Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Pleural Effusion

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Antineoplastic Agents

All Drugs and Chemicals

Paclitaxel

Carboplatin

Albumin-Bound Paclitaxel

Vorinostat

Tubulin Modulators

Antimitotic Agents

Histone Deacetylase Inhibitors

Enzyme Inhibitors

vorinostat; IV paclitaxel; IV carboplatin

vorinostat 400 mg capsules once daily. Up to 6 months of treatment

vorinostat

intravenous (IV) paclitaxel 200 mg/m2. Up to 6 months of treatment

Comparator: paclitaxel

intravenous (IV) carboplatin AUC 6mg/min/ml. Up to 6 months of treatment.

Comparator: carboplatin

vorinostat 400 mg placebo capsules once daily. Up to 6 months of treatment

Comparator: placebo

Medical Monitor

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

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)

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.

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.

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).

Merck Sharp & Dohme LLC

The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.

Experimental arm: Vorinostat capsules (400 mg) once daily on Days -4 through 10 of Cycle 1 (25 day treatment cycle) and Days 1 through 14 of each subsequent 21 day treatment cycle; paclitaxel (200 mg/m2) and carboplatin (area under concentration/time curve of 6 mg/min/mL) administered by intravenous (IV) infusion on Day 1 of each treatment cycle.

Vorinostat + Paclitaxel + Carboplatin

Placebo Comparator arm: Placebo capsules once daily on Days -4 through 10 of Cycle 1 (25 day treatment cycle) and Days 1 through 14 of each subsequent 21 day treatment cycle; paclitaxel (200 mg/m2) and carboplatin (area under concentration/time curve of 6 mg/min/mL) administered by intravenous (IV) infusion on Day 1 of each treatment cycle.

Placebo + Paclitaxel + Carboplatin

Total

Less Than 65 years

65 years or Older

Age, Customized

Sex: Female, Male

White

Black

Asian

American Indian or Alaskan Native mix

Race/Ethnicity, Customized

IIIB

Cancer Stage

Eligible

Ineligible

Unknown

Eligibility to receive treatment with Bevacizumab

North America

Europe (United Kingdom, Italy, Germany, and Spain)

Asia

Rest of the World

Geographic region where the participant lived

The study was stopped following a pre-planned interim analysis because the goal for this study to continue was not met, based on 100 events, a reduction in the hazard ratio for progression-free survival by \> 23% with a one-sided p-value \< 0.1

Senior Vice President, Global Clinical Development

Intention-to-treat (ITT) population is defined as all randomized participants. Participants are counted in the group to which they are randomized.

Overall Survival

Full analysis set

(FAS) population defined as all randomized participants who have received at least one dose of study medication. There are 253 participants randomized in the study 5 didn't take any study medication. Therefore, 248 participants are included in this analysis population.

Progression Free Survival

Responder

Non-Responder

Full analysis set

(FAS) population is defined as all randomized participants who have received at least one dose of study medication. There are 253 participants randomized in the study. Five (5) didn't take any study medication. Therefore, 248 participants are included in this analysis population.

Spots Global Cancer Trial Database for 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)

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial