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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)

Primary Purpose

Stage IIIB or IV Non-Small Cell Lung Cancer

Status
Terminated
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
vorinostat
Comparator: paclitaxel
Comparator: carboplatin
Comparator: placebo
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stage IIIB or IV Non-Small Cell Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    1

    2

    Arm Description

    vorinostat; IV paclitaxel; IV carboplatin

    Placebo; IV paclitaxel; IV carboplatin

    Outcomes

    Primary Outcome Measures

    Overall Survival
    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

    Progression Free Survival
    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
    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).

    Full Information

    First Posted
    May 14, 2007
    Last Updated
    June 8, 2015
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00473889
    Brief Title
    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)
    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)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2015
    Overall Recruitment Status
    Terminated
    Why Stopped
    The study was terminated based on the recommendation by the DSMB following a pre-planned protocol interim analysis because the endpoint was not achieved.
    Study Start Date
    May 2007 (undefined)
    Primary Completion Date
    December 2008 (Actual)
    Study Completion Date
    December 2008 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Merck Sharp & Dohme LLC

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Stage IIIB or IV Non-Small Cell Lung Cancer

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    253 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Experimental
    Arm Description
    vorinostat; IV paclitaxel; IV carboplatin
    Arm Title
    2
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo; IV paclitaxel; IV carboplatin
    Intervention Type
    Drug
    Intervention Name(s)
    vorinostat
    Other Intervention Name(s)
    Zolinza
    Intervention Description
    vorinostat 400 mg capsules once daily. Up to 6 months of treatment
    Intervention Type
    Drug
    Intervention Name(s)
    Comparator: paclitaxel
    Other Intervention Name(s)
    Taxol
    Intervention Description
    intravenous (IV) paclitaxel 200 mg/m2. Up to 6 months of treatment
    Intervention Type
    Drug
    Intervention Name(s)
    Comparator: carboplatin
    Other Intervention Name(s)
    Paraplatin
    Intervention Description
    intravenous (IV) carboplatin AUC 6mg/min/ml. Up to 6 months of treatment.
    Intervention Type
    Drug
    Intervention Name(s)
    Comparator: placebo
    Intervention Description
    vorinostat 400 mg placebo capsules once daily. Up to 6 months of treatment
    Primary Outcome Measure Information:
    Title
    Overall Survival
    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.
    Time Frame
    Start of treatment to death
    Secondary Outcome Measure Information:
    Title
    Progression Free Survival
    Description
    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.
    Time Frame
    Start of treatment to disease progression or death
    Title
    Number of Participants Who Had a Disease Response to Treatment
    Description
    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).
    Time Frame
    Every 42 days from start of treatment until disease response

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Medical Monitor
    Organizational Affiliation
    Merck Sharp & Dohme LLC
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    26521238
    Citation
    Beaumont H, Souchet S, Labatte JM, Iannessi A, Tolcher AW. Changes of lung tumour volume on CT - prediction of the reliability of assessments. Cancer Imaging. 2015 Oct 31;15:17. doi: 10.1186/s40644-015-0052-2.
    Results Reference
    derived

    Learn more about this trial

    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)

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