Adenocarcinoma of the LungPhase 2NCT00118144
Bortezomib in Treating Patients With Stage IIIB or Stage IV Lung Cancer
A Phase 2 study testing bortezomib in people with Adenocarcinoma of the Lung and Bronchoalveolar Cell Lung Cancer, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
This phase II trial is studying how well bortezomib works in treating patients with stage IIIB or stage IV lung cancer. Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adenocarcinoma of the Lung, Bronchoalveolar Cell Lung Cancer, Non-small Cell Lung Cancer
- What is being tested?
- bortezomib
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2005to Dec 2010
- 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
Criteria:
- Histologically confirmed bronchoalveolar carcinoma (BAC) or adenocarcinoma of the lung with BAC features:
- Stage IIIB or IV disease:
- Patients with stage IIIB disease must be ineligible for definitive combined modality treatment with radiotherapy and chemotherapy
- Measurable disease, defined as >= 1 unidimensionally measurable lesion >= 20 mm by conventional techniques or >= 10 mm by spiral CT scan:
- Previously irradiated lesions are considered measurable only if lesion progressed after completion of radiotherapy
- No unstable brain metastases:
- Brain metastases that are stable for ≥ 1 month after completion of prior radiotherapy, stereotactic surgery, or surgery are allowed
- Performance status:
- ECOG 0-2
- Life expectancy >3 months
- Hepatic:
- Bilirubin normal
- AST and ALT =< 2.5 times upper limit of normal
- Renal:
- Creatinine normal OR creatinine clearance >= 60 mL/min
- Cardiovascular:
- No symptomatic congestive heart failure
- No unstable angina pectoris
- No cardiac arrhythmias
- No more than 1 prior chemotherapy regimen for advanced BAC:
- Prior gefitinib or other known epidermal growth factor receptor (EGFR) inhibitors are not considered a systemic chemotherapy regimen
- At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
- At least 4 weeks since prior corticosteroids
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception before, during, and for 30 days after completion of study treatment
- No ongoing or active infection
- No other malignancy within the past 3 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer that is in complete remission
- No peripheral neuropathy >= grade 2
- No known hypersensitivity to bortezomib, boron, or mannitol
- No psychiatric illness or social situation that would preclude study compliance
- No other uncontrolled illness
- No concurrent routine granulocyte colony-stimulating factors (e.g., filgrastim [G-CSF] or sargramostim [GM-CSF])
- At least 2 weeks since prior radiotherapy
- Recovered from prior therapy (alopecia allowed)
- At least 2 weeks since prior EGFR inhibitors
- At least 4 weeks since prior anticonvulsants
- No prior bortezomib
- No concurrent antiretroviral therapy for HIV-positive patients
- No other concurrent investigational agents
- No other concurrent anticancer therapy
- Concurrent bisphosphonates for bone metastases allowed
- Hematopoietic:
- Absolute neutrophil count >= 1,500/mm3
- Platelet count >= 100,000/mm3
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Study of Bortezomib (PS-341) for Patients With Advanced Bronchiolo-Alveolar Carcinoma (BAC) or Adenocarcinoma With BAC Features
This phase II trial is studying how well bortezomib works in treating patients with stage IIIB or stage IV lung cancer. Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Read the detailed description
PRIMARY OBJECTIVES:
- Determine the objective response rate in patients with stage IIIB or IV bronchoalveolar carcinoma (BAC) or adencarcinoma of the lung with BAC features treated with bortezomib.
SECONDARY OBJECTIVES:
- Determine the progression-free and overall survival of patients treated with this drug.
II. Determine the time to disease progression in patients treated with this drug.
III. Determine predictors of response, based on molecular correlative studies of tumor and blood, in patients with treated with this drug.
OUTLINE: This is a multicenter study. Patients are stratified according to prior epidermal growth factor receptor inhibitor therapy (yes vs no).
Patients receive bortezomib IV over 3-5 seconds on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed for survival.
