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

This clinical trial will determine the survival of advanced Non-small cell lung cancer patients when treated with MK0683 and paclitaxel plus carboplatin

Official Title

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

Stage IIIB Non-Small Cell Lung Cancer, Stage IV Non-Small Cell Lung Cancer

Study Type

Interventional

Study Design

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Further Details

• Primary Outcome Measures: Overall survival
• Secondary Outcome Measures: Progression Free Survival and Response Rate

Study Start

May 2007

Eligibility & Criteria

• Ages Eligible for Study: 18 Years and above
• Genders Eligible for Study: Both

Inclusion Criteria:

• Males and females at least 18 years of age who have confirmed diagnosis of Non-small Cell Lung Cancer
• Patients with no prior 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 treatment
• 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 bevacizamab

Total Enrolment

1000

Contact Details

• Merck Sharp & Dohme (Australia) Inc., South Granville, NSW 2142, Australia; Recruiting

David Woolner: 61-2-9795-9500