Viewing Study NCT00481078



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Study NCT ID: NCT00481078
Status: COMPLETED
Last Update Posted: 2014-10-30
First Post: 2007-05-31

Brief Title: Vorinostat Carboplatin and Paclitaxel in Treating Patients With Advanced or Metastatic Non-Small Cell Lung Cancer
Sponsor: National Cancer Institute NCI
Organization: National Cancer Institute NCI

Study Overview

Official Title: Randomized Phase II Study of Vorinostat or Placebo in Combination With Carboplatin and Paclitaxel for Patients With Advanced or Metastatic Non-Small Cell Lung Cancer
Status: COMPLETED
Status Verified Date: 2012-12
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: This randomized phase II trial is studying carboplatin paclitaxel and vorinostat to see how well they work compared with carboplatin paclitaxel and a placebo in treating patients with stage III or stage IV non-small cell lung cancer Drugs used in chemotherapy such as carboplatin and paclitaxel work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth It is not yet known whether giving carboplatin and paclitaxel together with vorinostat is more effective than giving carboplatin and paclitaxel together with a placebo in treating non-small cell lung cancer
Detailed Description: PRIMARY OBJECTIVES

I To compare the response rate associated with the combination of vorinostat carboplatin paclitaxel versus carboplatin paclitaxel and placebo for patients with previously untreated advanced NSCLC

SECONDARY OBJECTIVES

I To determine the time to progression and overall survival for the two regimens

II To assess the safety profile of the regimen of vorinostat carboplatin and paclitaxel for patients with advanced NSCLC

III To understand mechanistic aspects of drug effect by conducting correlative science studies on peripheral blood archived tumor tissue and paired biopsies in consenting patients

OUTLINE This is a multicenter randomized study Patients are stratified according to gender and brain metastasis present vs absent Patients are randomized to 1 of 2 treatment arms

Arm I Patients receive oral vorinostat SAHA once daily on days 1-14 and paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 3

Arm II Patients receive an oral placebo once daily on days 1-14 and paclitaxel and carboplatin as in arm l

In both arms treatment repeats every 21 days for 4-6 courses in the absence of disease progression or unacceptable toxicity

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
PHII-82 None None None
N01CM62208 NIH None None
N01CM62209 NIH None None
N01CM62201 NIH None httpsreporternihgovquickSearchN01CM62201