- Conditions
- Adenocarcinoma of the Lung, Bronchoalveolar Cell Lung Cancer, Non-small Cell Lung Cancer, Recurrent Non-small Cell Lung Cancer, Stage IIIB Non-small Cell Lung Cancer, Stage IV Non-small Cell Lung Cancer
- Being tested
- bortezomib
- Medical subject headings
- Adenocarcinoma of Lung, Adenocarcinoma, Bronchiolo-Alveolar, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bortezomibDrug
Given IV
| Study group | Role | What they receive |
|---|---|---|
| Arm I | Experimental | Patients receive bortezomib IV over 3-5 seconds on days 1 and 8. Receives: Drug: bortezomib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate With Bortezomib Evaluated by Both RECIST Criteria and Computer-assisted Image Analysis.
A response rate of 20% or more with bortezomib would be of interest for further evaluation, whereas a response rate of less than 5% would be of no interest. Response defined as a confirmed CR or PR.
Measured: Up to 5 years
Secondary outcomes (2)
Progression-free Survival
Progression Free Survival using the product-limit method of Kaplan and Meier
Measured: Up to 5 years
Overall Survival
Overall Suvival using the product-limit method of Kaplan and Meier.
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2005 (estimated)
- Study startJun 2005
- Primary completionDec 2010
- Study completionDec 2010
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 Adenocarcinoma of the LungStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The 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
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- David Gandara, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00118144
- Sponsor's protocol ID
- NCI-2009-00113
- Other IDs
- NCI-2009-00113, CDR0000433404, PHII-57, 7003, N01CM62208, N01CM62201, N01CM62209, N01CM62207
- Status last verified
- Apr 2013
- First submitted
- 8 Jul 2005
- Last updated
- 21 Aug 2014
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Bortezomib (PS-341) for Patients With Advanced Bronchiolo-Alveolar Carcinoma (BAC) or Adenocarcinoma With BAC Features
- ClinicalTrials.gov ID
- NCT00118144
- Acronym / sponsor ID
- NCI-2009-00113
- Conditions
- Adenocarcinoma of the Lung, Bronchoalveolar Cell Lung Cancer, Non-small Cell Lung Cancer, Recurrent Non-small Cell Lung Cancer, Stage IIIB Non-small Cell Lung Cancer, Stage IV Non-small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Jun 2005
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 11 Jul 2005 (estimated)
- Results
- Posted 21 Aug 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase II trial is studying how well bortezomib works in treating patients with stage IIIB or stage IV lung cancer. Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Detailed description
PRIMARY OBJECTIVES:
- Determine the objective response rate in patients with stage IIIB or IV bronchoalveolar carcinoma (BAC) or adencarcinoma of the lung with BAC features treated with bortezomib.
SECONDARY OBJECTIVES:
- Determine the progression-free and overall survival of patients treated with this drug.
II. Determine the time to disease progression in patients treated with this drug.
III. Determine predictors of response, based on molecular correlative studies of tumor and blood, in patients with treated with this drug.
OUTLINE: This is a multicenter study. Patients are stratified according to prior epidermal growth factor receptor inhibitor therapy (yes vs no).
Patients receive bortezomib IV over 3-5 seconds on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed for survival.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm I | Experimental | Drug: bortezomibPatients receive bortezomib IV over 3-5 seconds on days 1 and 8. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| bortezomibGiven IV | Drug | Arm I |
Primary outcome
Objective Response Rate With Bortezomib Evaluated by Both RECIST Criteria and Computer-assisted Image Analysis.
Time frame: Up to 5 years
A response rate of 20% or more with bortezomib would be of interest for further evaluation, whereas a response rate of less than 5% would be of no interest. Response defined as a confirmed CR or PR.
2 secondary outcomes
Progression-free Survival
Time frame: Up to 5 years
Overall Survival
Time frame: Up to 5 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2014.
- 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.
David Gandara principal investigator
City of Hope Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing bortezomib in people with Adenocarcinoma of the Lung and Bronchoalveolar Cell Lung Cancer, run by National Cancer Institute (NCI) at 1 site 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?
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 21 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 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 Aug 2014). 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?
Objective Response Rate With Bortezomib Evaluated by Both RECIST Criteria and Computer-assisted Image Analysis. (time frame: Up to 5 years). 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 21 Aug 2014.