A dose-ranging study of cabozantinib in men with castration-resistant prostate cancer and bone metastases

Clinical Cancer Research

Volumn 19, Issue 11, 2013, Pages 3088-3094

  Lee, Richard J ^a   Saylor, Philip J ^a   Michaelson, M Dror ^a   Rothenberg, S Michael ^a   Smas, Malgorzata E ^a   Miyamoto, David T ^a   Gurski, Carol A ^a   Xie, Wanling ^b   Maheswaran, Shyamala ^a   Haber, Daniel A ^a   Goldin, Jonathan G ^c   Smith, Matthew R ^a  

^a MASSACHUSETTS GENERAL HOSPITAL CANCER CENTER   (United States)

^b DANA FARBER CANCER INSTITUTE   (United States)

^c UNIVERSITY OF CALIFORNIA   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CABOZANTINIB; PROSTATE STEM CELL ANTIGEN;

ADULT; AGED; ANOREXIA; ARTICLE; BONE METASTASIS; BONE SCINTISCANNING; CASTRATION RESISTANT PROSTATE CANCER; CIRCULATING TUMOR CELL; CLINICAL ARTICLE; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIARRHEA; DOSE RESPONSE; DRUG DOSE COMPARISON; DRUG DOSE ESCALATION; DRUG EFFICACY; DRUG TOLERABILITY; DRUG WITHDRAWAL; FATIGUE; FEVER; HUMAN; INFECTION; LOW DRUG DOSE; MALE; NEUTROPENIA; PRIORITY JOURNAL; PROTEIN BLOOD LEVEL; SIDE EFFECT; TREATMENT DURATION; VENOUS THROMBOEMBOLISM; WEIGHT REDUCTION;

AGED; AGED, 80 AND OVER; ANILIDES; ANTINEOPLASTIC AGENTS; BONE NEOPLASMS; COHORT STUDIES; HUMANS; MALE; MIDDLE AGED; NEOPLASTIC CELLS, CIRCULATING; ORCHIECTOMY; PROSTATE-SPECIFIC ANTIGEN; PROSTATIC NEOPLASMS; PROTEIN KINASE INHIBITORS; PYRIDINES; TREATMENT OUTCOME;

EID: 84878961883     PISSN: 10780432     EISSN: 15573265     Source Type: Journal    
DOI: 10.1158/1078-0432.CCR-13-0319     Document Type: Article

References (26)

