Phase 1b dose-finding study of motesanib with docetaxel or paclitaxel in patients with metastatic breast cancer

Breast Cancer Research and Treatment

Volumn 135, Issue 1, 2012, Pages 241-252

  De Boer, Richard H ^a,b   Kotasek, Dusan ^c   White, Shane ^d   Koczwara, Bogda ^e   Mainwaring, Paul ^f   Chan, Arlene ^g   Melara, Rebeca ^h   Ye, Yining ^h   Adewoye, Adeboye H ^h   Sikorski, Robert ^h   Kaufman, Peter A ⁱ  

^a ROYAL MELBOURNE HOSPITAL   (Australia)

^b Western Hospital   (Australia)

^c Ashford Cancer Centre   (Australia)

^d AUSTIN HEALTH   (Australia)

^e FLINDERS UNIVERSITY   (Australia)

^f Mater Private Hospital Brisbane   (Australia)

^g Mount Hospital   (Australia)

^h AMGEN INC   (United States)

ⁱ NORRIS COTTON CANCER CENTER   (United States)

Author keywords

Angiogenesis; Breast cancer; Chemotherapy; Motesanib; VEGF

Indexed keywords

DOCETAXEL; MOTESANIB; PACLITAXEL;

ACUTE RESPIRATORY FAILURE; ADULT; AGED; AMYLASE BLOOD LEVEL; AREA UNDER THE CURVE; ARTHRALGIA; ARTICLE; ASTHENIA; BLEEDING; BREAST CANCER; BRONCHOPNEUMONIA; CANCER COMBINATION CHEMOTHERAPY; CANCER SURVIVAL; CHOLECYSTITIS; CLINICAL ARTICLE; CONSCIOUSNESS LEVEL; DEEP VEIN THROMBOSIS; DIARRHEA; DIPLOPIA; DISEASE SEVERITY; DOSE CALCULATION; DOSE RESPONSE; DRUG BLOOD LEVEL; DRUG DOSE COMPARISON; DRUG DOSE ESCALATION; DRUG EFFICACY; DRUG FATALITY; DRUG FEVER; DRUG POTENTIATION; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; ECZEMA; FATIGUE; FEBRILE NEUTROPENIA; FEMALE; HAND FOOT SYNDROME; HEART EJECTION FRACTION; HUMAN; HYPERBILIRUBINEMIA; HYPERTENSION; HYPOKALEMIA; HYPOTHYROIDISM; INFLUENZA; LETHARGY; MAXIMUM PLASMA CONCENTRATION; METASTASIS; MIGRAINE; MULTIPLE CYCLE TREATMENT; MULTIPLE ORGAN FAILURE; NEUTROPENIA; PHASE 1 CLINICAL TRIAL; PNEUMONIA; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; SEPSIS; SIDE EFFECT; THROMBOCYTOPENIA; VEIN THROMBOSIS;

ADULT; AGED; AGED, 80 AND OVER; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; BREAST NEOPLASMS; DISEASE-FREE SURVIVAL; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG ADMINISTRATION SCHEDULE; FEMALE; HUMANS; INDOLES; MAXIMUM TOLERATED DOSE; MIDDLE AGED; NIACINAMIDE; PACLITAXEL; PROTO-ONCOGENE PROTEINS C-KIT; RECEPTORS, PLATELET-DERIVED GROWTH FACTOR; TAXOIDS; VASCULAR ENDOTHELIAL GROWTH FACTOR RECEPTOR-1; VASCULAR ENDOTHELIAL GROWTH FACTOR RECEPTOR-2; VASCULAR ENDOTHELIAL GROWTH FACTOR RECEPTOR-3;

EID: 84865129850     PISSN: 01676806     EISSN: 15737217     Source Type: Journal    
DOI: 10.1007/s10549-012-2135-0     Document Type: Article

References (31)

