Carboplatin and Paclitaxel With or Without Vorinostat in Treating Patients With Advanced 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 is more effective with or without vorinostat in treating non-small cell lung cancer.
Stage IIIA 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:||Phase II Randomized Study of Vorinostat or Placebo in Combination With Carboplatin and Paclitaxel for Patients With Advanced Non-small Cell Lung Cancer|
- Progression-free survival, defined as time from randomization to progression or death due to any cause [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]
- Time to treatment failure [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]
- Percent of patients completing the planned therapy [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]
- Assessment of toxicity [ Time Frame: Up to 1 year ] [ Designated as safety issue: Yes ]
- Response [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]
|Study Start Date:||November 2010|
|Estimated Primary Completion Date:||June 2014 (Final data collection date for primary outcome measure)|
Experimental: Arm I (paclitaxel, carboplatin, vorinostat)
Patients receive paclitaxel IV over 3 hours, and carboplatin IV over 30 minutes on day 0. Patients also receive vorinostat PO once daily on days -2 to 2.
Other Names:Drug: carboplatin
Other Names:Drug: vorinostat
Other Names:Other: laboratory biomarker analysis
Active Comparator: Arm II (paclitaxel, carboplatin, placebo)
Patients receive paclitaxel and carboplatin as in arm I. Patients also receive placebo PO once daily on days -2 to 2.
Other Names:Drug: carboplatin
Other Names:Other: placebo
Other Name: PLCBOther: laboratory biomarker analysis
I. To compare progression-free survival associated with the combination of carboplatin, paclitaxel and vorinostat versus carboplatin, paclitaxel and placebo for patients with previously untreated, advanced NSCLC.
I. To determine the response rate, time to treatment failure, 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 the mechanistic aspects of drug effect by conducting correlative science studies on peripheral blood and archived tumor tissue.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive paclitaxel IV over 3 hours, and carboplatin IV over 30 minutes on day 0. Patients also receive vorinostat orally (PO) once daily on days -2 to 2.
ARM II: Patients receive paclitaxel and carboplatin as in arm I. Patients also receive placebo PO once daily on days -2 to 2.
In both arms, treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 30 days, quarterly for 1 year, and then twice a year thereafter.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01413750
|United States, California|
|City of Hope Medical Center|
|Duarte, California, United States, 91010|
|University of Southern California|
|Los Angeles, California, United States, 90033-0804|
|UC Davis Comprehensive Cancer Center|
|Sacramento, California, United States, 95817|
|United States, Florida|
|H. Lee Moffitt Cancer Center and Research Institute|
|Tampa, Florida, United States, 33612|
|United States, Georgia|
|Atlanta, Georgia, United States, 30322|
|United States, Illinois|
|Peoria, Illinois, United States, 61615|
|Southern Illinois University School of Medicine - Obstetrics and Oncology|
|Springfield, Illinois, United States, 62794|
|United States, Missouri|
|Saint John's Mercy Medical Center|
|Saint Louis, Missouri, United States, 63141|
|United States, North Carolina|
|University of North Carolina|
|Chapel Hill, North Carolina, United States, 27599|
|United States, Pennsylvania|
|Penn State Milton S Hershey Medical Center|
|Hershey, Pennsylvania, United States, 17033-0850|
|University of Pittsburgh Cancer Institute|
|Pittsburgh, Pennsylvania, United States, 15232|
|United States, Tennessee|
|Vanderbilt-Ingram Cancer Center|
|Nashville, Tennessee, United States, 37232|
|United States, Virginia|
|Virginia Commonwealth University|
|Richmond, Virginia, United States, 23298|
|Principal Investigator:||Chandra Belani||Beckman Research Institute|