A Clinical Trial of Vorinostat (MK0683, SAHA) in Combination With FDA Approved Cancer Drugs in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) - Full Text View

Sponsor:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00473889

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 II Phase III

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:

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Paclitaxel Carboplatin Suberoylanilide hydroxamic acid

U.S. FDA Resources

Further study details as provided by Merck:

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

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

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

No publications provided

Responsible Party:	Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier:	NCT00473889 History of Changes
Other Study ID Numbers:	2006_539, MK0683-056
Study First Received:	May 14, 2007
Results First Received:	September 3, 2009
Last Updated:	April 20, 2010
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Vorinostat
Carboplatin

Paclitaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic
Histone Deacetylase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on February 09, 2012