A Phase 1 interventional study of vorinostat and paclitaxel in Unspecified Adult Solid Tumor, Protocol Specific, sponsored by National Cancer Institute (NCI). Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-02-07.
Sponsored by National Cancer Institute (NCI) · Phase 1, Interventional, and Treatment
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. 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
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.
National Cancer Institute (NCI) is the lead sponsor of 3,506 studies on the registry; 334 are open to participants now.
Of its 402 completed or terminated interventional studies of FDA-regulated products, 365 (91%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
No untreated brain metastases
No more than 2 prior chemotherapy regimens for advanced/metastatic disease
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.
Drug: vorinostat · Drug: paclitaxel · Drug: carboplatin · Other: laboratory biomarker analysis · Other: pharmacological study
Given orally
Also known as: L-001079038, SAHA, suberoylanilide hydroxamic acid, Zolinza
Given IV
Also known as: Anzatax, Asotax, TAX, Taxol
Given IV
Also known as: Carboplat, CBDCA, JM-8, Paraplat, Paraplatin
Correlative studies
Correlative studies
Also known as: pharmacological studies
MTD of vorinostat defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience DLT
Time frame: 21 days
Toxicity graded using the CTC version 2.0
Tables will be created to summarize these toxicities by dose and by course.
Time frame: Up to 1 month after completion of study treatment
Overall survival
Summarized with Kaplan-Meier plots.
Time frame: Up to 1 month after completion of study treatment
Time to failure
Summarized with Kaplan-Meier plots.
Time frame: Up to 1 month after completion of study treatment
Response defined using the RECIST criteria
Time frame: Up to 1 month after completion of study treatment
This study is completed, as verified in Feb 2013. You cannot join it, but the record below documents what was studied.
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National Cancer Institute (NCI)