Figitumumab combined with carboplatin and paclitaxel in treatment-naïve Japanese patients with advanced non-small cell lung cancer

Investigational New Drugs

Volumn 30, Issue 4, 2012, Pages 1548-1556

  Goto, Yasushi ^a   Sekine, Ikuo ^a   Tanioka, Maki ^a   Shibata, Takashi ^a   Tanai, Chiharu ^a   Asahina, Hajime ^a   Nokihara, Hiroshi ^a   Yamamoto, Noboru ^a   Kunitoh, Hideo ^a   Ohe, Yuichiro ^a   Kikkawa, Hironori ^b   Ohki, Emiko ^b   Tamura, Tomohide ^a  

^a NATIONAL CANCER CENTER HOSPITAL   (Japan)

^b PFIZER INC   (United States)

Author keywords

Carboplatin; Figitumumab; Non small cell lung cancer; Paclitaxel

Indexed keywords

CARBOPLATIN; FIGITUMUMAB; HUMAN GROWTH HORMONE; PACLITAXEL; SOMATOMEDIN BINDING PROTEIN 3; SOMATOMEDIN C;

ADULT; ADVANCED CANCER; AGED; ANEMIA; ANOREXIA; AREA UNDER THE CURVE; ARTICLE; CHEMOTHERAPY INDUCED EMESIS; CLINICAL ARTICLE; DIARRHEA; DRUG DOSE COMPARISON; DRUG DOSE ESCALATION; DRUG HYPERSENSITIVITY; DRUG RESPONSE; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; FEMALE; HUMAN; HYPERGLYCEMIA; HYPERKALEMIA; HYPERMAGNESEMIA; HYPERURICEMIA; HYPOGLYCEMIA; HYPONATREMIA; JAPANESE; LEUKOPENIA; LUNG NON SMALL CELL CANCER; MALE; MAXIMUM PLASMA CONCENTRATION; MULTIPLE CYCLE TREATMENT; NEUTROPENIA; OPEN STUDY; PERIPHERAL NEUROPATHY; PHASE 1 CLINICAL TRIAL; PLASMA CONCENTRATION-TIME CURVE; PRIORITY JOURNAL; PROTEIN BLOOD LEVEL; SENSORY NEUROPATHY; SIDE EFFECT; SODIUM BLOOD LEVEL; THROMBOCYTOPENIA;

ADULT; AGED; ANTIBODIES, MONOCLONAL; ANTINEOPLASTIC AGENTS; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; ASIAN CONTINENTAL ANCESTRY GROUP; CARBOPLATIN; CARCINOMA, NON-SMALL-CELL LUNG; DOSE-RESPONSE RELATIONSHIP, DRUG; FEMALE; HUMANS; JAPAN; LUNG NEOPLASMS; MALE; MIDDLE AGED; NEOPLASM STAGING; PACLITAXEL; TIME FACTORS; TREATMENT OUTCOME; TUMOR MARKERS, BIOLOGICAL; YOUNG ADULT;

EID: 84866707774     PISSN: 01676997     EISSN: 15730646     Source Type: Journal    
DOI: 10.1007/s10637-011-9715-4     Document Type: Article

References (23)

