Phase 1 pharmacokinetic study of MK-0646 (dalotuzumab), an anti-insulin-like growth factor-1 receptor monoclonal antibody, in combination with cetuximab and irinotecan in Japanese patients with advanced colorectal cancer

Cancer Chemotherapy and Pharmacology

Volumn 72, Issue 3, 2013, Pages 643-652

  Doi, Toshihiko ^a   Muro, Kei ^b   Yoshino, Takayuki ^a   Fuse, Nozomu ^a   Ura, Takashi ^b   Takahari, Daisuke ^b   Feng, Hwa Ping ^c   Shimamoto, Takashi ^d   Noguchi, Kazuo ^d   Ohtsu, Atsushi ^a  

^a NATIONAL CANCER CENTER HOSPITAL   (Japan)

^b AICHI CANCER CENTER HOSPITAL   (Japan)

^c MERCK RESEARCH LABORATORIES   (United States)

^d Merck Sharp Dohm Res Labs Japan   (Japan)

Author keywords

Anti IGF 1R antibody; Colorectal cancer; MK 0646; Pharmacokinetic interactions; Phase I study

Indexed keywords

CETUXIMAB; DALOTUZUMAB; FIRTECAN; IRINOTECAN;

ACNE; ADULT; ADVANCED CANCER; ADVERSE OUTCOME; AGED; ALOPECIA; ANEMIA; ANTINEOPLASTIC ACTIVITY; AREA UNDER THE CURVE; ARTICLE; CANCER COMBINATION CHEMOTHERAPY; CLINICAL ARTICLE; COLORECTAL CANCER; CONSTIPATION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DECREASED APPETITE; DERMATITIS ACNEIFORM; DIARRHEA; DRUG CLEARANCE; DRUG EFFICACY; DRUG FEVER; DRUG HALF LIFE; DRUG SAFETY; DRUG TOLERABILITY; DRY SKIN; FATIGUE; FEMALE; HUMAN; HYPERGLYCEMIA; HYPOALBUMINEMIA; HYPOMAGNESEMIA; JAPANESE; LEUKOPENIA; LOADING DRUG DOSE; LYMPHOCYTOPENIA; MALE; MAXIMUM PLASMA CONCENTRATION; NAUSEA; NEUTROPENIA; OUTCOME ASSESSMENT; PARONYCHIA; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL; PRURITUS; SIDE EFFECT; SKIN DISEASE; STOMATITIS; THROMBOCYTOPENIA; TIME TO MAXIMUM PLASMA CONCENTRATION; VOMITING; WEIGHT REDUCTION;

AGED; ANTIBODIES, MONOCLONAL; ANTIBODIES, MONOCLONAL, HUMANIZED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; AREA UNDER CURVE; CAMPTOTHECIN; COLORECTAL NEOPLASMS; DRUG INTERACTIONS; FEMALE; HUMANS; JAPAN; MALE; MAXIMUM TOLERATED DOSE; MIDDLE AGED; RECEPTOR, IGF TYPE 1; TREATMENT OUTCOME;

EID: 84883490014     PISSN: 03445704     EISSN: 14320843     Source Type: Journal    
DOI: 10.1007/s00280-013-2240-8     Document Type: Article

References (24)

