A phase II study of ZD6474 (Zactima™), a selective inhibitor of VEGFR and EGFR tyrosine kinase in patients with relapsed multiple myeloma - NCIC CTG IND.145

Investigational New Drugs

Volumn 24, Issue 6, 2006, Pages 529-535

  Kovacs, Michael J ^a,c   Reece, Donna E ^a   Marcellus, Deborah ^a   Meyer, Ralph M ^a   Mathews, Sarah ^a   Dong, Rui Ping ^b   Eisenhauer, Elizabeth ^a  

^a Queen's Cancer Research Institute   (Canada)

^b ASTRAZENECA   (United Kingdom)

^c LONDON HEALTH SCIENCES CENTRE   (Canada)

Author keywords

Multiple myeloma; Treatment; VEGF receptor; ZD6474

Indexed keywords

ALANINE AMINOTRANSFERASE; ASPARTATE AMINOTRANSFERASE; BILIRUBIN; CREATININE; EPIDERMAL GROWTH FACTOR RECEPTOR KINASE INHIBITOR; M PROTEIN; VANDETANIB; VASCULOTROPIN RECEPTOR;

ABNORMALLY HIGH SUBSTRATE CONCENTRATION IN BLOOD; ADULT; AGED; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ANGIOGENESIS; ANOREXIA; ARTHRALGIA; ARTICLE; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; BILIRUBIN BLOOD LEVEL; CANCER PATIENT; CANCER RELAPSE; CHEMOTHERAPY INDUCED EMESIS; CLINICAL ARTICLE; CLINICAL TRIAL; CONSTIPATION; CREATININE BLOOD LEVEL; DESQUAMATION; DIARRHEA; DISEASE SEVERITY; DIZZINESS; DOSE RESPONSE; DRUG BLOOD LEVEL; DRUG EFFICACY; DRUG SELECTIVITY; DRUG TOLERABILITY; DYSPNEA; EYE TOXICITY; FATIGUE; FEMALE; FLU LIKE SYNDROME; HEADACHE; HEARING DISORDER; HOT FLUSH; HUMAN; HYPERTENSION; MALE; MULTIPLE MYELOMA; NAUSEA; PHASE 2 CLINICAL TRIAL; PHOTOSENSITIVITY; PRIORITY JOURNAL; PRURITUS; QT INTERVAL; RASH; SENSORY NEUROPATHY; SIGNAL TRANSDUCTION; STOMATITIS; TASTE DISORDER; THORAX PAIN; TREATMENT RESPONSE; TREMOR; XEROSTOMIA;

EID: 33747644424     PISSN: 01676997     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (25)