1. Pollak MN, Schernhammer ES, Hankinson SE. (2004) Insulin-like growth factors and neoplasia. Nat Rev Canc 4:505-518
2. Sachdev D, Yee D. (2007) Disrupting insulin-like growth factor signaling as a potential cancer therapy. Mol Canc Therapeut 6:1-12
3. Samani AA, Yakar S, LeRoith D, Brodt P. (2007) The role of the IGF system in cancer growth and metastasis: overview and recent insights. Endocr Rev 28:20-47
4. Favoni RE, de Cupis A, Ravera F, Cantoni C, Pirani P, Ardizzoni A, Noonan D, Biassoni R. (1994) Expression and function of the insulin-like growth factor I system in human non-small-cell lung cancer and normal lung cell lines. Int J Canc 56:858-866
5. Gualberto A, Karp DD. (2009) Development of the monoclonal antibody figitumumab, targeting the insulin-like growth factor-1 receptor, for the treatment of patients with non-small-cell lung cancer. Clin Lung Canc 10:273-280
6. Kaiser U, Schardt C, Brandscheidt D, Wollmer E, Havemann K. (1993) Expression of insulin-like growth factor receptors I and II in normal human lung and in lung cancer. J Canc Res Clin Oncol 119:665-668
7. Gualberto A, Pollak M. (2009) Emerging role of insulin-like growth factor receptor inhibitors in oncology: early clinical trial results and future directions. Oncogene 28:3009-3021
8. Haluska P, Shaw HM, Batzel GN, Yin D, Molina JR, Molife LR, Yap TA, Roberts ML, Sharma A, Gualberto A, Adjei AA, de Bono JS. (2007) 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 Canc Res 13:5834-5840
9. Haluska P, Worden F, Olmos D, Yin D, Schteingart D, Batzel GN, Paccagnella ML, de Bono JS, Gualberto A, Hammer GD. (2010) Safety, tolerability, and pharmacokinetics of the anti-IGF-1R monoclonal antibody figitumumab in patients with refractory adrenocortical carcinoma. Canc Chemother Pharmacol 65:765-773
10. Lacy MQ, Alsina M, Fonseca R, Paccagnella ML, Melvin CL, Yin D, Sharma A, Enriquez Sarano M, Pollak M, Jagannath S, Richardson P, Gualberto A. (2008) Phase I, pharmacokinetic and pharmacodynamic study of the anti-insulinlike growth factor type 1 Receptor monoclonal antibody CP-751, 871 in patients with multiple myeloma. J Clin Oncol 26:3196-3203
11. Olmos D, Postel-Vinay S, Molife LR, Okuno SH, Schuetze SM, Paccagnella ML, Batzel GN, Yin D, Pritchard-Jones K, Judson I, Worden FP, Gualberto A, Scurr M, de Bono JS, Haluska P. (2010) Safety, pharmacokinetics, and preliminary activity of the anti-IGF- 1R antibody figitumumab. (CP-751, 871) in patients with sarcoma and Ewing's sarcoma: a phase 1 expansion cohort study. Lancet Oncol 11:129-135
12. Gualberto A. (2010) Figitumumab. (CP-751, 871) for cancer therapy. Expert Opin Biol Ther 10:575-585
13. Karp DD, Paz-Ares LG, Novello S, Haluska P, Garland L, Cardenal F, Blakely LJ, Eisenberg PD, Langer CJ, Blumenschein G Jr, Johnson FM, Green S, Gualberto A. (2009) Phase II study of the anti-insulin-like growth factor type 1 receptor antibody CP- 751, 871 in combination with paclitaxel and carboplatin in previously untreated, locally advanced, or metastatic non-smallcell lung cancer. J Clin Oncol 27:2516-2522
14. Therasse P, Arbuck SG, Eisenhauer EA, Wanders J, Kaplan RS, Rubinstein L, Verweij J, Van Glabbeke M, van Oosterom AT, Christian MC, Gwyther SG. (2000) 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 Canc Inst 92:205-216
15. Javle M, Varahachary GR, Bhosale P, Ukegbu L, Overman MJ, Shroff RT, Wolff RA, Abbruzzese JL. (2010) Phase I study of MK0646, a humanized monoclonal antibody against IGF-IR in combination with gemcitabine or gemcitabine plus erlotinib for advanced previously untreated pancreatic cancer. Poster presented at the 2010 American Society of Clinical Oncology Gastrointestinal Symposium, January 22-24, Orlando, FL, USA. (abstr. 131)
16. Patel S, Pappo A, Crowley J, Reinke D, Eid J, Ritland S, Chawla S, Staddon A, Maki R, Vassal G, Helman L. (2009) A SARC global collaborative phase II trial of R1507, a recombinant human monoclonal antibody to the insulin-like growth factor-1 receptor. (IGF1R) in patients with recurrent or refractory sarcomas. J Clin Oncol 27(15s). (abstr. 10503)
17. Malempati S, Weigel B, Ingle AM, Ahern CH, Carroll JM, Roberts CT Jr, Fox FE, Voss S, Adamson PC, Blaney SM. (2009) A phase I trial and pharmacokinetic study of IMC-A12 in pediatric patients with relapsed/refractory solid tumors: a Children's Oncology Group Phase I Consortium study. J Clin Oncol 27. (15s). (abstr. 10013)
18. Gandara DR, Kawaguchi T, Crowley J, Moon J, Furuse K, Kawahara M, Teramukai S, Ohe Y, Kubota K, Williamson SK, Gautschi O, Lenz HJ, McLeod HL, Lara PN Jr, Coltman CA Jr, Fukuoka M, Saijo N, Fukushima M, Mack PC. (2009) Japanese- US common-arm analysis of paclitaxel plus carboplatin in advanced non-small-cell lung cancer: a model for assessing population-related pharmacogenomics. J Clin Oncol 27:3540-3546
19. Spitz MR, Barnett MJ, Goodman GE, Thornquist MD, Wu X, Pollak M. (2002) Serum insulin-like growth factor. (IGF) and IGF-binding protein levels and risk of lung cancer: a casecontrol study nested in the beta-Carotene and Retinol Efficacy Trial Cohort. Canc Epidemiol Biomarkers Prev 11:1413-1418
20. Walenkamp MJ, Wit JM. (2006) Genetic disorders in the growth hormone-insulin-like growth factor-I axis. Horm Res 66:221-230
21. Hixon M, Gualberto A, Demers L, Paz-Ares LG, Novello S, Blakely LJ, Langer CL, Lipton A, Pollak M, Karp DD. (2009) Plasma levels of free insulin-like growth factor I predict the clinical benefit of the IGF-IR inhibitor figitumumab. (CP- 751, 871). J Clin Oncol 27(15s). (abstr. 3539)
22. Holmes MD, Pollak MN, Hankinson SE. (2002) Lifestyle correlates of plasma insulin-like growth factor I and insulin like growth factor binding protein 3 concentrations. Canc Epidemiol Biomarkers 11:862-867
23. Jassem J, Langer CJ, Karp DD, Mok T, Benner RJ, Green SJ, Park K, Novello S, Strausz J, Gualberto A. (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(15s). (abstr. 7500)