Phase I study of vorinostat in patients with advanced solid tumors and hepatic dysfunction: A National Cancer Institute Organ Dysfunction Working Group study

Journal of Clinical Oncology

Volumn 28, Issue 29, 2010, Pages 4507-4512

  Ramalingam, Suresh S ^a   Kummar, Shivaani ^a   Sarantopoulos, John ^a   Shibata, Stephen ^a   LoRusso, Patricia ^a   Yerk, Mara ^a   Holleran, Julianne ^a   Lin, Yan ^a   Beumer, Jan H ^a   Harvey, R Donald ^a   Ivy, S Percy ^a   Belani, Chandra P ^a   Egorin, Merrill J ^a  

^a NONE

Author keywords

[No Author keywords available]

Indexed keywords

VORINOSTAT;

ADENOID CYSTIC CARCINOMA; ADULT; ANEMIA; ANOREXIA; ANTINEOPLASTIC ACTIVITY; AREA UNDER THE CURVE; ARTICLE; BILE DUCT CARCINOMA; BONE MARROW; BREAST CANCER; COLON CANCER; CONTROLLED STUDY; DEHYDRATION; DIARRHEA; DRUG BLOOD LEVEL; DRUG DOSE ESCALATION; DRUG EFFICACY; DRUG HALF LIFE; DRUG RESPONSE; FATIGUE; FEMALE; HUMAN; HYPERBILIRUBINEMIA; KIDNEY FUNCTION; LEUKOPENIA; LIQUID CHROMATOGRAPHY; LIVER CELL CARCINOMA; LIVER DYSFUNCTION; LUNG CANCER; LYMPHOCYTOPENIA; MAJOR CLINICAL STUDY; MALE; MAXIMUM TOLERATED DOSE; NAUSEA; NEUTROPENIA; PANCREAS CANCER; PHASE 1 CLINICAL TRIAL; PRIMARY TUMOR; PRIORITY JOURNAL; RECTUM CANCER; SINGLE DRUG DOSE; SOLID TUMOR; TANDEM MASS SPECTROMETRY; THROMBOCYTOPENIA; THYMUS CANCER; THYROID CARCINOMA; TUMOR GROWTH;

ANOREXIA; ANTINEOPLASTIC AGENTS; AREA UNDER CURVE; DIARRHEA; DOSE-RESPONSE RELATIONSHIP, DRUG; FATIGUE; FEMALE; HUMANS; HYDROXAMIC ACIDS; LIVER; MALE; METABOLIC CLEARANCE RATE; MIDDLE AGED; NATIONAL CANCER INSTITUTE (U.S.); NEOPLASMS; THROMBOCYTOPENIA; TREATMENT OUTCOME; UNITED STATES;

EID: 79951910702     PISSN: 0732183X     EISSN: 15277755     Source Type: Journal    
DOI: 10.1200/JCO.2010.30.2307     Document Type: Article

References (26)

