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RATIONALE: Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving vorinostat together with paclitaxel and carboplatin may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of vorinostat when given together with paclitaxel and carboplatin in treating patients with advanced or refractory solid tumors.
- Determine the recommended phase II dose of vorinostat (SAHA) when administered with paclitaxel and carboplatin in patients with advanced or refractory solid tumors.
- Determine the dose-limiting toxicity (DLT) and other toxic effects of this regimen in these patients.
- Assess, preliminarily, evidence of antitumor activity of this regimen in these patients.
- Determine the pharmacokinetic parameters of this regimen in these patients.
- Determine the in vivo effects of this regimen in these patients.
OUTLINE: This is a multicenter, dose-escalation study of vorinostat (SAHA).
Patients receive oral SAHA once or twice daily on days 1-14* and paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who have stable disease after the completion of 6 courses may receive single-agent SAHA at the discretion of the treating physician.
NOTE: *During the first treatment course only, patients receive SAHA on days -4 to 10.
Cohorts of 3-6 patients receive escalating doses of SAHA until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience DLT. An additional 6-12 patients are treated at the MTD.
After completion of study treatment, patients are followed at 1 month.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
Primary Purpose: Treatment
Unspecified Adult Solid Tumor, Protocol Specific
carboplatin, paclitaxel, vorinostat
Hillman Cancer Center at University of Pittsburgh Cancer Institute
National Cancer Institute (NCI)
Published on BioPortfolio: 2014-07-24T14:25:42-0400
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