1. Guarneri V, Conte P (2009) Metastatic breast cancer: therapeutic options according to molecular subtypes and prior adjuvant therapy. Oncologist 14(7):645-656. doi: 10.1634/theoncologist.2009-0078
2. Gordon MS, Mendelson DS, Kato G (2009) Tumor angiogenesis and novel antiangiogenic strategies. Int J Cancer 126(8):1777-1787. doi: doi: 10.1002/ijc.25026
3. Foekens JA, Peters HA, Grebenchtchikov N, Look MP, Meijer-van Gelder ME, Geurts-Moespot A, van der Kwast TH, Sweep CG, Klijn JG (2001) High tumor levels of vascular endothelial growth factor predict poor response to systemic therapy in advanced breast cancer. Cancer Res 61(14):5407-5414 (Pubitemid 32694919)
4. Linderholm B, Grankvist K, Wilking N, Johansson M, Tavelin B, Henriksson R (2000) Correlation of vascular endothelial growth factor content with recurrences, survival, and first relapse site in primary node-positive breast carcinoma after adjuvant treatment. J Clin Oncol 18(7):1423-1431 (Pubitemid 30205387)
5. Giovannini M, Aldrighetti D, Zucchinelli P, Belli C, Villa E (2010) Antiangiogenic strategies in breast cancer management. Crit Rev Oncol Hematol 76(1):13-35. doi: 10.1016/j.critrevonc.2009.12.004
6. Polverino A, Coxon A, Starnes C, Diaz Z, DeMelfi T, Wang L, Bready J, Estrada J, Cattley R, Kaufman S, Chen D, Gan Y, Kumar G, Meyer J, Neervannan S, Alva G, Talvenheimo J, Montestruque S, Tasker A, Patel V, Radinsky R, Kendall R (2006) AMG 706, an oral, multikinase inhibitor that selectively targets vascular endothelial growth factor, platelet-derived growth factor, and kit receptors, potently inhibits angiogenesis and induces regression in tumor xenografts. Cancer Res 66(17):8715-8721. doi: 10.1158/0008-5472.can-05-4665 (Pubitemid 44449188)
7. Rosen LS, Kurzrock R, Mulay M, Van Vugt A, Purdom M, Ng C, Silverman J, Koutsoukos A, Sun YN, Bass MB, Xu RY, Polverino A, Wiezorek JS, Chang DD, Benjamin R, Herbst RS (2007) Safety, pharmacokinetics, and efficacy of AMG 706, an oral multikinase inhibitor, in patients with advanced solid tumors. J Clin Oncol 25(17):2369-2376. doi: 10.1200/JCO.2006.07.8170 (Pubitemid 46999207)
8. Sherman SI, Wirth LJ, Droz JP, Hofmann M, Bastholt L, Martins RG, Licitra L, Eschenberg MJ, Sun YN, Juan T, Stepan DE, Schlumberger MJ (2008) Motesanib diphosphate in progressive differentiated thyroid cancer. N Engl J Med 359(1):31-42. doi: 10.1056/NEJMoa075853 (Pubitemid 351931094)
9. Blumenschein GR Jr, Reckamp K, Stephenson GJ, O'Rourke T, Gladish G, McGreivy J, Sun YN, Ye Y, Parson M, Sandler A (2010) Phase 1b study of motesanib, an oral angiogenesis inhibitor, in combination with carboplatin/paclitaxel and/or panitumumab for the treatment of advanced non-small cell lung cancer. Clin Cancer Res 16(1):279-290. doi: 10.1158/1078-0432.ccr-09-1675
10. Coxon A, Bush T, Saffran D, Kaufman S, Belmontes B, Rex K, Hughes P, Caenepeel S, Rottman JB, Tasker A, Patel V, Kendall R, Radinsky R, Polverino A (2009) Broad antitumor activity in breast cancer xenografts by motesanib, a highly selective, oral inhibitor of vascular endothelial growth factor, platelet-derived growth factor, and Kit receptors. Clin Cancer Res 15(1):110-118. doi: 10.1158/1078-0432.CCR-08-1155
