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)
18 Years
N/A
Both
Stage IIIB or IV Non-Small Cell Lung Cancer
Trial Information
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)
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Outcome Measure:
Overall Survival
Outcome Description:
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.
Outcome Time Frame:
Start of treatment to death
Safety Issue:
No
Principal Investigator
Medical Monitor
Investigator Role:
Study Director
Investigator Affiliation:
Merck
Authority:
United States: Food and Drug Administration
Study ID:
2006_539
NCT ID:
NCT00473889
Start Date:
May 2007
Completion Date:
December 2008
Related Keywords:
- Stage IIIB or IV Non-Small Cell Lung Cancer
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
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