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

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. )

First Received: May 14, 2007 Last Updated: September 3, 2009 History of Changes

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

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
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: Defined as the time from date of randomization to death due to any cause ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Progression Free Survival [ Time Frame: Time from randomization to the first documented disease progression or death due to any cause, whichever occurs first ] [ Designated as safety issue: No ]
Response Rate [ Time Frame: Every 42 days until documented response ] [ Designated as safety issue: No ]

Enrollment:	1000
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
1: Experimental vorinostat; IV paclitaxel; IV carboplatin	Drug: vorinostat vorinostat 400 mg capsules once daily. Up to 6 months of treatment Drug: Comparator: paclitaxel intravenous (IV) paclitaxel 200 mg/m2. Up to 6 months of treatment Drug: Comparator: carboplatin intravenous (IV) carboplatin AUC 6mg/min/ml. Up to 6 months of treatment.
2: Placebo Comparator Placebo; IV paclitaxel; IV carboplatin	Drug: Comparator: paclitaxel intravenous (IV) paclitaxel 200 mg/m2. Up to 6 months of treatment Drug: Comparator: carboplatin intravenous (IV) carboplatin AUC 6mg/min/ml. Up to 6 months of treatment. 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:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2006_539, MK0683-056
Study First Received:	May 14, 2007
Results First Received:	September 3, 2009
Last Updated:	September 3, 2009
ClinicalTrials.gov Identifier:	NCT00473889 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Anticarcinogenic Agents
Anti-Inflammatory Agents
Thoracic Neoplasms
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Neoplasms by Site
Respiratory Tract Diseases
Sensory System Agents
Lung Neoplasms
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Respiratory Tract Neoplasms
Neoplasms by Histologic Type

Vorinostat
Mitosis Modulators
Enzyme Inhibitors
Carboplatin
Antimitotic Agents
Protective Agents
Pharmacologic Actions
Carcinoma
Neoplasms
Paclitaxel
Analgesics, Non-Narcotic
Lung Diseases
Tubulin Modulators
Peripheral Nervous System Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on February 08, 2010