11. Sweeney CJ, Miller KD, Sissons SE, Nozaki S, Heilman DK, Shen J, Sledge GW Jr (2001) The antiangiogenic property of docetaxel is synergistic with a recombinant humanized monoclonal antibody against vascular endothelial growth factor or 2-methoxyestradiol but antagonized by endothelial growth factors. Cancer Res 61(8):3369-3372 (Pubitemid 32695027)
12. 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 Cancer Inst 92(3):205-216
13. Cancer Therapy Evaluation Program (2006) Common Terminology Criteria for Adverse Events v3.0 (CTCAE). http://ctep.cancer.gov/protocoldevelopment/ electronic-applications/docs/ctcaev3.pdf. Accessed 10 April 2012
14. Bass MB, Sherman SI, Schlumberger MJ, Davis MT, Kivman L, Khoo HM, Notari KH, Peach M, Hei YJ, Patterson SD (2010) Biomarkers as predictors of response to treatment with motesanib in patients with progressive advanced thyroid cancer. J Clin Endocrinol Metab 95(11):5018-5027. doi: 10.1210/jc.2010-0947
15. Eskens FA, Verweij J (2006) The clinical toxicity profile of vascular endothelial growth factor (VEGF) and vascular endothelial growth factor receptor (VEGFR) targeting angiogenesis inhibitors; a review. Eur J Cancer 42(18):3127-3139. doi: 10.1016/j.ejca.2006.09.015 (Pubitemid 44869016)
16. Miller K, Wang M, Gralow J, Dickler M, Cobleigh M, Perez EA, Shenkier T, Cella D, Davidson NE (2007) Paclitaxel plus bevacizumab versus paclitaxel alone for metastatic breast cancer. N Engl J Med 357(26):2666-2676. doi: 10.1056/NEJMoa072113
17. Ramaswamy B, Elias AD, Kelbick NT, Dodley A, Morrow M, Hauger M, Allen J, Rhoades C, Kendra K, Chen HX, Eckhardt SG, Shapiro CL (2006) Phase II trial of bevacizumab in combination with weekly docetaxel in metastatic breast cancer patients. Clin Cancer Res 12(10):3124-3129. doi: 10.1158/1078-0432.CCR-05-2603 (Pubitemid 43837360)
18. Motzer RJ, Rini BI, Bukowski RM, Curti BD, George DJ, Hudes GR, Redman BG, Margolin KA, Merchan JR, Wilding G, Ginsberg MS, Bacik J, Kim ST, Baum CM, Michaelson MD (2006) Sunitinib in patients with metastatic renal cell carcinoma. JAMA 295(21):2516-2524. doi: 10.1001/jama.295.21.2516 (Pubitemid 43854967)
19. Yan L, Wong S, Wathen L, Chang D, Ni L, Ingram M, Parson M, Rosen L (2005) The pharmacokinetic (PK) effect of AMG 706 on CYP3A activity evaluated by use of oral midazolam as probe in patients with advanced solid tumors [abstract]. J Clin Oncol 23(Suppl 16):3178
20. Rochat B (2005) Role of cytochrome P450 activity in the fate of anticancer agents and in drug resistance: focus on tamoxifen, paclitaxel and imatinib metabolism. Clin Pharmacokinet 44(4):349-366 (Pubitemid 40663682)
21. Scripture CD, Sparreboom A, Figg WD (2005) Modulation of cytochrome P450 activity: implications for cancer therapy. Lancet Oncol 6(10):780-789. doi: 10.1016/S1470-2045(05)70388-0 (Pubitemid 41430719)
22. Patterson SD, Davis MT, Mackey J, Martin M, Hei Y-J, Bass MB (2010) Biomarkers as potential predictors of response to treatment with motesanib or bevacizumab in combination with paclitaxel (P) in patients (Pts) with locally recurrent or advanced metastatic breast cancer [abstract/poster]. J Clin Oncol 28(Suppl 7):1048
