Locally Advanced Non-small Cell Lung CancerPhase 1NSCLCNCT01059552
Treatment of Locally Advanced Non-Small Cell Lung Cancer (NSCLC)
A Phase 1 study testing vorinostat in people with Locally Advanced Non-small Cell Lung Cancer, run by Fox Chase Cancer Center at 3 sites in United States.
Trial summary
The purpose of this study is to determine the maximum tolerated dose of the combination of vorinostat, cisplatin, pemetrexed, and radiation therapy in patients with unresectable stage IIIA/IIIB non-small cell lung cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locally Advanced Non-small Cell Lung Cancer
- What is being tested?
- vorinostat
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 3 sitesUnited States
- Study dates
- 16 Dec 2009to 21 Oct 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- biopsy proven non-squamous NSCLC with unresectable stage IIIA or dry IIIB disease.
- FEV1 >/= 1 liter
- ECOG PS 0 or 1
- Able to swallow and absorb enterally
- Measurable disease per RECIST 1.1
- Adequate organ and marrow function including calculated creatinine clearance >/= 60 mL/min hepatic enzymes and alk phos </= 2.5 X ULN.
Who cannot join
- Chemotherapy or radiotherapy </= 4 weeks prior to registration (6 weeks for nitrosureas)
- Active bleeding
- Known brain mets
- Prior thoracic radiotherapy that would lead to overlap with current radiation field.
- More than 10% weight loss in 6 months.
- Pancoast tumors, supraclavicular or contralateral hilar lymph node involvement
- Known HIV positive
- Prior treatment with an HDAC inhibitor
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Medical University of South Carolina
Charleston, South Carolina, 29425
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
Moffitt Cancer Center
Tampa, Florida, 33612
About this study
Official title: Phase I Study of the HDAC Inhibitor Vorinostat With Chemotherapy and Radiation Therapy for Treatment of Locally Advanced Non-Small Cell Lung Cancer (NSCLC)
The purpose of this study is to determine the maximum tolerated dose of the combination of vorinostat, cisplatin, pemetrexed, and radiation therapy in patients with unresectable stage IIIA/IIIB non-small cell lung cancer.
Read the detailed description
This phase I trial will escalate doses of the histone deacetylase inhibitor (HDAC) vorinostat to a chemoradiation platform for cisplatin, pemetrexed and radiation to a dose of 70Gy in NSCLC patients with unresectable IIIA and dry IIIB disease. The endpoint will be to determine MTD of the combination.
- Being tested
- vorinostat
- Keywords
- lung cancer, locally advanced lung cancer
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vorinostatDrug
Also called Zolinza
vorinostat once daily for 12 weeks of therapy
| Study group | Role | What they receive |
|---|---|---|
| vorinostat | Experimental | Dose escalation of vorinostat, cisplatin, pemetrexed and radiation Receives: Drug: vorinostat |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess that safety and maximally tolerated dose of vorinostat in combination with chemoradiation for unresectable locally advanced NSCLC.
Measured: toxicity assessments will occur weekly
Secondary outcomes (3)
To investigate progression free survival.
Measured: CT/PET scans will be done after 12 weeks of therapy and at 12 week intervals until documented progression
To evaluate response rates with this combination
Measured: CT/PET will be done following 12 weeks of therapy.
To assess if pre-treatment tumor expression of TS, ERCC1 and HDAC1, 2, 3 are associated with response rate.
Measured: Archival tissue will be tested and correlated to response rates.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2010 (estimated)
- Study start16 Dec 2009
- Primary completion22 Jul 2015
- Study completion21 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Fox Chase Cancer CenterThe 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fox Chase Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Comprehensive Cancer Network
- Responsible party
- Sponsor
- Investigators
- Ranee Mehra, MD, Principal investigator, Fox Chase Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01059552
- Sponsor's protocol ID
- FER-TH-031
- Other IDs
- NCI-2010-01913
- Acronym
- NSCLC
- Status last verified
- Nov 2019
- First submitted
- 28 Jan 2010
- Last updated
- 27 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of the HDAC Inhibitor Vorinostat With Chemotherapy and Radiation Therapy for Treatment of Locally Advanced Non-Small Cell Lung Cancer (NSCLC)
- ClinicalTrials.gov ID
- NCT01059552
- Acronym / sponsor ID
- NSCLC / FER-TH-031
- Keywords
- lung cancer, locally advanced lung cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Fox Chase Cancer CenterUniversity, hospital or other
- Collaborators
- National Comprehensive Cancer Network
- Study start
- 16 Dec 2009 (actual)
- Primary completion
- 22 Jul 2015 (actual)
- Study completion
- 21 Oct 2019 (actual)
- First posted
- 1 Feb 2010 (estimated)
- Results
- Not posted in the source record
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 determine the maximum tolerated dose of the combination of vorinostat, cisplatin, pemetrexed, and radiation therapy in patients with unresectable stage IIIA/IIIB non-small cell lung cancer.
Detailed description
This phase I trial will escalate doses of the histone deacetylase inhibitor (HDAC) vorinostat to a chemoradiation platform for cisplatin, pemetrexed and radiation to a dose of 70Gy in NSCLC patients with unresectable IIIA and dry IIIB disease. The endpoint will be to determine MTD of the combination.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| vorinostat | Experimental | Drug: vorinostatDose escalation of vorinostat, cisplatin, pemetrexed and radiation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- biopsy proven non-squamous NSCLC with unresectable stage IIIA or dry IIIB disease.
- FEV1 >/= 1 liter
- ECOG PS 0 or 1
- Able to swallow and absorb enterally
- Measurable disease per RECIST 1.1
Key exclusion criteria (8 listed)
- Chemotherapy or radiotherapy </= 4 weeks prior to registration (6 weeks for nitrosureas)
- Active bleeding
- Known brain mets
- Prior thoracic radiotherapy that would lead to overlap with current radiation field.
- More than 10% weight loss in 6 months.
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 once daily for 12 weeks of therapy | Drug | vorinostat |
Primary outcome
To assess that safety and maximally tolerated dose of vorinostat in combination with chemoradiation for unresectable locally advanced NSCLC.
Time frame: toxicity assessments will occur weekly
3 secondary outcomes
To investigate progression free survival.
Time frame: CT/PET scans will be done after 12 weeks of therapy and at 12 week intervals until documented progression
To evaluate response rates with this combination
Time frame: CT/PET will be done following 12 weeks of therapy.
To assess if pre-treatment tumor expression of TS, ERCC1 and HDAC1, 2, 3 are associated with response rate.
Time frame: Archival tissue will be tested and correlated to response rates.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2019.
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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.
Ranee Mehra, MD principal investigator
Fox Chase Cancer Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing vorinostat in people with Locally Advanced Non-small Cell Lung Cancer, run by Fox Chase Cancer Center at 3 sites in United States.
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 6 inclusion and 8 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 27 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To assess that safety and maximally tolerated dose of vorinostat in combination with chemoradiation for unresectable locally advanced NSCLC. (time frame: toxicity assessments will occur weekly). 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 27 Nov 2019.