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A phase II study of depsipeptide in refractory metastatic renal cell cancer
Walter M Stadler1, Kim Margolin, Sandy Ferber
1Department of Medicine, University of Chicago, IL 60637-1470, USA. wstadler@medicine.bsd.uchicago.edu
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.
Insights
Depsipeptide showed limited efficacy in patients with advanced renal cell cancer. The histone deacetylase inhibitor did not demonstrate sufficient activity for further study in this population.
Area of Science:
- Oncology
- Pharmacology
Background:
- Renal cell cancer (RCC) presents limited therapeutic options.
- Depsipeptide, a histone deacetylase inhibitor, exhibits preclinical and early clinical promise.
Purpose of the Study:
- To evaluate the efficacy and safety of depsipeptide in patients with refractory renal cell cancer.
Main Methods:
- A multi-institutional, single-arm, phase II study enrolled patients with refractory RCC.
- Depsipeptide was administered intravenously at 13 mg/m2 on days 1, 8, and 15 of a 28-day cycle.
- Toxicity was assessed using National Cancer Institute Common Toxicity Criteria, version 2.0.
Main Results:
- Twenty-nine evaluable patients, heavily pretreated, received depsipeptide.
- The overall response rate was 7% (1 complete response, 1 partial response).
- Common toxicities included fatigue, nausea, vomiting, and anemia; cardiac events were also noted.
Conclusions:
- Depsipeptide at the studied dose and schedule lacks sufficient activity for further investigation in this patient population.
- The agent is not recommended for further study in advanced renal cell cancer.
