Vorinostat, Carboplatin, and Paclitaxel in Treating Patients With Advanced or Metastatic Non-Small Cell Lung Cancer
Recurrent Non-small Cell Lung Cancer
Stage IIIB Non-small Cell Lung Cancer
Stage IV Non-small Cell Lung Cancer
Other: laboratory biomarker analysis
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|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|
- Response Rate [ Time Frame: Assessed every two cycles ] [ Designated as safety issue: No ]
Each patient will be assigned one of the following categories: 1) complete response, 2) partial response, 3) stable disease, 4) progressive disease, 5) early death from malignant disease, 6) early death from toxicity, 7) early death because of other cause, or 9) unknown (not assessable, insufficient data).
Patients with confirmed CR or PR according to the RECIST criteria were considered to have responded to treatment.
- Progression-free Survival [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]Evaluated using the Kaplan-Meier method. Compared between arms using the log-rank test.
- Overall Survival [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]Evaluated using the Kaplan-Meier method. Compared between arms using the log-rank test.
|Study Start Date:||May 2007|
|Study Completion Date:||July 2009|
|Primary Completion Date:||July 2009 (Final data collection date for primary outcome measure)|
Experimental: Arm I (vorinostat, paclitaxel, carboplatin)
Patients receive oral vorinostat (SAHA) at 400 mg once daily on days 1-14 and paclitaxel IV 200 mg/m2 over 3 hours and carboplatin IV dosed to achieve an area under the concentration versus time curve of 6 mg/mLXmin over 30 minutes on day 3.
Other Names:Drug: paclitaxel
Other Names:Drug: carboplatin
Other Names:Other: laboratory biomarker analysis
Active Comparator: Arm II (placebo, paclitaxel, carboplatin)
Patients receive an oral placebo once daily on days 1-14 and paclitaxel and carboplatin as in arm l.
Other Names:Drug: carboplatin
Other Names:Other: placebo
Other Name: PLCBOther: laboratory biomarker analysis
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00481078
|United States, California|
|City of Hope|
|Duarte, California, United States, 91010|
|Principal Investigator:||Chandra Belani||Penn State Hershey Cancer Institute|