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)

Stage IIIB or IV Non-Small Cell Lung Cancer Clinical Trial

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00473889
• Other study ID #: 0683-056
• Secondary ID: MK0683-0562006_5
• Status: Terminated
• Phase: Phase 2/Phase 3
• First received: May 14, 2007
• Last updated: June 8, 2015
• Start date: May 2007
• Est. completion date: December 2008

Study information

• Verified date: June 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 253
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Stage IIIB or IV Non-Small Cell Lung Cancer

Intervention

Drug:
• vorinostat
vorinostat 400 mg capsules once daily. Up to 6 months of treatment
• Comparator: paclitaxel
intravenous (IV) paclitaxel 200 mg/m2. Up to 6 months of treatment
• Comparator: carboplatin
intravenous (IV) carboplatin AUC 6mg/min/ml. Up to 6 months of treatment.
• Comparator: placebo
vorinostat 400 mg placebo capsules once daily. Up to 6 months of treatment

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No