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)

This study has been terminated.
(The study was terminated based on the recommendation by the DSMB following a pre-planned protocol interim analysis because the endpoint was not achieved.)
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00473889
First received: May 14, 2007
Last updated: November 14, 2013
Last verified: November 2013
  Purpose

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


Condition Intervention Phase
Stage IIIB or IV Non-Small Cell Lung Cancer
Drug: vorinostat
Drug: Comparator: paclitaxel
Drug: Comparator: carboplatin
Drug: Comparator: placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Overall Survival [ Time Frame: Start of treatment to death ] [ Designated as safety issue: No ]
    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 [ Time Frame: Start of treatment to disease progression or death ] [ Designated as safety issue: No ]
    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 [ Time Frame: Every 42 days from start of treatment until disease response ] [ Designated as safety issue: No ]
    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).


Enrollment: 253
Study Start Date: May 2007
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
vorinostat; IV paclitaxel; IV carboplatin
Drug: vorinostat
vorinostat 400 mg capsules once daily. Up to 6 months of treatment
Other Name: Zolinza
Drug: Comparator: paclitaxel
intravenous (IV) paclitaxel 200 mg/m2. Up to 6 months of treatment
Other Name: Taxol
Drug: Comparator: carboplatin
intravenous (IV) carboplatin AUC 6mg/min/ml. Up to 6 months of treatment.
Other Name: Paraplatin
Placebo Comparator: 2
Placebo; IV paclitaxel; IV carboplatin
Drug: Comparator: paclitaxel
intravenous (IV) paclitaxel 200 mg/m2. Up to 6 months of treatment
Other Name: Taxol
Drug: Comparator: carboplatin
intravenous (IV) carboplatin AUC 6mg/min/ml. Up to 6 months of treatment.
Other Name: Paraplatin
Drug: Comparator: placebo
vorinostat 400 mg placebo capsules once daily. Up to 6 months of treatment

  Eligibility

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00473889

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00473889     History of Changes
Other Study ID Numbers: 0683-056, MK0683-056, 2006_539
Study First Received: May 14, 2007
Results First Received: September 3, 2009
Last Updated: November 14, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Vorinostat
Carboplatin
Paclitaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Histone Deacetylase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on September 18, 2014