Carboplatin and Paclitaxel With or Without Vorinostat in Treating Patients With Advanced Non-Small Cell Lung Cancer

Part of paid clinical trials in Duarte, California.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT01413750
Phase
PHASE2
Status
Terminated

Conditions

  • Stage IIIA Lung Non-Small Cell Cancer AJCC v7
  • Stage IIIB Lung Non-Small Cell Cancer AJCC v7
  • Stage IV Lung Non-Small Cell Cancer AJCC v7

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Carboplatin — DRUG
    Given IV
  • Laboratory Biomarker Analysis — OTHER
    Correlative studies
  • Paclitaxel — DRUG
    Given IV
  • Placebo Administration — OTHER
    Given PO
  • Vorinostat — DRUG
    Given PO

Study Details

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.

Key Dates

Start date
Nov 8, 2010
Status verified
Oct 2024
Primary completion
Apr 14, 2013
Completion
Apr 14, 2013

Study Design

Enrollment
23 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • 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.

Primary Outcome Measure

Progression-free Survival (PFS) [ Time Frame: From first day of treatment to the first observation of disease progression or death due to any cause, assessed up to 1 year ]

Locations (13)

FacilityCityStateZIPSite coordinators
City of Hope Comprehensive Cancer CenterDuarteCalifornia91010-
USC / Norris Comprehensive Cancer CenterLos AngelesCalifornia90033-
University of California Davis Comprehensive Cancer CenterSacramentoCalifornia95817-
Moffitt Cancer CenterTampaFlorida33612-
Emory University Hospital/Winship Cancer InstituteAtlantaGeorgia30322-
Illinois CancerCare-PeoriaPeoriaIllinois61615-
Southern Illinois University School of MedicineSpringfieldIllinois62702-
Mercy Hospital Saint LouisSt LouisMissouri63141-
UNC Lineberger Comprehensive Cancer CenterChapel HillNorth Carolina27599-
Penn State Milton S Hershey Medical CenterHersheyPennsylvania17033-0850-
University of Pittsburgh Cancer Institute (UPCI)PittsburghPennsylvania15232-
Vanderbilt University/Ingram Cancer CenterNashvilleTennessee37232-
Virginia Commonwealth University/Massey Cancer CenterRichmondVirginia23298-

Find similar trials in Duarte, CA

By research site
City of Hope Comprehensive Cancer Center· Duarte, CAUSC / Norris Comprehensive Cancer Center· Los Angeles, CAUniversity of California Davis Comprehensive Cancer Center· Sacramento, CAMoffitt Cancer Center· Tampa, FLEmory University Hospital/Winship Cancer Institute· Atlanta, GAIllinois CancerCare-Peoria· Peoria, IL

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