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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)

ClinicalTrials.gov Identifier: NCT00473889 (view full study on clinicaltrials.gov)
Condition:  Stage IIIB or IV Non-Small Cell Lung Cancer
Status:  Terminated


Official Title: 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)

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

Study Type:
Interventional
Study Phase:
Phase 2/Phase 3
Enrollment:
253
Study Start Date:
May 2007
Study Completion Date:
December 2008
Primary Completion Date:
December 2008
Ages Eligible for Study:
18 years and older
Genders Eligible for Study:
Both
Accepts Healthy Volunteers:
No


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

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