A phase i pharmacokinetic study of matuzumab in combination with paclitaxel in patients with EGFR-expressing advanced non-small cell lung cancer

Investigational New Drugs

Volumn 31, Issue 3, 2013, Pages 661-668

  Hartmann, J T ^a,b   Kollmannsberger, C ^b,c   Cascorbi, I ^d   Mayer, F ^b   Schittenhelm, M M ^b   Heeger, S ^e   Bokemeyer, C ^b,f  

^a UNIVERSITY OF KIEL   (Germany)

^b UNIVERSITY OF TÜBINGEN   (Germany)

^c BRITISH COLUMBIA CANCER AGENCY   (Canada)

^d UNIVERSITY HOSPITAL SCHLESWIG HOLSTEIN   (Germany)

^e MERCK KGAA   (Germany)

^f UNIVERSITY MEDICAL CENTER HAMBURG EPPENDORF   (Germany)

Author keywords

Matuzumab; NSCLC; Paclitaxel; Pharmacokinetics; Phase I

Indexed keywords

EPIDERMAL GROWTH FACTOR RECEPTOR; MATUZUMAB; PACLITAXEL;

ADULT; ADVANCED CANCER; AGED; ARTICLE; CANCER PAIN; CLINICAL ARTICLE; CONFUSION; CONTROLLED STUDY; DOSAGE SCHEDULE COMPARISON; DOSE RESPONSE; DRUG DOSE COMPARISON; DRUG DOSE ESCALATION; DRUG HYPERSENSITIVITY; DRUG SAFETY; DRUG TOLERABILITY; DYSPNEA; FEMALE; HUMAN; HYPERTENSION; LEUKOPENIA; LUNG NON SMALL CELL CANCER; MALE; MULTIPLE CYCLE TREATMENT; NEUTROPENIA; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL; PROTEIN EXPRESSION; SIDE EFFECT; TACHYCARDIA;

ADULT; AGED; ANTIBODIES, MONOCLONAL, HUMANIZED; ANTINEOPLASTIC AGENTS; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CARCINOMA, NON-SMALL-CELL LUNG; FEMALE; HUMANS; LUNG NEOPLASMS; MALE; MAXIMUM TOLERATED DOSE; MIDDLE AGED; PACLITAXEL; RECEPTOR, EPIDERMAL GROWTH FACTOR;

EID: 84879107736     PISSN: 01676997     EISSN: 15730646     Source Type: Journal    
DOI: 10.1007/s10637-012-9856-0     Document Type: Article

References (29)

