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)

Phase 2

Terminated

• Conditions: Stage IIIB or IV Non-Small Cell Lung Cancer
• Interventions: Drug: vorinostat

• Registration Number: NCT00473889
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2007-05
• Study First Submitted: 2007-05-14
• Study First Submitted QC: 2007-05-14
• Study First Posted: 2007-05-16
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Results First Submitted: 2009-09-03
• Results First Submitted QC: 2009-09-03
• Results First Posted: 2009-10-12
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-08
• Last Update Posted: 2015-07-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 253

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	vorinostat	vorinostat; IV paclitaxel; IV carboplatin

Primary Outcome Measures

Name	Time	Method
Overall Survival	Start of treatment to death	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.

Secondary Outcome Measures

Name	Time	Method
Progression Free Survival	Start of treatment to disease progression or death	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.
Number of Participants Who Had a Disease Response to Treatment	Every 42 days from start of treatment until disease response	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).