Carcinoma, Non Small Cell LungPhase 2NCT00798720
Vorinostat and Bortezomib as Third-line Treatment in Advanced Non-small Cell Lung Cancer
A Phase 2 study testing vorinostat and bortezomib in people with Carcinoma, Non Small Cell Lung, run by University of Wisconsin, Madison.
Trial summary
The purpose of this study is to evaluate the efficacy of vorinostat and bortezomib in the third line treatment of advanced NSCLC, as well as to assess toxicity (including neuropathy) and tolerability of this regimen. 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 bortezomib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- Dec 2008to Oct 2012
- Phase
- Phase 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
- Pathologically/histologically confirmed NSCLC
- Advance NSCLC (stage IIIB w/ effusion, stage IV, or recurrent disease)
- Measurable disease
- Two prior systemic anti-cancer (cytotoxic or biologic) regimens for advanced/metastatic disease, including one (1) platinum-based chemotherapy
- Prior treatment allowed if side effects have resolved and 3 weeks has passed since last dose of treatment (1 week for palliative radiation therapy)
- ECOG performance status 0, 1, or 2
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- Patients with brain metastases are allowed, if clinically stable after treatment
- Normal liver, kidney, and marrow function
- 18 years of age or older
- Negative pregnancy test for women of child-bearing potential.
- Life expectancy 3 months or more
- No concurrent use of other antitumor agents
Who cannot join
- Prior therapy with vorinostat, HDAC inhibitors, or bortezomib
- Pre-existing neuropathy grade >/= 2
- Myocardial infarction within 6 months prior to enrollment or have NY Heart Association Class III or Class IV heart failure
- Have taken valproic acid </= 4 weeks prior to enrollment
- Previous or current malignancies of other histologies within the past 5 years, except cervical carcinoma in situ and adequately treated basal cell or squamous cell carcinoma of the skin
- Hypersensitivity to bortezomib, boron, or mannitol
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- Serious medical or psychiatric illness likely to interfere with participation in the clinical study
- Pregnant women
- HIV positive patients
- Hepatitis infection (HCV or HBV) patients
About this study
Official title: Phase II Study of Vorinostat (SAHA, Zolinza) and Bortezomib (PS341, Velcade) as Third-Line Treatment in Patients With Advanced Non-Small Cell Lung Cancer
The purpose of this study is to evaluate the efficacy of vorinostat and bortezomib in the third line treatment of advanced NSCLC, as well as to assess toxicity (including neuropathy) and tolerability of this regimen.
Read the detailed description
Current treatment for non-small cell lung cancer (NSCLC) remains inadequate. Vorinostat is a novel agent that inhibits the enzymatic activity of histone deacetylases (HDACs). Bortezomib is a small molecule proteasome inhibitor. Preclinical and clinical studies have shown the advantages of combining these two agents in the treatment of NSCLC
- Conditions
- Carcinoma, Non Small Cell Lung
- Being tested
- vorinostat, bortezomib
- Keywords
- non small cell lung cancer, HDAC, proteasome inhibitor
- 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 SAHA, Zolinza
400 mg by mouth once daily for days 1-14 of each 21 day cycle
bortezomibDrug
Also called PS341, Velcade
1.3 mg/m2 IV on days 1, 4, 8, 11 of each 21 day cycle
| Study group | Role | What they receive |
|---|---|---|
| Vorinostat + Bortezomib | Experimental | Vorinostat 400 mg + Bortezomib 1.3 mg/m2 Receives: Drug: vorinostat; Drug: bortezomib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Three-month Progression-free Survival
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST), as a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since the treatment started or the appearance of one or more new lesions."
Measured: Three-months post-treatment
Secondary outcomes (3)
Response Rate
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) for target lesions and assessed by MRI, CT, or chest x-ray: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR+PR.
