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Carcinoma, Non-Small-Cell LungPhase 1/2NCT00251589

A Phase I/II Clinical Trial of Vorinostat in Combination With Erlotinib for Patients With Relapsed/Refractory Non-Small-Cell Lung Cancer (0683-025)

A Phase 1/2 study testing Vorinostat and erlotinib in people with Carcinoma, Non-Small-Cell Lung, 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

The reason for this study will be to find the safest maximum tolerated dose of oral vorinostat in combination with erlotinib [Tarceva (TM)] that can be given to patients with lung cancer who have relapsed or failed other therapy for the disease. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Carcinoma, Non-Small-Cell Lung
What is being tested?
Vorinostat and erlotinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
23 participants
Where
No sites listed yet
Study dates
Jan 2006to Oct 2007
Phase
Phase 1/2
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 18 years of age and older with a confirmed diagnosis of non-small-cell lung cancer (NSCLC) who have failed at least one prior treatment for NSCLC.
  • Patients must have proven disease by CT scan or MRI.
  • Patients must be at least 4 weeks from any chemotherapy for cancer or from any surgeries or from any treatment using an investigational drug.
  • Patients must be 2 weeks out from radiation therapy.
  • At screening the patient must have normal lab results and can not be pregnant.
  • Women and men must agree to practice adequate birth control during the study.
  • Patient has the ability to understand and sign the consent form.

Who cannot join

  • Patient had prior treatment with vorinostat or erlotinib.
  • Patient has any of the following conditions: active infections including hepatitis B or C, unstable brain metastases, swallowing difficulties, heart problems, significant eye abnormalities, drug or alcohol abuse, mental illness or pregnancy.

About this study

Official title: A Phase I/II Clinical Trial of Oral Vorinostat (MK0683) in Combination With Erlotinib in Patients With Relapsed/Refractory Non-Small-Cell Lung Cancer

The reason for this study will be to find the safest maximum tolerated dose of oral vorinostat in combination with erlotinib [Tarceva (TM)] that can be given to patients with lung cancer who have relapsed or failed other therapy for the disease. Once the safest maximum tolerated dose of vorinostat is determined, patients enrolled in the clinical trial will continue vorinostat and erlotinib for up to 8 months. Safety and effectiveness will also be evaluated.

Being tested
Vorinostat, erlotinib
Keywords
Relapsed Non-Small-Cell Lung Cancer, Refractory Non-Small-Cell Lung Cancer
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

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

  • VorinostatDrug

    Also called MK0683, Zolinza®

    Vorinostat 200 mg twice a day for 3 days a week.

  • VorinostatDrug

    Also called MK0683, Zolinza®

    Vorinostat 300 mg once a day for 3 days a week.

  • VorinostatDrug

    Also called MK0683, Zolinza®

    Vorinostat 300 mg twice a day for 3 days a week.

  • VorinostatDrug

    Also called MK0683, Zolinza®

    Vorinostat 400 mg once a day for 21 out of 28 days.

  • erlotinibDrug

    Also called Tarceva ®

    erlotinib 150 mg once a day.

Study groups in NCT00251589
Study groupRoleWhat they receive
Vorinostat 200 mg b.i.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wkExperimentalVorinostat 200 mg twice a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the study and determined to be the MTD and therefore the recommended Phase II dose. Of the 16 patients treated at this dose level, 4 were assigned to the Phase I portion of the study and 12 were assigned to the Phase II portion
Receives: Drug: Vorinostat; Drug: erlotinib
Vorinostat 300 mg q.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wkExperimentalVorinostat 300 mg once a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the amended study and exceeded the MTD. All patients treated at this dose level were assigned to the Phase I portion of the study.
Receives: Drug: Vorinostat; Drug: erlotinib
Vorinostat 300 mg b.i.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wkExperimentalVorinostat 300 mg twice a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the study and exceeded the MTD. All patients treated at this dose level were assigned to the Phase I portion of the study.
Receives: Drug: Vorinostat; Drug: erlotinib
Vorinostat 400 mg q.d. 21d/4wk + Erlotinib 150 mg q.d. 7d/wkExperimentalVorinostat 400 mg once a day for 21 out of 28 days + erlotinib 150 mg once a day was evaluated in the Phase I portion of the original study and exceeded MTD. This cohort was then amended (Amendment 1) to identify a more tolerable once daily vorinostat dosing regimen. All patients treated at this dose level were assigned to the Phase I portion of the study.
Receives: Drug: Vorinostat; Drug: erlotinib

What is being measured

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

  1. Dose Limiting Toxicity (DLT) Occurring in Cycle 1 of the Phase I Portion of the Study

    Adverse event(s) that determined the treatment dose level was not tolerable for that patient in Cycle 1 of the Phase I portion of the study.

    Measured: Day 1 to 28 in the Phase I portion of the study

  2. Dose Limiting Toxicity Occurring in Cycle 1 of the Phase II Portion of the Study

    Adverse event(s) that determined the treatment dose level was not tolerable for that patient in Cycle 1 of the Phase II portion of the study.

    Measured: Day 1 to 28 in the Phase II portion of the study

Secondary outcomes (5)

  1. Unconfirmed Partial Response (UPR) Based on Response Criteria in Solid Tumors (RECIST)

    An unconfirmed partial response is defined as a partial response that has not been confirmed by a follow up CT scan (or MRI) at least 4 weeks after the criteria for response are first met. (A partial response is defined as an at least 30% reduction in the sum of the longest diameter of the target lesions. Non-target lesions must be at least stable)

    Measured: Every 57 days beginning with Cycle 3, or more frequently if appropriate

  2. Stable Disease (SD) as Best Response Based on Response Criteria in Solid Tumors (RECIST)

    Stable disease is defined as less than a radiographic partial response, but not progressive disease

    Measured: Every 57 days beginning with Cycle 3, or more frequently if appropriate

  3. Progressive Disease (PD) as Best Response Based on Response Criteria in Solid Tumors (RECIST)

    Progressive disease is defined as a ≥20% increase in the sum of the longest diameter, the appearance of one or more new lesions and/or unequivocal progression of non-target lesions by conventional or spiral CT or MRI

    Measured: Every 57 days beginning with Cycle 3, or more frequently if appropriate

  4. Disease Progression After Week 8 Based on Response Criteria in Solid Tumors (RECIST)

    First documentation of Progressive Disease (PD) occurring > 8 weeks on study.

    Measured: Every 57 days beginning with Cycle 3 (Week 8), or more frequently if appropriate

  5. Progression-free Survival

    Progression-free survival was measured from the start of the treatment to the time when the criteria for progression was met or death due to any cause (whichever is first recorded).

    Measured: Day 1 to disease progression or death

Timeline

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

  1. First posted10 Nov 2005 (estimated)
  2. Study startJan 2006
  3. Primary completionOct 2007
  4. Study completionOct 2007

Why it stopped: This trial is being closed based on lack of substantive efficacy, slow accrual and overall tolerance in patients treated to date.

Resources

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 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
23 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00251589
Sponsor's protocol ID
0683-025
Other IDs
MK0683-025, 2005_080
Status last verified
Feb 2015
First submitted
7 Nov 2005
Last updated
6 Mar 2015
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Vorinostat and erlotinib in people with Carcinoma, Non-Small-Cell Lung, 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 2 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 6 Mar 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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

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 10 Mar 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?

Dose Limiting Toxicity (DLT) Occurring in Cycle 1 of the Phase I Portion of the Study (time frame: Day 1 to 28 in the Phase I portion of the study). The study lists 2 primary outcomes in all. 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 NCT00251589.

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 6 Mar 2015.

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