Lung CancerPhase 1/2NCT00313690
Cancer Treatment Followed by Surgery for Early Stage Non-small Cell Lung Cancer
A Phase 1/2 study testing Bortezomib, Docetaxel and Cisplatin in people with Lung Cancer, run by University of Southern California.
Trial summary
The purpose of the phase I portion of the study is to determine the safety and feasibility of neoadjuvant bortezomib in combination with docetaxel and cisplatin followed by surgery in early stage non-small cell lung cancer, via a multi-cohort dose escalation trial. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Bortezomib, Docetaxel and Cisplatin
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Apr 2006to not given
- Phase
- Phase 1/2
- 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
- Both men and women of all ethnic groups are eligible for this trial if they meet the eligibility criteria. To date, there is no information that suggests differences in drug metabolism or disease response would be expected in one group compared to another. All efforts will be made to accrue a representative sample. If differences in outcome appear to be associated with gender or ethnicity, then perhaps a follow-up study can be designed to investigate these differences more fully. The catchment's area for USC is Los Angeles County.
Who cannot join
- Subjects must not be receiving nor plan on receiving any other investigational agents.
- Patients with a history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80.
- History of known allergy to compounds of similar chemical or biologic composition to bortezomib or other agents used in this study (i.e. Boron, Mannitol).
- Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, congestive heart failure or myocardial infarction within the preceding 6 months, symptomatic cardiac arrhythmia, unstable angina pectoris, psychiatric illness or social situations that would limit compliance with study prescribed therapy.
- Because patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy, HIV-positive patients are excluded from the study.
- Pregnant or nursing women
- Peripheral neuropathy: greater than grade 1
About this study
Official title: Phase I/II Study of Neoadjuvant Bortezomib in Combination With Docetaxel and Cisplatin Followed by Surgery in Early Stage Non-Small Cell Lung Cancer.
- The purpose of the phase I portion of the study is to determine the safety and feasibility of neoadjuvant bortezomib in combination with docetaxel and cisplatin followed by surgery in early stage non-small cell lung cancer, via a multi-cohort dose escalation trial.
- The phase II portion of the study will look at the clinical response rate and the pathology response rate. Other purposes are to look at surgical morbidity, mortality and respectability rates. Molecular correlates of response and survival to this neoadjuvant regimen will be explored.
- Conditions
- Lung Cancer
- Being tested
- Bortezomib, Docetaxel and Cisplatin
- Keywords
- 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.
Bortezomib, Docetaxel and CisplatinDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2006 (estimated)
- Study startApr 2006
Why it stopped: Recruitment difficulties
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Investigators
- Barbara Gitlitz, MD, Principal investigator, USC Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00313690
- Sponsor's protocol ID
- 2N-05-2
- Status last verified
- May 2014
- First submitted
- 10 Apr 2006
- Last updated
- 21 May 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Study of Neoadjuvant Bortezomib in Combination With Docetaxel and Cisplatin Followed by Surgery in Early Stage Non-Small Cell Lung Cancer.
- ClinicalTrials.gov ID
- NCT00313690
- Acronym / sponsor ID
- 2N-05-2
- Conditions
- Lung Cancer
- Keywords
- Lung Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Recruitment difficulties
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Study start
- Apr 2006
- First posted
- 12 Apr 2006 (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 the phase I portion of the study is to determine the safety and feasibility of neoadjuvant bortezomib in combination with docetaxel and cisplatin followed by surgery in early stage non-small cell lung cancer, via a multi-cohort dose escalation trial.
- The phase II portion of the study will look at the clinical response rate and the pathology response rate. Other purposes are to look at surgical morbidity, mortality and respectability rates. Molecular correlates of response and survival to this neoadjuvant regimen will be explored.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Both men and women of all ethnic groups are eligible for this trial if they meet the eligibility criteria. To date, there is no information that suggests differences in drug metabolism or disease response would be expected in one group compared to another. All efforts will be made to accrue a representative sample. If differences in outcome appear to be associated with gender or ethnicity, then perhaps a follow-up study can be designed to investigate these differences more fully. The catchment's area for USC is Los Angeles County.
Key exclusion criteria (7 listed)
- Subjects must not be receiving nor plan on receiving any other investigational agents.
- Patients with a history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80.
- History of known allergy to compounds of similar chemical or biologic composition to bortezomib or other agents used in this study (i.e. Boron, Mannitol).
- Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, congestive heart failure or myocardial infarction within the preceding 6 months, symptomatic cardiac arrhythmia, unstable angina pectoris, psychiatric illness or social situations that would limit compliance with study prescribed therapy.
- Because patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy, HIV-positive patients are excluded from the study.
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 |
|---|---|---|
| Bortezomib, Docetaxel and Cisplatin | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2014.
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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.
Barbara Gitlitz, MD principal investigator
USC Comprehensive Cancer Center
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Bortezomib, Docetaxel and Cisplatin in people with Lung Cancer, run by University of Southern California.
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 1 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: withdrawn, as of the sponsor's last update on 21 May 2014. 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?
The study was withdrawn before enrolling participants, so there are no results.
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.
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 21 May 2014.