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)

• Status: Terminated
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Albumin-Bound Paclitaxel; Carboplatin; Paclitaxel; Vorinostat

Criteria

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