1. Dokmanovic M, Clarke C, Marks PA: Histone deacetylase inhibitors: Overview and perspectives. Mol Cancer Res 5:981-989, 2007 (Pubitemid 350080267)
2. Marks PA, Richon VM, Breslow R, et al: Histone deacetylase inhibitors as new cancer drugs. Curr Opin Oncol 13:477-483, 2001 (Pubitemid 33027900)
3. Neuzil J, Swettenham E, Gellert N: Sensitization of mesothelioma to TRAIL apoptosis by inhibition of histone deacetylase: Role of Bcl-xL down-regulation. Biochem Biophys Res Commun 314:186-191, 2004 (Pubitemid 38058387)
4. Marks P, Rifkind RA, Richon VM, et al: Histone deacetylases and cancer: Causes and therapies. Nat Rev Cancer 1:194-202, 2001 (Pubitemid 33741894)
5. Richon VM, Webb Y, Merger R, et al: Second generation hybrid polar compounds are potent inducers of transformed cell differentiation. Proc Natl Acad Sci U S A 93:5705-5708, 1996 (Pubitemid 26191313)
6. Yu C, Rahmani M, Almenara J, et al: Histone deacetylase inhibitors promote STI571-mediated apoptosis in STI571-sensitive and -resistant Bcr/Abl+ human myeloid leukemia cells. Cancer Res 63:2118-2126, 2003 (Pubitemid 36538615)
7. Kim MS, Kwon HJ, Lee YM, et al: Histone deacetylases induce angiogenesis by negative regulation of tumor suppressor genes. Nat Med 7:437-443, 2001 (Pubitemid 32298546)
8. Duvic M, Talpur R, Ni X, et al: Phase 2 trial of oral vorinostat (suberoylanilide hydroxamic acid, SAHA) for refractory cutaneous T-cell lymphoma (CTCL). Blood 109:31-39, 2007
9. Kelly WK, O'Connor OA, Krug LM, et al: Phase I study of an oral histone deacetylase inhibitor, suberoylanilide hydroxamic acid, in patients with advanced cancer. J Clin Oncol 23:3923-3931, 2005 (Pubitemid 46218695)
10. Ramalingam SS, Parise RA, Ramanathan RK, et al: Phase I and pharmacokinetic study of vorinostat, a histone deacetylase inhibitor, in combination with carboplatin and paclitaxel for advanced solid malignancies. Clin Cancer Res 13:3605-3610, 2007 (Pubitemid 46955122)
11. Witta SE, Gemmill RM, Hirsch FR, et al: Restoring E-cadherin expression increases sensitivity to epidermal growth factor receptor inhibitors in lung cancer cell lines. Cancer Res 66:944-950, 2006 (Pubitemid 43165962)
12. Fakih MG, Pendyala L, Fetterly G, et al: A phase I, pharmacokinetic and pharmacodynamic study on vorinostat in combination with 5-fluorouracil, leucovorin, and oxaliplatin in patients with refractory colorectal cancer. Clin Cancer Res 15:3189-3195, 2009
13. Parise RA, Holleran JL, Beumer JH, et al: A liquid chromatography- electrospray ionization tandem mass spectrometric assay for quantitation of the histone deacetylase inhibitor, vorinostat (suberoylanilide hydroxamicacid, SAHA), and its metabolites in human serum. J Chromatogr B Analyt Technol Biomed Life Sci 840:108-115, 2006 (Pubitemid 44163473)
14. Kelly WK, Richon VM, O'Connor O, et al: Phase I clinical trial of histone deacetylase inhibitor: Suberoylanilide hydroxamic acid administered intravenously. Clin Cancer Res 9:3578-3588, 2003 (Pubitemid 37169221)
15. Yeh KC, Kwan KC: A comparison of numerical integrating algorithms by trapezoidal, LaGrange, and spline approximation. J Pharmacokinet Biopharm 6:79-98, 1978 (Pubitemid 8314204)
16. Rocci ML Jr, Jusko WJ: LAGRAN program for area and moments in pharmacokinetic analysis. Comput Programs Biomed 16:203-216, 1983
17. Fujiwara Y, Yamamoto N, Yamada Y, et al: Phase I and pharmacokinetic study of vorinostat (suberoylanilide hydroxamic acid) in Japanese patients with solid tumors. Cancer Sci 100:1728-1734, 2009
18. Rubin EH, Agrawal NG, Friedman EJ, et al: A study to determine the effects of food and multiple dosing on the pharmacokinetics of vorinostat given orally to patients with advanced cancer. Clin Cancer Res 12:7039-7045, 2006 (Pubitemid 44974501)
19. Gibbons J, Egorin MJ, Ramanathan RK, et al: Phase I and pharmacokinetic study of imatinib mesylate in patients with advanced malignancies and varying degrees of renal dysfunction: A study by the National Cancer Institute Organ Dysfunction Working Group. J Clin Oncol 26:570-576, 2008 (Pubitemid 351264350)
20. Ramanathan RK, Egorin MJ, Takimoto CH, et al: Phase I and pharmacokinetic study of imatinib mesylate in patients with advanced malignancies and varying degrees of liver dysfunction: A study by the National Cancer Institute Organ Dysfunction Working Group. J Clin Oncol 26:563-569, 2008 (Pubitemid 351264349)
21. Takimoto CH, Graham MA, Lockwood G, et al: Oxaliplatin pharmacokinetics and pharmacodynamics in adult cancer patients with impaired renal function. Clin Cancer Res 13:4832-4839, 2007 (Pubitemid 47294791)
22. Mulkerin D, Remick SC, Ramananthan RK, et al: A dose-escalating and pharmacologic study of bortezomib in adult cancer patients with impaired renal function. J Clin Oncol 24:87s, 2006 (suppl; abstr 2032)
23. Miller AA, Murry DJ, Owzar K, et al: Phase I and pharmacokinetic study of sorafenib in patients with hepatic or renal dysfunction: CALGB 60301. J Clin Oncol 27:1800-1805, 2009
24. Blumenschein GR Jr, Kies MS, Papadimitrakopoulou VA, et al: Phase II trial of the histone deacetylase inhibitor vorinostat (Zolinza, suberoylanilide hydroxamic acid, SAHA) in patients with recurrent and/or metastatic head and neck cancer. Invest New Drugs 26:81-87, 2008
25. Luu TH, Morgan RJ, Leong L, et al: A phase II trial of vorinostat (suberoylanilide hydroxamic acid) in metastatic breast cancer: A California Cancer Consortium study. Clin Cancer Res 14:7138-7142, 2008
26. Traynor AM, Dubey S, Eickhoff JC, et al: Vorinostat (NSC# 701852) in patients with relapsed non-small cell lung cancer: A Wisconsin Oncology Network phase II study. J Thorac Oncol 4:522-526, 2009