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A phase II study of depsipeptide in refractory metastatic renal cell cancer.

Abstract：

BACKGROUND:Therapeutic options for renal cell cancer are inadequate. Depsipeptide is a histone deacetylase inhibitor with promising preclinical and early clinical activity. PATIENTS AND METHODS:Patients with refractory renal cell cancer with normal organ function and no history of significant cardiovascular disease were enrolled on a multi-institutional, single-arm, phase II study. Patients received depsipeptide 13 mg/m2 intravenously over 4 hours on days 1, 8, and 15 of a 28-day cycle with disease reevaluation performed every 8 weeks. One response in the initial 16 enrolled patients was required for full accrual to 25 patients, from which 5 responses needed to be observed in order to consider the agent appropriate for further study. Toxicity was assessed using National Cancer Institute Common Toxicity Criteria, version 2.0. RESULTS:The 29 evaluable patients, who were accrued so that 25 patients who received >or= 3 doses of depsipeptide could be observed, were heavily pretreated with a median of 2 previous systemic therapies and a 2-year median duration of metastatic disease. Twenty-four had clear-cell histology. The most common serious toxicities were fatigue, nausea, vomiting, and anemia. Two patients developed a prolonged QTc interval, one patient each developed grade 3 atrial fibrillation and tachycardia, and there was 1 sudden death. Two patients experienced an objective response (1 complete response) for an overall response rate of 7% (95% CI, 0.8%-23%). CONCLUSION:Depsipeptide at this dose and schedule does not have sufficient activity for further investigation in this patient population.

journal_name

Clin Genitourin Cancer

journal_title

Clinical genitourinary cancer

authors

Stadler WM,Margolin K,Ferber S,McCulloch W,Thompson JA

doi

10.3816/CGC.2006.n.018

subject

Has Abstract

pub_date

2006-06-01 00:00:00

pages

57-60

issue

1

eissn

1558-7673

issn

1938-0682

pii

S1558-7673(11)70153-7

journal_volume

5

pub_type

杂志文章,多中心研究

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