Molife, L. R., Attard, G., Fong, P. C., Karavasilis, V., Reid, A. H. M., Patterson, S., Riggs Jr., C. E., Higano, C., Stadler, W. M., McCulloch, W., Dearnaley, D., Parker, C., de Bono, J. S. (2010) Phase II, two-stage, single-arm trial of the histone deacetylase inhibitor (HDACi) romidepsin in metastatic castration-resistant prostate cancer (CRPC). ANNALS OF ONCOLOGY, 21 (1). pp. 109-113. ISSN 0923-7534

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Abstract

Patients and methods: A dose of 13 mg/m(2) was administered i.v. over 4 h on days 1, 8 and 15 every 28 days. The primary end point was rate of disease control defined as no evidence of radiological progression at 6 months. A sample size of 16 assessable patients in stage 1 and nine assessable patients in stage 2 was selected; progression to stage 2 required one or more patients with disease control in stage 1 (H-o = 0.10, H-a = 0.30; alpha and beta = 0.10). Results: Thirty-five patients were enrolled. Two patients achieved a confirmed radiological partial response (RECIST) lasting >= 6 months, along with a confirmed prostate-specific antigen decline of >= 50%. Eleven patients experienced toxicity necessitating early discontinuation. The commonest adverse events were nausea (30 patients; 85.7%), fatigue (28 patients; 80.0%), vomiting (23 patients; 65.7%) and anorexia (20 patients; 57.1%). There was no significant cardiac toxicity. Conclusions: At the dose and schedule selected, romidepsin demonstrated minimal antitumor activity in chemonaive patients with CRPC. Further studies of improved HDACi, alone and in combination with other therapies, should nevertheless be investigated.

Item Type:	Article
Authors (ICR Faculty only):	De-Bono, Johann and Dearnaley, David and Parker, Chris
All Authors:	Molife, L. R., Attard, G., Fong, P. C., Karavasilis, V., Reid, A. H. M., Patterson, S., Riggs Jr., C. E., Higano, C., Stadler, W. M., McCulloch, W., Dearnaley, D., Parker, C., de Bono, J. S.
Uncontrolled Keywords:	histone deacetylase; phase II; prostate cancer; romidepsin;ADVANCED SOLID TUMORS; CLINICAL-TRIALS; DEPSIPEPTIDE FR901228; WORKING GROUP; RECEPTOR; HSP90; RECOMMENDATIONS; MITOXANTRONE; PREDNISONE; EXPRESSION
Funding Acknowledgement:	Gloucester Pharmaceuticals
Funding Text:	This study was sponsored by Gloucester Pharmaceuticals.
Research teams:	ICR divisions > Cancer Therapeutics > Cancer Biomarkers ICR divisions > Clinical Studies > Cancer Biomarkers ICR divisions > Radiotherapy and Imaging > Clinical Academic Radiotherapy (Dearnaley) Closed research groups > Clinical Academic Radiotherapy (Dr C Parker) ICR divisions > Clinical Studies > Prostate Cancer Targeted Therapy Group
Depositing User:	Users 10 not found.
Date Deposited:	08 Jan 2010 13:16
Last Modified:	11 Jul 2017 12:48
URI:	http://publications.icr.ac.uk/id/eprint/9211

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