1. Saltz LB, Minsky B (2002) Adjuvant therapy of cancers of the colon and rectum. Surg Clin North Am 82:1035-1058
2. Tournigand C, André T, Achille E, Lledo G, Flesh M, Mery-Mignard D et al (2004) FOLFIRI followed by FOLFOX6 or the reverse sequence in advanced colorectal cancer: a randomized GERCOR study. J Clin Oncol 22:229-237
3. Czito BG, Hong TJ, Cohen DP, Tyler DS, Lee CG, Anscher MS et al (2004) A phase I trial of preoperative eniluracil plus 5-fluorouracil and radiation for locally advanced or unresectable adenocarcinoma of the rectum and colon. Int J Radiat Oncol Biol Phys 58:779-785
4. Veronese ML, Sun W, Giantonio B, Berlin J, Shults J, Davis L et al (2005) A phase II trial of gefitinib with 5-fluorouracil, leucovorin, and irinotecan in patients with colorectal cancer. Br J Cancer 92:1846-1849
5. Cohen S (2004) Origins of growth factors: NGF and EGF. Ann NY Acad Sci 1038:98-102
6. Resnick MB, Routhier J, Konkin T, Sabo E, Pricolo VE (2004) Epidermal growth factor receptor, c-MET, beta-catenin, and p53 expression as prognostic indicators in stage II colon cancer: a tissue microarray study. Clin Cancer Res 10:3069-3075
7. Galizia G, Lieto E, Ferraraccio F, De Vita F, Castellano P, Orditura M et al (2006) Prognostic significance of epidermal growth factor receptor expression in colon cancer patients undergoing curative surgery. Ann Surg Oncol 13:823-835
8. Yasui W, Sumiyoshi H, Hata J, Kameda T, Ochiai A, Ito H et al (1988) Expression of epidermal growth factor receptor in human gastric and colonic carcinomas. Cancer Res 48:137-141
9. Cunningham D, Humblet Y, Siena S, Khayat D, Bleiberg H, Santoro A et al (2004) Cetuximab monotherapy and cetuximab plus irinotecan in irinotecan-refractory metastatic colorectal cancer. N Engl J Med 351:337-345
10. Goetsch L, Gonzalez A, Leger O, Beck A, Pauwels PJ, Haeuw JF et al (2005) A recombinant humanized anti-insulin-like growth factor receptor type I antibody (h7C10) enhances the antitumor activity of vinorelbine and anti-epidermal growth factor receptor therapy against human cancer xenografts. Int J Cancer 113:316-328
11. Adams TE, McKern NM, Ward CW (2004) Signalling by the type 1 insulin-like growth factor receptor: interplay with the epidermal growth factor receptor. Growth Factors 22:89-95
12. Atzori F, Tabernero J, Cervantes A, Prudkin L, Andreu J, Rodríguez-Braun E et al (2011) A phase I pharmacokinetic and pharmacodynamic study of dalotuzumab (MK-0646), an anti-insulin-like growth factor-1 receptor monoclonal antibody, in patients with advanced solid tumors. Clin Cancer Res 17:6304-6312. doi: 10.1158/1078-0432.CCR-10-3336
13. Watkins DJ, Tabernero J, Schmoll HJ, Trarbach T, Ramos FJ, Hsu K et al (2009) A phase II study of the anti-IGFR antibody MK-0646 in combination with cetuximab and irinotecan in the treatment of chemorefractory metastatic colorectal cancer. J Clin Oncol 27(Supp 15):abstract 4127
14. Weroha SJ, Haluska P (2008) IGF-1 receptor inhibitors in clinical trials - early lessons. J Mammary Gland Biol Neoplasia 13:471-483. doi: 10.1007/s10911-008-9104-6
15. Delbaldo C, Pierga JY, Dieras V, Faivre S, Laurence V, Vedovato JC et al (2005) Pharmacokinetic profile of cetuximab (Erbitux™) alone and in combination with irinotecan in patients with advanced EGFR-positive adenocarcinoma. Eur J Cancer 41:1739-1745
16. Lièvre A, Bachet JB, Le Corre D, Boige V, Landi B, Emile JF et al (2006) KRAS mutation status is predictive of response to cetuximab therapy in colorectal cancer. Cancer Res 66:3992-3995
17. Van Cutsem E, Köhne CH, Hitre E, Zaluski J, Chang Chien CR, Makhson A et al (2009) Cetuximab and chemotherapy as initial treatment for metastatic colorectal cancer. N Engl J Med 360:1408-1417. doi: 10.1056/NEJMoa0805019
18. Karapetis CS, Khambata-Ford S, Jonker DJ, O'Callaghan CJ, Tu D, Tebbutt NC et al (2008) K-ras mutations and benefit from cetuximab in advanced colorectal cancer. N Engl J Med 359:1757-1765. doi: 10.1056/NEJMoa0804385
19. Tahara M, Shirao K, Boku N, Yamaguchi K, Komatsu Y, Inaba Y et al (2008) Multicenter phase II study of cetuximab plus irinotecan in metastatic colorectal carcinoma refractory to irinotecan, oxaliplatin and fluoropyrimidines. Jpn J Clin Oncol 38:762-769. doi: 10.1093/jjco/hyn102
20. Watkins DJ, Tabernero J, Schmoll H, Trarbach T, Ramos FJ, Howe J et al (2011) A randomized phase II/III study of the anti-IGF-1R antibody MK-0646 (dalotuzumab) in combination with cetuximab (Cx) and irinotecan (Ir) in the treatment of chemorefractory metastatic colorectal cancer (mCRC) with wild-type (wt) KRAS status. J Clin Oncol 29(Suppl):abstract 3501
21. Watkins DJ, Ayers M, Cunningham D, Tabernero J, Tejpar S, Kim TY et al (2012) Molecular analysis of the randomized phase II/III study of the anti-IGF-1R antibody dalotuzumab (MK-0646) in combination with cetuximab (Cx) and irinotecan (Ir) in the treatment of chemorefractory KRAS wild-type metastatic colorectal cancer (mCRC). J Clin Oncol 30(Suppl):abstract 3531
22. Reidy DL, Vakiani E, Fakih MG, Saif MW, Hecht JR, Goodman-Davis N et al (2010) Randomized, phase II study of the insulin-like growth factor-1 receptor inhibitor IMC-A12, with or without cetuximab, in patients with cetuximab- or panitumumab-refractory metastatic colorectal cancer. J Clin Oncol 28:4240-4246. doi: 10.1200/JCO.2010.30.4154
23. Ramalingam SS, Spigel DR, Chen D, Steins MB, Engelman JA, Schneider CP et al (2011) Randomized phase II study of erlotinib in combination with placebo or R1507, a monoclonal antibody to insulin-like growth factor-1 receptor, for advanced-stage non-small-cell lung cancer. J Clin Oncol 29:4574-4580. doi: 10.1200/JCO.2011.36.6799
24. Jassem J, Langer CJ, Karp DD, Mok T, Benner RJ, Green SJ et al (2010) Randomized, open label, phase III trial of figitumumab in combination with paclitaxel and carboplatin versus paclitaxel and carboplatin in patients with non-small cell lung cancer (NSCLC). J Clin Oncol 28(Suppl 15):abstract 7500