1. Pirker R, Pereira JR, Szczesna A, von Pawel J, Krzakowski M, Ramlau R, Vynnychenko I, Park K, Yu CT, Ganul V, Roh JK, Bajetta E, O'Byrne K, de Marinis F, Eberhardt W, Goddemeier T, Emig M, Gatzemeier U (2009) Cetuximab plus chemotherapy in patients with advanced non-small-cell lung cancer (FLEX): an open-label randomised phase III trial. Lancet 373:1525-1531
2. Sandler A, Gray R, Perry MC, Brahmer J, Schiller JH, Dowlati A, Lilenbaum R, Johnson DH (2006) Paclitaxel-carboplatin alone or with bevacizumab for non-small-cell lung cancer. N Engl J Med 355:2542-2550
3. Pirker R, Pereira J, von Pawel J, Krzakowski M, Ramlau R, Park K, de Marinis F, Eberhardt W, Paz-Ares L, Störkel S, Schumacher K-M, von Heydebreck A, Celik I, O'Byrne K (2011) EGFR expression as a predictor of survival for first-line chemotherapy plus cetuximab in patients with advanced non-small-cell lung cancer: analysis of data from the phase 3 FLEX study. Lancet Oncol 13:33-42
4. Cappuzzo F, Ciuleanu T, Stelmakh L, Cicenas S, Szczesna A, Juhasz E, Esteban E, Molinier O, Brugger W, Melezinek I, Klingelschmitt G, Klughammer B, Giaccone G (2010) Erlotinib as maintenance treatment in advanced non-small-cell lung cancer: a multicentre, randomised, placebo-controlled phase 3 study. Lancet Oncol 11:521-529
5. Coudert B, Ciuleanu T, Park K, Wu YL, Giaccone G, Brugger W, Gopalakrishna P, Cappuzzo F (2012) Survival benefit with erlotinib maintenance therapy in patients with advanced non-small-cell lung cancer (NSCLC) according to response to first-line chemotherapy. Ann Oncol 23:388-394
6. Bria E, Milella M, Cuppone F, Novello S, Ceribelli A, Vaccaro V, Sperduti I, Gelibter A, Scagliotti GV, Cognetti F, Giannarelli D (2011) Outcome of advanced NSCLC patients harboring sensitizing EGFR mutations randomized to EGFR tyrosine kinase inhibitors or chemotherapy as first-line treatment: a meta-analysis. Ann Oncol 22:2277-2285
7. Lee DH, Park K, Kim JH, Lee JS, Shin SW, Kang JH, Ahn MJ, Ahn JS, Suh C, Kim SW (2010) Randomized Phase III trial of gefitinib versus docetaxel in non-small cell lung cancer patients who have previously received platinum-based chemotherapy. Clin Cancer Res 16:1307-1314
8. Shepherd FA, Rodrigues Pereira J, Ciuleanu T, Tan EH, Hirsh V, Thongprasert S, Campos D, Maoleekoonpiroj S, Smylie M, Martins R, van Kooten M, Dediu M, Findlay B, Tu D, Johnston D, Bezjak A, Clark G, Santabarbara P, Seymour L (2005) Erlotinib in previously treated non-small-cell lung cancer. N Engl J Med 353:123-132
9. Mok TS, Wu YL, Thongprasert S, Yang CH, Chu DT, Saijo N, Sunpaweravong P, Han B, Margono B, Ichinose Y, Nishiwaki Y, Ohe Y, Yang JJ, Chewaskulyong B, Jiang H, Duffield EL, Watkins CL, Armour AA, Fukuoka M (2009) Gefitinib or carboplatin-paclitaxel in pulmonary adenocarcinoma. N Engl J Med 361:947-957
10. Silvestri GA, Rivera MP (2005) Targeted therapy for the treatment of advanced non-small cell lung cancer: a review of the epidermal growth factor receptor antagonists. Chest 128:3975-3984
11. O'Byrne KJ, Gatzemeier U, Bondarenko I, Barrios C, Eschbach C, Martens UM, Hotko Y, Kortsik C, Paz-Ares L, Pereira JR, von Pawel J, Ramlau R, Roh JK, Yu CT, Stroh C, Celik I, Schueler A, Pirker R (2011) Molecular biomarkers in non-small-cell lung cancer: a retrospective analysis of data from the phase 3 FLEX study. Lancet Oncol 12:795-805
12. Kimura H, Sakai K, Arao T, Shimoyama T, Tamura T, Nishio K (2007) Antibody-dependent cellular cytotoxicity of cetuximab against tumor cells with wild-type or mutant epidermal growth factor receptor. Cancer Sci 98:1275-1280
13. Pao W, Chmielecki J (2010) Rational, biologically based treatment of EGFR-mutant non-small-cell lung cancer. Nat Rev Cancer 10:760-774
14. Steiner P, Joynes C, Bassi R, Wang S, Tonra JR, Hadari YR, Hicklin DJ (2007) Tumor growth inhibition with cetuximab and chemotherapy in non-small cell lung cancer xenografts expressing wild-type and mutated epidermal growth factor receptor. Clin Cancer Res 13:1540-1551
15. Schittenhelm MM, Kollmannsberger C, Oechsle K, Harlow A, Morich J, Honecker F, Kurek R, Storkel S, Kanz L, Corless CL, Wong KK, Bokemeyer C, Heinrich MC (2009) Molecular determinants of response to matuzumab in combination with paclitaxel for patients with advanced non-small cell lung cancer. Mol Cancer Ther 8:481-489
