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)

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 Overview

• Status: Terminated
• Conditions: Stage IIIB or IV Non-Small Cell Lung Cancer
• Intervention / Treatment: Drug: vorinostat; Drug: Comparator: paclitaxel; Drug: Comparator: carboplatin; Drug: Comparator: placebo

• Study Type: Interventional
• Enrollment (Actual): 253
• Phase: Phase 2; Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; vorinostat; IV paclitaxel; IV carboplatin	Drug: vorinostat; vorinostat 400 mg capsules once daily. Up to 6 months of treatment; Other Names: Zolinza; Drug: Comparator: paclitaxel; intravenous (IV) paclitaxel 200 mg/m2. Up to 6 months of treatment; Other Names: Taxol; Drug: Comparator: carboplatin; intravenous (IV) carboplatin AUC 6mg/min/ml. Up to 6 months of treatment.; Other Names: 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 Names: Taxol; Drug: Comparator: carboplatin; intravenous (IV) carboplatin AUC 6mg/min/ml. Up to 6 months of treatment.; Other Names: Paraplatin; Drug: Comparator: placebo; vorinostat 400 mg placebo capsules once daily. Up to 6 months of treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Start of treatment to death

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Start of treatment to disease progression or death
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).	Every 42 days from start of treatment until disease response

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: May 1, 2007
• Primary Completion (Actual): December 1, 2008
• Study Completion (Actual): December 1, 2008

Study Registration Dates

• First Submitted: May 14, 2007
• First Submitted That Met QC Criteria: May 14, 2007
• First Posted (Estimate): May 16, 2007

Study Record Updates

• Last Update Posted (Estimate): July 3, 2015
• Last Update Submitted That Met QC Criteria: June 8, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Histone Deacetylase Inhibitors; Carboplatin; Paclitaxel; Vorinostat
• Other Study ID Numbers: 0683-056; MK0683-056; 2006_539