Vorinostat, Carboplatin, and Paclitaxel in Treating Patients With Advanced or Metastatic Non-Small Cell Lung Cancer

Part of paid clinical trials in Duarte, California.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT00481078
Phase
PHASE2
Status
Completed

Conditions

  • Recurrent Non-small Cell Lung Cancer
  • Stage IIIB Non-small Cell Lung Cancer
  • Stage IV Non-small Cell Lung Cancer

Eligibility Criteria

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

Interventions

  • vorinostat — DRUG
    Given PO
  • paclitaxel — DRUG
    Given IV
  • carboplatin — DRUG
    Given IV
  • placebo — OTHER
    Given PO
  • laboratory biomarker analysis — OTHER
    Correlative studies

Study Details

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

Key Dates

Start date
May 31, 2007
Status verified
Dec 2012
Primary completion
Jul 31, 2009
Completion
Jul 31, 2009

Study Design

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

Arms

  • 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.
  • 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.

Primary Outcome Measure

Response Rate [ Time Frame: Assessed every two cycles ]

Locations (1)

FacilityCityStateZIPSite coordinators
City of HopeDuarteCalifornia91010-

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By research site
City of Hope· Duarte, CA

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