Measured: Until disease progression, up to 2 years
Median Overall Survival
Measured: 5 years
Toxicity
Graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0
Measured: 30 days post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2008 (estimated)
- Study startDec 2008
- Primary completionOct 2012
- Study completionOct 2012
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.
- Other trials for Carcinoma, Non Small Cell LungStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- Millennium Pharmaceuticals, Inc., Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Tien Hoang, M.D., Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00798720
- Sponsor's protocol ID
- CO08502
- Other IDs
- H-2008-0229, A534260, SMPH\MEDICINE\HEM-ONC, NCI-2011-00811
- Status last verified
- Sep 2016
- First submitted
- 25 Nov 2008
- Last updated
- 13 Dec 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Vorinostat (SAHA, Zolinza) and Bortezomib (PS341, Velcade) as Third-Line Treatment in Patients With Advanced Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00798720
- Acronym / sponsor ID
- CO08502
- Conditions
- Carcinoma, Non Small Cell Lung
- Keywords
- non small cell lung cancer, HDAC, proteasome inhibitor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- Millennium Pharmaceuticals, Inc., Merck Sharp & Dohme LLC
- Study start
- Dec 2008
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 26 Nov 2008 (estimated)
- Results
- Posted 21 Nov 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the efficacy of vorinostat and bortezomib in the third line treatment of advanced NSCLC, as well as to assess toxicity (including neuropathy) and tolerability of this regimen.
Detailed description
Current treatment for non-small cell lung cancer (NSCLC) remains inadequate. Vorinostat is a novel agent that inhibits the enzymatic activity of histone deacetylases (HDACs). Bortezomib is a small molecule proteasome inhibitor. Preclinical and clinical studies have shown the advantages of combining these two agents in the treatment of NSCLC
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vorinostat + Bortezomib | Experimental | Drug: vorinostat, Drug: bortezomibVorinostat 400 mg + Bortezomib 1.3 mg/m2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Pathologically/histologically confirmed NSCLC
- Advance NSCLC (stage IIIB w/ effusion, stage IV, or recurrent disease)
- Measurable disease
- Two prior systemic anti-cancer (cytotoxic or biologic) regimens for advanced/metastatic disease, including one (1) platinum-based chemotherapy
- Prior treatment allowed if side effects have resolved and 3 weeks has passed since last dose of treatment (1 week for palliative radiation therapy)
Key exclusion criteria (10 listed)
- Prior therapy with vorinostat, HDAC inhibitors, or bortezomib
- Pre-existing neuropathy grade >/= 2
- Myocardial infarction within 6 months prior to enrollment or have NY Heart Association Class III or Class IV heart failure
- Have taken valproic acid </= 4 weeks prior to enrollment
- Previous or current malignancies of other histologies within the past 5 years, except cervical carcinoma in situ and adequately treated basal cell or squamous cell carcinoma of the skin
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: SAHA, Zolinza400 mg by mouth once daily for days 1-14 of each 21 day cycle | Drug | Vorinostat + Bortezomib |
| bortezomibAlso: PS341, Velcade1.3 mg/m2 IV on days 1, 4, 8, 11 of each 21 day cycle | Drug | Vorinostat + Bortezomib |
Primary outcome
Three-month Progression-free Survival
Time frame: Three-months post-treatment
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST), as a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since the treatment started or the appearance of one or more new lesions."
3 secondary outcomes
Response Rate
Time frame: Until disease progression, up to 2 years
Median Overall Survival
Time frame: 5 years
Toxicity
Time frame: 30 days post-treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Tien Hoang, M.D. principal investigator
University of Wisconsin, Madison
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing vorinostat and bortezomib in people with Carcinoma, Non Small Cell Lung, run by University of Wisconsin, Madison.
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 12 inclusion and 10 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: finished, as of the sponsor's last update on 13 Dec 2019. 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 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.
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 21 Nov 2016). 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?
Three-month Progression-free Survival (time frame: Three-months post-treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Dec 2019.