| Abstract | PURPOSE: This multi-institutional phase II trial assessed the activity and toxicity of a new histone deacetylase inhibitor, vorinostat (suberoylanilide hydroxamic acid--SAHA) in patients with recurrent or persistent epithelial ovarian or primary peritoneal carcinoma. PATIENTS AND METHODS: Women with recurrent or persistent epithelial ovarian or primary peritoneal carcinoma who were platinum-resistant/refractory (progression-free interval <12 months since platinum) were eligible for trial entry if they had measurable disease, a good performance status, and good overall organ function. Women were treated with a 400 mg daily oral dose of vorinostat and continued on treatment until disease progression or unacceptable toxicity. The primary endpoints were progression-free survival (PFS) at 6 months and toxicity. Secondary endpoints were tumor response, duration of PFS and duration of overall survival (OS). RESULTS: Twenty-seven women were enrolled through the Gynecologic Oncology Group (GOG) on the planned first stage of accrual for this trial and were eligible for analysis. Two women survived progression-free over 6 months, with one having a partial response. Two grade 4 toxicities were reported (one leukopenia and one neutropenia). The most common grade 3 toxicities were constitutional (3/27; 11%) and gastrointestinal (3/27, 11%). Other grade 3 toxicities included neutropenia, metabolic abnormalities, and thrombocytopenia (two patients each, 7%) as well as neurologic complaints and pain (1 patient each; 4%). CONCLUSION: Vorinostat is well tolerated but had minimal activity as a single agent in unscreened patients with recurrent platinum-refractory ovarian or primary peritoneal carcinoma. |
| Authors | Susan C Modesitt, Michael Sill, James S Hoffman, David P Bender, Gynecologic Oncology Group
(Affiliation: University of Virginia Health System, Charlottesville, VA 22908, USA. scm6h at virginia.edu)
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| Journal | Gynecologic oncology
(Gynecol Oncol)
Vol. 109
Issue 2
Pg. 182-6
(May 2008)
ISSN: 1095-6859 United States |
| PMID | 18295319
(Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Research Support, N.I.H., Extramural)
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| Chemical References |
- Antineoplastic Agents
- Hydroxamic Acids
- vorinostat
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| Topics |
- Adult
- Aged
- Aged, 80 and over
- Antineoplastic Agents
(adverse effects, therapeutic use)
- Carcinoma
(drug therapy, physiopathology)
- Disease-Free Survival
- Female
- Gastrointestinal Diseases
(chemically induced)
- Hematologic Diseases
(chemically induced)
- Humans
- Hydroxamic Acids
(adverse effects, therapeutic use)
- Kaplan-Meiers Estimate
- Middle Aged
- Neoplasm Recurrence, Local
(drug therapy, physiopathology)
- Nervous System Diseases
(chemically induced)
- Ovarian Neoplasms
(drug therapy, physiopathology)
- Peritoneal Neoplasms
(drug therapy, physiopathology)
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