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 Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

253 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-31

Study Completion Date

2008-12-31

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

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Detailed Description

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Conditions

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Stage IIIB or IV Non-Small Cell Lung Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

vorinostat; IV paclitaxel; IV carboplatin

Group Type EXPERIMENTAL

vorinostat

Intervention Type DRUG

vorinostat 400 mg capsules once daily. Up to 6 months of treatment

Comparator: paclitaxel

Intervention Type DRUG

intravenous (IV) paclitaxel 200 mg/m2. Up to 6 months of treatment

Comparator: carboplatin

Intervention Type DRUG

intravenous (IV) carboplatin AUC 6mg/min/ml. Up to 6 months of treatment.

2

Placebo; IV paclitaxel; IV carboplatin

Group Type PLACEBO_COMPARATOR

Comparator: paclitaxel

Intervention Type DRUG

intravenous (IV) paclitaxel 200 mg/m2. Up to 6 months of treatment

Comparator: carboplatin

Intervention Type DRUG

intravenous (IV) carboplatin AUC 6mg/min/ml. Up to 6 months of treatment.

Comparator: placebo

Intervention Type DRUG

vorinostat 400 mg placebo capsules once daily. Up to 6 months of treatment

Interventions

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vorinostat

vorinostat 400 mg capsules once daily. Up to 6 months of treatment

Intervention Type DRUG

Comparator: paclitaxel

intravenous (IV) paclitaxel 200 mg/m2. Up to 6 months of treatment

Intervention Type DRUG

Comparator: carboplatin

intravenous (IV) carboplatin AUC 6mg/min/ml. Up to 6 months of treatment.

Intervention Type DRUG

Comparator: placebo

vorinostat 400 mg placebo capsules once daily. Up to 6 months of treatment

Intervention Type DRUG

Other Intervention Names

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Zolinza Taxol Paraplatin

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No