1. Riedel DA, Pottern LM (1992) The epidemiology of multiple myeloma. Hematol Oncol Clin North Am 6:225-247
2. Bergsagel DE (1995) The role of chemotherapy in the treatment of multiple myeloma. Baillieres Clin Haematol 8:783-794
3. Berenson JR, Rosen L, Vescio R, Lau HS, Woo M, Sioufi A, Kowalski MO, Knight RD, Seaman JJ (1997) Pharmacokinetics of pamidronate disodium in patients with cancer with normal or impaired renal function. J Clin Pharmacol 37:285-290
4. Berenson JR, Lichtenstein A, Porter L, Dimopoulos MA, Bordoni R, George S, Lipton A, Keller A, Ballester O, Kovacs MJ, Blacklock HA, Bell R, Simeone J, Reitsma DJ, Heffernan M, Seaman J, Knight RD (1996) Efficacy of pamidronate in reducing skeletal events in patients with advanced multiple myeloma. Myeloma Aredia Study Group. N Engl J Med 334:488-493
5. Singhal S, Mehta J, Desikan R, Ayers D, Roberson P, Eddlemon P, Munshi N, Anaissie E, Wilson C, Dhodapkar M, Zeddis J, Barlogie B (1999) Antitumor activity of thalidomide in refractory multiple myeloma. N Engl J Med 341:1565-1571
6. Richardson PG, Barlogie B, Berenson J, Singhal S, Jagannath S, Irwin D, Rajkumar SV, Srkalovic G, Alsina M, Alexanian R, Siegel D, Orlowski RZ, Kuter D, Limentani SA, Lee S, Hideshima T, Esseltine DL, Kauffman M, Adams J, Schenkein DP, Anderson KC (2003) A phase 2 study of bortezomib in relapsed, refractory myeloma. N Engl J Med 348:2609-2617
7. Attal M, Harousseau JL, Stoppa AM, Sotto JJ, Fuzibet JG, Rossi JF, Casassus P,Maisonneuve H, Facon T, Ifrah N, Payen C, Bataille R (1996) A prospective, randomized trial of autologous bone marrow transplantation and chemotherapy in multiple myeloma. Intergroupe Francais du Myelome. N Engl J Med 335:91-97
8. Attal M, Harousseau JL, Facon T, Guilhot F, Doyen C, Fuzibet JG, Monconduit M, Hulin C, Caillot D, Bouabdallah R, Voillat L, Sotto JJ, Grosbois B, Bataille R (2003) Single versus double autologous stem-cell transplantation for multiple myeloma. N Engl J Med 349:2495-2502
9. Child JA, Morgan GJ, Davies FE, Owen RG, Bell SE, Hawkins K, Brown J, Drayson MT, Selby PJ (2003) High-dose chemotherapy with hematopoietic stem-cell rescue for multiple myeloma. N Engl J Med 348:1875-1883
10. Vacca A, Ribatti D, Presta M, Minischetti M, Iurlaro M, Ria R, Albini A, Bussolino F, Dammacco F (1999) Bone marrow neovascularization, plasma cell angiogenic potential, and matrix metalloproteinase-2 secretion parallel progression of human multiple myeloma. Blood 93:3064-3073
11. Vacca A, Di Loreto M, Ribatti D, Di Stefano R,Gadaleta-Caldarola G, Iodice G, Caloro D, Dammacco F (1995) Bone marrow of patients with active multiple myeloma: angiogenesis and plasma cell adhesion molecules LFA-1, VLA-4, LAM-1, and CD44. Am J Hematol 50:9-14
12. Jourdan M, Tarte K, Legouffe E, Brochier J, Rossi JF, Klein B (1999) Tumor necrosis factor is a survival and proliferation factor for human myeloma cells. Eur Cytokine Netw 10:65-70
13. Wedge SR, Ogilvie DJ, Dukes M, Kendrew J, Chester R, Jackson JA, Boffey SJ, Valentine PJ, Curwen JO, Musgrove HL, Graham GA, Hughes GD, Thomas AP, Stokes ES, Curry B, Richmond GH, Wadsworth PF, Bigley AL, Hennequin LF (2002) ZD6474 inhibits vascular endothelial growth factor signaling, angiogenesis, and tumor growth following oral administration. Cancer Res 62:4645-4655
14. Checkley D, Tessier JJ, Kendrew J, Waterton JC, Wedge SR (2003) Use of dynamic contrast-enhanced MRI to evaluate acute treatment with ZD6474, a VEGF signalling inhibitor, in PC-3 prostate tumours. Br J Cancer 89:1889-1895
15. Hurwitz HI, Holden SN, Eckhard SC, Rosenthal M, de Boer R, Rischin D, Green M, Basser R (2002) Clinical evaluation of ZD6474, an orally active inhibitor of VEGF signaling in patients with solid tumors. Proc AM Soc Clinical Oncol 21
16. Minami H, Ebi H, Tahara M, Sasaki Y, Yamamoto N, Yamada Y, Tamura T, Saijo N (2002) A phase I study of an oral VEGF receptor tyrosine kinase inhibitor ZD6474, in Japanese patients with solid tumors. Proc AM Soc Clinical Oncol 21:82a
17. Fleming TR (1982) One-sample multiple testing procedure for phase II clinical trials. Biometrics 38:143-151
18. Barlogie B, Desikan R, Eddlemon P, Spencer T, Zeldis J, Munshi N, Badros A, Zangari M, Anaissie E, Epstein J, Shaughnessy J, Ayers D, Spoon D, Tricot G (2001) Extended survival in advanced and refractory multiple myeloma after single-agent thalidomide: identification of prognostic factors in a phase 2 study of 169 patients. Blood 98:492-494
19. Neben K, Moehler T, Kraemer A, Benner A, Egerer G, Ho AD, Goldschmidt H (2001) Response to thalidomide in progressive multiple myeloma is not mediated by inhibition of angiogenic cytokine secretion. Br J Haematol 115:605-608
20. Hideshima T, Chauhan D, Shima Y, Raje N, Davies FE, Tai YT, Treon SP, Lin B, Schlossman RL, Richardson P, Muller G, Stirling DI, Anderson KC (2000) Thalidomide and its analogs overcome drug resistance of human multiple myeloma cells to conventional therapy. Blood 96:2943-2950
21. Dredge K, Marriott JB, Dalgleish AG (2002) Immunological effects of thalidomide and its chemical and functional analogs. Crit Rev Immunol 22:425-437
22. Davies FE, Raje N, Hideshima T, Lentzsch S, Young G, Tai YT, Lin B, Podar K, Gupta D, Chauhan D, Treon SP, Richardson PG, Schlossman RL, Morgan GJ, Muller GW, Stirling DI, Anderson KC (2001) Thalidomide and immunomodulatory derivatives augment natural killer cell cytotoxicity in multiple myeloma. Blood 98:210-216
23. Gupta D, Treon SP, Shima Y, Hideshima T, Podar K, Tai YT, Lin B, Lentzsch S, Davies FE, Chauhan D, Schlossman RL, Richardson P, Ralph P, Wu L, Payvandi F, Muller G, Stirling DI, Anderson KC (2001) Adherence of multiple myeloma cells to bone marrow stromal cells upregulates vascular endothelial growth factor secretion: therapeutic applications. Leukemia 15:1950-1961
24. Mitsiades N, Mitsiades CS, Poulaki V, Chauhan D, Richardson PG, Hideshima T, Munshi NC, Treon SP, Anderson KC (2002) Apoptotic signaling induced by immunomodulatory thalidomide analogs in human multiple myeloma cells: therapeutic implications. Blood 99:4525-4530
25. Zangari M, Anaissie E, Stopeck A, Morimoto A, Tan N, Lancet J, Cooper M, Hannah A, Garcia-Manero G, Faderl S, Kantarjian H, Cherrington J, Albitar M, Giles FJ (2004) Phase II study of SU5416, a small molecule vascular endothelial growth factor tyrosine kinase receptor inhibitor, in patients with refractory multiple myeloma. Clin Cancer Res 10:88-95