1. Saylor PJ, Lee RJ, Smith MR. Emerging therapies to prevent skeletal morbidity in men with prostate cancer. J Clin Oncol 2011;29:3705-14.
2. Norgaard M, Jensen AO, Jacobsen JB, Cetin K, Fryzek JP, Sorensen HT. Skeletal related events, bone metastasis and survival of prostate cancer: a population based cohort study in Denmark (1999 to 2007). J Urol 2010;184:162-7.
3. Humphrey PA, Zhu X, Swanson PE, Ratliff TL, Vollmer RT, Day ML. Hepatocyte growth factor and its receptor (c-MET) in prostatic carcinoma. Am J Pathol 1995;147:386-96.
4. Verras M, Lee J, Xue H, Li T-H, Wang Y, Sun Z. The androgen receptor negatively regulates the expression of c-Met: implications for a novel mechanism of prostate cancer progression. Cancer Res 2007;67:967-75.
5. Knudsen BS, Gmyrek GA, Inra J, Scherr DS, Vaughan ED, Nanus DM, et al. High expression of the Met receptor in prostate cancer metastasis to bone. Urology 2002;60:1113-7. (Pubitemid 35447590)
6. Bok RA, Halabi S, Fei DT, Rodriquez CR, Hayes DF, Vogelzang NJ, et al. Vascular endothelial growth factor and basic fibroblast growth factor urine levels as predictors of outcome in hormone-refractory prostate cancer patients: a Cancer And Leukemia Group B (CALGB) study. Cancer Res 2001;61:2533-6. (Pubitemid 32685834)
7. George DJ, Halabi S, Shepard TF, Sanford B, Vogelzang NJ, Small EJ, et al. The prognostic significance of plasma interleukin-6 levels in patients with metastatic hormone-refractory prostate cancer: results from Cancer And Leukemia Group B (CALGB) 9480. Clin Cancer Res 2005;11:1815-20. (Pubitemid 40471844)
8. Grano M, Galimi F, Zambonin G, Colucci S, Cottone E, Zallone AZ, et al. Hepatocyte growth factor is a coupling factor for osteoclasts and osteoblasts in vitro. Proc Natl Acad Sci USA 1996;93:7644-8. (Pubitemid 26277090)
9. Zhang S, Zhau H, Osunkoya A, Iqbal S, Yang X, Fan S, et al. Vascular endothelial growth factor regulates myeloid cell leukemia-1 expression through neuropilin-1-dependent activation of c-MET signaling in human prostate cancer cells. Mol Cancer 2010;9:9.
10. Yakes FM, Chen J, Tan J, Yamaguchi K, Shi Y, Yu P, et al. Cabozantinib (XL184), a novel MET and VEGFR2 inhibitor, simultaneously suppresses metastasis, angiogenesis, and tumor growth. Mol Cancer Ther 2011;10:2298-308.
11. Schoffski P, Elisei R, Muller S, Brose MS, Shah MH, Licitra LF, et al. An international, double-blind, randomized, placebo-controlled phase III trial (EXAM) of cabozantinib (XL184) in medullary thyroid carcinoma (MTC) patients (pts) with documented RECIST progression at baseline. J Clin Oncol 2012 (suppl; abstr 5508).
12. Smith DC, Smith MR, Sweeney C, Elfiky AA, Logothetis C, Corn PG, et al. Cabozantinib in patients with advanced prostate cancer: results of a phase II randomized discontinuation trial. J Clin Oncol 2013;31:412-9.
13. Scher HI, Halabi S, Tannock I, Morris M, Sternberg CN, Carducci MA, et al. Design and end points of clinical trials for patients with progressive prostate cancer and castrate levels of testosterone: recommendations of the Prostate Cancer Clinical Trials Working Group. J Clin Oncol 2008;26:1148-59.
14. Chu GH, Brown MS, Kim HJ, Auerbach M, Poon C, Ramakrishna B, et al. Initial analytic validation of automated bone scan measures for treatment response assessment in patients with metastatic castration-resistant prostate cancer (CRPC). J Clin Oncol 29:2011 (suppl; abstr e15174).
15. Brown MS, Chu GH, Kim HJ, Allen-Auerbach M, Poon C, Bridges J, et al. Computer-aided quantitative bone scan assessment of prostate cancer treatment response. Nucl Med Commun 2012;33:384-94.
16. de Bono JS, Scher HI, Montgomery RB, Parker C, Miller MC, Tissing H, et al. Circulating tumor cells predict survival benefit from treatment in metastatic castration-resistant prostate cancer. Clin Cancer Res 2008;14:6302-9.
17. Sargent DJ, Chan V, Goldberg RM. A three-outcome design for phase II clinical trials. Control Clin Trials 2001;22:117-25. (Pubitemid 32289448)
18. Olmos D, Arkenau HT, Ang JE, Ledaki I, Attard G, Carden CP, et al. Circulating tumour cell (CTC) counts as intermediate end points in castration-resistant prostate cancer (CRPC): a single-centre experience. Ann Oncol 2009;20:27-33.
19. Smith MR, Sweeney C, Rathkopf DE, Scher HI, Logothetis C, George DJ, et al. Cabozantinib (XL184) in chemotherapy-pretreated metastatic castration resistant prostate cancer (mCRPC): Results from a phase II nonrandomized expansion cohort (NRE). J Clin Oncol 30;2012 (suppl; abstr 4513).
20. Kurzrock R, Sherman SI, Ball DW, Forastiere AA, Cohen RB, Mehra R, et al. Activity of XL184 (Cabozantinib), an oral tyrosine kinase inhibitor, in patients with medullary thyroid cancer. J Clin Oncol 2011;29:2660-6.
21. Michaelson MD, Regan MM, Oh WK, Kaufman DS, Olivier K, Michaelson SZ, et al. Phase II study of sunitinib in men with advanced prostate cancer. Ann Oncol 2009;20:913-20.
22. Saylor PJ, Mahmood U, Kunawudhi A, Smith MR, Palmer EL, Michaelson MD. Multitargeted tyrosine kinase inhibition produces discordant changes between 99mTc-MDP bone scans and other disease biomarkers: analysis of a phase II study of sunitinib for metastatic castration-resistant prostate cancer. J Nucl Med 2012;53:1670-5.
23. Kelly WK, Halabi S, Carducci M, George D, Mahoney JF, Stadler WM, et al. Randomized, double-blind, placebo-controlled phase III trial comparing docetaxel and prednisone with or without bevacizumab in men with metastatic castration-resistant prostate cancer: CALGB 90401. J Clin Oncol 2012;30:1534-40.
24. Michaelson MD, Oudard S, Ou Y, Sengelov F, Saad F, Houede N, et al. Randomized, placebo-controlled, phase III trial of sunitinib in combination with prednisone (SU+P) versus prednisone (P) alone inmen with progressive metastatic castration-resistant prostate cancer (mCRPC). J Clin Oncol 29;2011 (suppl; abstr 4515).
25. Petrylak DP, Fizazi K, Sternberg CN, Budnik N, Wit Rd, Wiechno PJ, et al. A phase 3 study to evaluate the efficacy and safety of docetaxel and prednisone (DP) with or without lenalidomide in patients with castrate-resistant prostate cancer (CRPC): the MAINSAIL Trial. ESMO 2012. Abstract nr LBA24.
26. Ryan CJ, Rosenthal M, Ng S, Alumkal J, Picus J, Gravis G, et al. Targeted MET inhibition in castration-resistant prostate cancer: a randomized phase II study and biomarker analysis with rilotumumab plus mitoxantrone and prednisone. Clin Cancer Res 2013;19:215-24.