.W., Sordella R., et al. Activating mutations in the epidermal growth factor receptor underlying responsiveness of non-small-cell lung cancer to gefitinib. N. Engl. J. Med. 350 (2004) 2129-2139
35. Chung K.Y., Shia J., Kemeny N.E., et al. Cetuximab shows activity in colorectal cancer patients with tumors that do not express the epidermal growth factor receptor by immunohistochemistry. J. Clin. Oncol. 23 (2005) 1803-1810
36. Xing D., and Orsulic S. Modeling resistance to pathway-targeted therapy in ovarian cancer. Cell Cycle 4 (2005) 1004-1006