23. Bass MB, Davis MT, Kivman L, Khoo H-M, Notari K, Blumenschein GR Jr, Mackey J, Sherman SI, Hei Y-J, Patterson SD (2010) Placental growth factor as a marker of therapeutic response to treatment with motesanib in patients with progressive advanced thyroid cancer, advanced nonsquamous non-small-cell lung cancer, and locally recurrent or advanced metastatic breast cancer [abstract]. J Clin Oncol 28(Suppl 7):3037
24. Scagliotti G, Vynnychenko I, Park K, Ichinose Y, Kubota K, Blackhall F, Pirker R, Galiulin R, Ciuleanu T, Sydorenko O, Dediu M, Papai-Szekely Z, Martinez Banaclocha N, McCoy S, Yao B, Hei YJ, Galimi F, Spigel DR (2012) International, randomized, placebo-controlled, double-blind phase III study of motesanib plus carboplatin/paclitaxel in patients with advanced nonsquamous non-small-cell lung cancer: MONET1. J Clin Oncol. doi: 10.1200/JCO.2011.41.4987
25. Miles DW, Chan A, Dirix LY, Cortes J, Pivot X, Tomczak P, Delozier T, Sohn JH, Provencher L, Puglisi F, Harbeck N, Steger GG, Schneeweiss A, Wardley AM, Chlistalla A, Romieu G (2010) Phase III study of bevacizumab plus docetaxel compared with placebo plus docetaxel for the first-line treatment of human epidermal growth factor receptor 2-negative metastatic breast cancer. J Clin Oncol 28(20):3239-3247. doi: 10.1200/JCO.2008.21.6457
26. Robert NJ, Dieras V, Glaspy J, Brufsky A, Bondarenko I, Lipatov O, Perez E, Yardley D, Chan Y, Zhou X, Phan S, O'Shaughnessy J (2011) RIBBON-1: randomized, double-blind, placebo-controlled, phase III trial of chemotherapy with or without bevacizumab for first-line treatment of human epidermal growth factor receptor 2-negative, locally recurrent or metastatic beast cancer. J Clin Oncol 29(10):1252-1260. doi: 10.1200/JCO.2010.28.0982
27. Martin M, Roche H, Pinter T, Crown J, Kennedy MJ, Provencher L, Priou F, Eiermann W, Adrover E, Lang I, Ramos M, Latreille J, Jagiello-Gruszfeld A, Pienkowski T, Alba E, Snyder R, Almel S, Rolski J, Munoz M, Moroose R, Hurvitz S, Banos A, Adewoye H, Hei YJ, Lindsay MA, Rupin M, Cabaribere D, Lemmerick Y, Mackey JR, TRIO 010 investigators (2011) Motesanib, or open-label bevacizumab, in combination with paclitaxel, as first-line treatment for HER2-negative locally recurrent or metastatic breast cancer: a phase 2, randomised, double-blind, placebo-controlled study. Lancet Oncol 12(4):369-376. doi: 10.1016/S1470-2045(11)70037-7
28. Song S, Ewald AJ, Stallcup W, Werb Z, Bergers G (2005) PDGFRbeta+ perivascular progenitor cells in tumours regulate pericyte differentiation and vascular survival. Nat Cell Biol 7(9):870-879. doi: 10.1038/ncb1288 (Pubitemid 41486287)
29. Dvorak HF (2002) Vascular permeability factor/vascular endothelial growth factor: a critical cytokine in tumor angiogenesis and a potential target for diagnosis and therapy. J Clin Oncol 20(21):4368-4380 (Pubitemid 35266299)
30. Heinrich MC, Blanke CD, Druker BJ, Corless CL (2002) Inhibition of KIT tyrosine kinase activity: a novel molecular approach to the treatment of KIT-positive malignancies. J Clin Oncol 20(6):1692-1703 (Pubitemid 34260552)
31. Su JL, Yang PC, Shih JY, Yang CY, Wei LH, Hsieh CY, Chou CH, Jeng YM, Wang MY, Chang KJ, Hung MC, Kuo ML (2006) The VEGF-C/Flt-4 axis promotes invasion and metastasis of cancer cells. Cancer Cell 9(3):209-223. doi: 10.1016/j.ccr.2006.02.018 (Pubitemid 43357947)