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)

Merck Sharp & Dohme LLC0 sites253 target enrollmentMay 2007

ConditionsStage IIIB or IV Non-Small Cell Lung Cancer

Interventionsvorinostat

Drugsvorinostat Comparator: paclitaxel Comparator: carboplatin Comparator: placebo

Overview

Phase: Phase 2
Intervention: vorinostat
Conditions: Stage IIIB or IV Non-Small Cell Lung Cancer
Sponsor: Merck Sharp & Dohme LLC
Enrollment: 253
Primary Endpoint: Overall Survival
Status: Terminated
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

May 2007

End Date

December 2008

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Merck Sharp & Dohme LLC

Responsible Party

Sponsor

Eligibility 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

Arms & Interventions

1

vorinostat; IV paclitaxel; IV carboplatin

Intervention: vorinostat

Outcomes

Primary Outcomes

Overall Survival

Time Frame: 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 Outcomes

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