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)

Merck Sharp & Dohme (MSD)

Status and phase: Terminated; Phase 3; Phase 2

Conditions: Stage IIIB or IV Non-Small Cell Lung Cancer

Treatments: Drug: Comparator: placebo; Drug: Comparator: carboplatin; Drug: vorinostat; Drug: Comparator: paclitaxel

Study type: Interventional

Funder types: Industry

Identifiers

NCT00473889

2006_539

0683-056

MK0683-056

Details and patient eligibility

About

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

Enrollment: 253 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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253 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

vorinostat; IV paclitaxel; IV carboplatin

Treatment:

Drug: Comparator: paclitaxel

Drug: vorinostat

Drug: Comparator: carboplatin

2

Placebo Comparator group

Description:

Placebo; IV paclitaxel; IV carboplatin

Treatment:

Drug: Comparator: paclitaxel

Drug: Comparator: carboplatin

Drug: Comparator: placebo