Phase I/II Clinical Trial Evaluating the Use of Vorinostat Combined With Paclitaxel and Radiotherapy in Patients With Inoperable Stage III Non-Small Cell Lung Cancer Unable to Tolerate Cisplatin
PRIMARY OBJECTIVES:
I. To determine the maximum tolerated dose (MTD) of vorinostat when administered in
combination with paclitaxel and thoracic radiation therapy in patients with locally advanced
NSCLC.
SECONDARY OBJECTIVES:
I. To assess the safety and toxicity of vorinostat when administered in combination with
paclitaxel and thoracic radiation therapy in patients with locally advanced NSCLC.
II. To determine the radiological response rate, by computed tomography (CT) scan, of
vorinostat when administered in combination with paclitaxel and thoracic radiation therapy
in patients with locally advanced NSCLC.
III. To describe the progression free survival (PFS) and overall survival (OS) of this
regiment over 3 years of follow up.
OUTLINE: This is a phase I, dose-escalation study of vorinostat followed by a phase II
study.
Patients receive vorinostat orally (PO) once daily (QD), 5 days a week and paclitaxel
intravenously (IV) over 1 hour once a week. Patients also undergo radiation therapy QD, 5
days a week. Treatment repeats every week for 7 courses in the absence of disease
progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 30 days, 12 weeks, every 3
months for 2 years, and then every 6 months for 1 year.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
MTD of vorinostat when administered in combination with paclitaxel and radiotherapy therapy as assessed by NCI Common Toxicity Criteria for Adverse Events (CTCAE) version 3.0 (Phase I)
Defined as the highest dose level at which no more than 1 of 6 patients experiences dose-limiting toxicity.
8 weeks
Yes
Shilpen Patel
Principal Investigator
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
United States: Institutional Review Board
6600
NCT00662311
March 2008
September 2011
Name | Location |
---|---|
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | Seattle, Washington 98109 |