Finding studies
Finding studies
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Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
National Cancer Institute (NCI)
PRIMARY OBJECTIVES: I. Determine the recommended phase II dose of vorinostat (SAHA) when administered with paclitaxel and carboplatin in patients with advanced or refractory solid tumors. SECONDARY OBJECTIVES: I. Determine the dose-limiting toxicity (DLT) and other toxic effects of this regimen in these patients. II. Assess, preliminarily, evidence of antitumor activity of this regimen in these patients. III. Determine the pharmacokinetic parameters of this regimen in these patients. IV. 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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