16. Schmiedel J, Blaukat A, Li S, Knochel T, Ferguson KM (2008) Matuzumab binding to EGFR prevents the conformational rearrangement required for dimerization. Cancer Cell 13:365-373
17. Meira DD, Nobrega I, de Almeida VH, Mororo JS, Cardoso AM, Silva RL, Albano RM, Ferreira CG (2009) Different antiproliferative effects of matuzumab and cetuximab in A431 cells are associated with persistent activity of the MAPK pathway. Eur J Cancer 45:1265-1273
18. Bier H, Hoffmann T, Haas I, van Lierop A (1998) Anti-(epidermal growth factor) receptor monoclonal antibodies for the induction of antibody-dependent cell-mediated cytotoxicity against squamous cell carcinoma lines of the head and neck. Cancer Immunol Immunother 46:167-173
19. Vanhoefer U, Tewes M, Rojo F, Dirsch O, Schleucher N, Rosen O, Tillner J, Kovar A, Braun AH, Trarbach T, Seeber S, Harstrick A, Baselga J (2004) 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 22:175-184
20. Graeven U, Kremer B, Sudhoff T, Killing B, Rojo F, Weber D, Tillner J, Unal C, Schmiegel W (2006) Phase I study of the humanised anti-EGFR monoclonal antibody matuzumab (EMD 72000) combined with gemcitabine in advanced pancreatic cancer. Br J Cancer 94:1293-1299
21. Rao S, Starling N, Cunningham D, Benson M, Wotherspoon A, Lupfert C, Kurek R, Oates J, Baselga J, Hill A (2008) Phase I study of epirubicin, cisplatin and capecitabine plus matuzumab in previously untreated patients with advanced oesophagogastric cancer. Br J Cancer 99:868-874
22. Rao S, Starling N, Cunningham D, Sumpter K, Gilligan D, Ruhstaller T, Valladares-Ayerbes M, Wilke H, Archer C, Kurek R, Beadman C, Oates J (2010) Matuzumab plus epirubicin, cisplatin and capecitabine (ECX) compared with epirubicin, cisplatin and capecitabine alone as first-line treatment in patients with advanced oesophago-gastric cancer: a randomised, multicentre open-label phase II study. Ann Oncol 21:2213-2219
23. Schiller JH, von Pawel J, Schutt P, Ansari RH, Thomas M, Saleh M, McCroskey RD, Pfeifer W, Marsland TA, Kloecker GH, Sebastian M, Pirker R, Kurek R, Beadman C, Socinski MA (2010) Pemetrexed with or without matuzumab as second-line treatment for patients with stage IIIB/IV non-small cell lung cancer. J Thorac Oncol 5:1977-1985
24. Kollmannsberger C, Schittenhelm M, Honecker F, Tillner J, Weber D, Oechsle K, Kanz L, Bokemeyer C (2006) A phase I study of the humanized monoclonal anti-epidermal growth factor receptor (EGFR) antibody EMD 72000 (matuzumab) in combination with paclitaxel in patients with EGFR-positive advanced non-small-cell lung cancer (NSCLC). Ann Oncol 17:1007-1013
25. Harandi A, Zaidi AS, Stocker AM, Laber DA (2009) Clinical Efficacy and Toxicity of Anti-EGFR Therapy in Common Cancers. J Oncol 2009:567486
26. Van Cutsem E, Siena S, Humblet Y, Canon JL, Maurel J, Bajetta E, Neyns B, Kotasek D, Santoro A, Scheithauer W, Spadafora S, Amado RG, Hogan N, Peeters M (2008) An open-label, single-arm study assessing safety and efficacy of panitumumab in patients with metastatic colorectal cancer refractory to standard chemotherapy. Ann Oncol 19:92-98
27. Perez-Soler R (2006) Rash as a surrogate marker for efficacy of epidermal growth factor receptor inhibitors in lung cancer. Clin Lung Cancer 8(Suppl 1):S7-S14
28. Gatzemeier U, Pluzanska A, Szczesna A, Kaukel E, Roubec J, De Rosa F, Milanowski J, Karnicka-Mlodkowski H, Pesek M, Serwatowski P, Ramlau R, Janaskova T, Vansteenkiste J, Strausz J, Manikhas GM, Von Pawel J (2007) Phase III study of erlotinib in combination with cisplatin and gemcitabine in advanced non-small-cell lung cancer: the Tarceva Lung Cancer Investigation Trial. J Clin Oncol 25:1545-1552
29. Herbst RS, Prager D, Hermann R, Fehrenbacher L, Johnson BE, Sandler A, Kris MG, Tran HT, Klein P, Li X, Ramies D, Johnson DH, Miller VA (2005) TRIBUTE: a phase III trial of erlotinib hydrochloride (OSI-774) combined with carboplatin and paclitaxel chemotherapy in advanced non-small-cell lung cancer. J Clin Oncol 23:5892-5899