A Clinical Trial of Vorinostat (MK0683, SAHA) in Combination With FDA Approved Cancer Drugs in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)(0683-056)

Sponsor: Merck Sharp & Dohme LLC
Study ID: NCT00473889
Phase: PHASE2/PHASE3
Status: Terminated

Conditions

Stage IIIB or IV Non-Small Cell Lung Cancer

Eligibility Criteria

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

Interventions

vorinostat — DRUG
vorinostat 400 mg capsules once daily. Up to 6 months of treatment
Comparator: paclitaxel — DRUG
intravenous (IV) paclitaxel 200 mg/m2. Up to 6 months of treatment
Comparator: carboplatin — DRUG
intravenous (IV) carboplatin AUC 6mg/min/ml. Up to 6 months of treatment.
Comparator: placebo — DRUG
vorinostat 400 mg placebo capsules once daily. Up to 6 months of treatment

Study Details

This Phase III clinical trial which incorporates an initial Phase II component will determine the survival of advanced Non-small cell lung cancer patients when treated with MK0683 and paclitaxel plus carboplatin

Key Dates

Start date: May 31, 2007
Status verified: Jun 2015
Primary completion: Dec 31, 2008
Completion: Dec 31, 2008

Study Design

Enrollment: 253 participants (actual)
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Arms

Experimental: 1
vorinostat; IV paclitaxel; IV carboplatin
Placebo Comparator: 2
Placebo; IV paclitaxel; IV carboplatin

Primary Outcome Measure

Overall Survival [ Time Frame: Start of treatment to death ]