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)

Study Overview
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Brief Summary
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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

Official Title
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A Phase II/III Randomized, Double-Blind Study of Paclitaxel Plus Carboplatin in Combination With Vorinostat or Placebo in Patients With Stage IIIB (With Pleural Effusion) or Stage IV Non-Small-Cell Lung Cancer (NSCLC)

Conditions
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Stage IIIB or IV Non-Small Cell Lung Cancer

Intervention / Treatment
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* Drug: vorinostat
* Drug: Comparator: paclitaxel
* Drug: Comparator: carboplatin
* Drug: Comparator: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males and females at least 18 years of age who have confirmed diagnosis of Non-small Cell Lung Cancer Patients with no systemic prior systemic treatment for lung cancer except patients at least 12 months from prior adjuvant therapy Adequate bone marrow,kidney and liver function Must be recovered and at least 4 weeks from major surgery or radiation ECOG (Eastern Cooperative Oncology Group) performance status of 0 or 1 Men and women must agree to use birth control during the study Women able to have children must have a negative pregnancy test 14 days before study enrollment Exclusion Criteria: Patients with prior treatment with other investigational agents less than 4 weeks before study enrollment Pregnant or nursing female patients Patients who are HIV positive Patients who have Hepatitis A, B, or C Patients unable to take study medication by mouth Patients with untreated brain cancer Patient eligible for treatment with bevacizumab and for whom bevacizumab is available

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>vorinostat; IV paclitaxel; IV carboplatin | Drug: vorinostat<br>* vorinostat 400 mg capsules once daily. Up to 6 months of treatment<br>* Other names: Zolinza;Drug: Comparator: paclitaxel<br>* intravenous (IV) paclitaxel 200 mg/m2. Up to 6 months of treatment<br>* Other names: Taxol;Drug: Comparator: carboplatin<br>* intravenous (IV) carboplatin AUC 6mg/min/ml. Up to 6 months of treatment.<br>* Other names: Paraplatin;|
| Placebo Comparator: 2<br>Placebo; IV paclitaxel; IV carboplatin | Drug: Comparator: paclitaxel<br>* intravenous (IV) paclitaxel 200 mg/m2. Up to 6 months of treatment<br>* Other names: Taxol;Drug: Comparator: carboplatin<br>* intravenous (IV) carboplatin AUC 6mg/min/ml. Up to 6 months of treatment.<br>* Other names: Paraplatin;Drug: Comparator: placebo<br>* vorinostat 400 mg placebo capsules once daily. Up to 6 months of treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival | Defined as the time from date of randomization to death due to any cause. Patients without documented death at the time of the final analysis will be censored at the date of the last follow-up. | Start of treatment to death | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression Free Survival | Defined as the time from randomization to the first documented disease progression or death due to any cause, whichever occurs first. Disease progression is defined as at least a 20% increase in sum of the longest diameter of all target lesions, the appearance of a new lesion, or an increase in non-target lesions. | Start of treatment to disease progression or death | 
| Number of Participants Who Had a Disease Response to Treatment | Response to treatment is defined as a complete response (CR) or partial response (PR) to treatment. Confirmation of response required a second assessment performed at least 4 weeks after the initial assessment. (PR is defined as at least a 30% reduction in sum of the longest diameter of all target lesions and no increase in non-target lesions). | Every 42 days from start of treatment until disease response |