Stage IIIB or IV Non-Small Cell Lung CancerPhase 2/3NCT00473889

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 2/3 study testing vorinostat, Comparator: paclitaxel and Comparator: carboplatin in people with Stage IIIB or IV Non-Small Cell Lung Cancer, run by Merck Sharp & Dohme LLC.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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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 Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Stage IIIB or IV Non-Small Cell Lung Cancer
What is being tested?: vorinostat, Comparator: paclitaxel and Comparator: carboplatin
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 253 participants
Where: No sites listed yet
Study dates: May 2007to Dec 2008
Phase: Phase 2/3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

About this 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)

Conditions: Stage IIIB or IV Non-Small Cell Lung Cancer
Being tested: vorinostat, Comparator: paclitaxel, Comparator: carboplatin, Comparator: placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

vorinostatDrug
Also called Zolinza
vorinostat 400 mg capsules once daily. Up to 6 months of treatment
Comparator: paclitaxelDrug
Also called Taxol
intravenous (IV) paclitaxel 200 mg/m2. Up to 6 months of treatment
Comparator: carboplatinDrug
Also called Paraplatin
intravenous (IV) carboplatin AUC 6mg/min/ml. Up to 6 months of treatment.
Comparator: placeboDrug
vorinostat 400 mg placebo capsules once daily. Up to 6 months of treatment

Study groups in NCT00473889
Study group	Role	What they receive
1	Experimental	vorinostat; IV paclitaxel; IV carboplatin Receives: Drug: vorinostat; Drug: Comparator: paclitaxel; Drug: Comparator: carboplatin
2	Placebo comparator	Placebo; IV paclitaxel; IV carboplatin Receives: Drug: Comparator: paclitaxel; Drug: Comparator: carboplatin; Drug: Comparator: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Start of treatment to death

Secondary outcomes (2)

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.
Measured: 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).
Measured: Every 42 days from start of treatment until disease response

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2007Dec 2008

First posted16 May 2007 (estimated)
Study startMay 2007
Primary completionDec 2008
Study completionDec 2008

Why it stopped: The study was terminated based on the recommendation by the DSMB following a pre-planned protocol interim analysis because the endpoint was not achieved.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Stage IIIB or IV Non-Small Cell Lung CancerStudies of the same condition, open and under way.
More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2/3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 253 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00473889
Sponsor's protocol ID: 0683-056
Other IDs: MK0683-056, 2006_539
Status last verified: Jun 2015
First submitted: 14 May 2007
Last updated: 3 Jul 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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.
PubMed 26521238

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Stage IIIB or IV Non-Small Cell Lung Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

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)
ClinicalTrials.gov ID: NCT00473889
Acronym / sponsor ID: 0683-056
Conditions: Stage IIIB or IV Non-Small Cell Lung Cancer
Phase: Phase 2/3
Study type: Interventional
Recruitment status: TerminatedReason stopped: The study was terminated based on the recommendation by the DSMB following a pre-planned protocol interim analysis because the endpoint was not achieved.
Enrolment: 253 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: May 2007
Primary completion: Dec 2008 (actual)
Study completion: Dec 2008 (actual)
First posted: 16 May 2007 (estimated)
Results: Posted 12 Oct 2009

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
1	Experimental	Drug: vorinostat, Drug: Comparator: paclitaxel, Drug: Comparator: carboplatinvorinostat; IV paclitaxel; IV carboplatin
2	Placebo comparator	Drug: Comparator: paclitaxel, Drug: Comparator: carboplatin, Drug: Comparator: placeboPlacebo; IV paclitaxel; IV carboplatin

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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

Key exclusion criteria (7 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
vorinostatAlso: Zolinzavorinostat 400 mg capsules once daily. Up to 6 months of treatment	Drug	1
Comparator: paclitaxelAlso: Taxolintravenous (IV) paclitaxel 200 mg/m2. Up to 6 months of treatment	Drug	1, 2
Comparator: carboplatinAlso: Paraplatinintravenous (IV) carboplatin AUC 6mg/min/ml. Up to 6 months of treatment.	Drug	1, 2
Comparator: placebovorinostat 400 mg placebo capsules once daily. Up to 6 months of treatment	Drug	2

Primary outcome

Overall Survival
Time frame: Start of treatment to death
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.

2 secondary outcomes

Progression Free Survival
Time frame: Start of treatment to disease progression or death
Number of Participants Who Had a Disease Response to Treatment
Time frame: Every 42 days from start of treatment until disease response

Results and safety

Results posted to the registry on 12 Oct 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Vorinostat + Paclitaxel + Carboplatin	126	43
Placebo + Paclitaxel + Carboplatin	127	63

Primary outcome: Overall Survival

Time frame: Start of treatment to death. Median (Full Range). Unit: Months

Measure	Vorinostat + Paclitaxel + Carboplatin n = 126	Placebo + Paclitaxel + Carboplatin n = 127
Value	11.0 (0.2 to 17.3)	14.0 (0.03 to 18.7)

Placebo + Paclitaxel + Carboplatin: p = 0.992, Stratified Log Rank

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

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution.. Other adverse events reported at 3% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Vorinostat + Paclitaxel + Carboplatin	63 of 124 (50.8%)	114 of 124 (91.9%)	Not reported
Placebo + Paclitaxel + Carboplatin	45 of 124 (36.3%)	117 of 124 (94.4%)	Not reported

Limitations and caveats (from the sponsor): 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

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 26521238Beaumont 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Monitor study director

Merck Sharp & Dohme LLC

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing vorinostat, Comparator: paclitaxel and Comparator: carboplatin in people with Stage IIIB or IV Non-Small Cell Lung Cancer, run by Merck Sharp & Dohme LLC.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 3 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Oct 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (time frame: Start of treatment to death). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00473889, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2015.