Non-small Cell Lung CancerPhase 1/2NCT00516100
Bortezomib (Velcade) + Pemetrexed (Alimta) in Advanced NSCLC
A Phase 1/2 study testing bortezomib in people with Non-small Cell Lung Cancer, run by Aptium Oncology Research Network at 4 sites in United States.
Trial summary
Pemetrexed is an FDA-approved treatment for advanced lung cancer but the response rate is still very low. Bortezomib is currently approved to treat myeloma in patients who have already been treated. Currently, multiple studies are actively investigating how well bortezomib works with other drugs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- bortezomib
- How many people
- 62 participants
- Where
- 4 sitesUnited States
- Study dates
- Jan 2006to Aug 2012
- 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
- Unresectable locally advanced (Stage IIIB) or metastatic (Stage IV) NSCLC who have received one prior platinum-based chemotherapy regimen.
- One prior treatment with any biologically targeted agent is acceptable
- Stable, previously treated, brain metastases are allowed if clinically stable without steroid treatment for 10 days.
- ECOG performance status of 0 or 1.
- Measurable and/or evaluable indicator lesion(s).
- Adequate hematologic, renal and hepatic function
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- Patient is of a legally consenting age
- Patient has a life-expectancy >2 months.
- Voluntary written informed consent before performance of any study-related procedure
- Female patient is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control for the duration of the study.
- Male patient agrees to use an acceptable method for contraception for the duration of the study.
Who cannot join
- Prior treatment with pemetrexed (Alimta) or Bortezomib (Velcade).
- Patient was treated for another cancer within 3 years before enrollment, with the exception of basal cell carcinoma or cervical cancer in situ.
- Peripheral neuropathy NCI grade > 2.
- Symptomatic or uncontrolled brain metastasis.
- Radiation therapy to major bone marrow (> 10% of bone marrow) areas or to target lesions within 30 days prior to study entry.
- Patient has received other investigational drugs with 14 days before enrollment.
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- Serious medical or psychiatric illness likely to interfere with participation in this clinical study.
- Any systemic therapy within 21 days prior to study entry.
- Patient known to be human immunodeficiency virus (HIV)-positive.
- Patient had a significant cardiac event within 6 months of enrollment
- History of arrhythmia
- Congenital long QT syndrome or 1st degree relative with unexplained sudden death under 40 years of age.
- QT prolongation with other medications that required discontinuation of that medication.
- Presence of left bundle branch block (LBBB).
- QTc ≥480 msec or greater on screening ECG.
- Patient has hypersensitivity to bortezomib, boron or mannitol.
- Female patient is pregnant or breast-feeding.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Trinitas Comprehensive Cancer Center
Elizabeth, New Jersey, 07207
Cedars-Sinai Outpatient Cancer Center
Los Angeles, California, 90048
Comprehensive Cancer Center at Desert Regional Medical Center
Palm Springs, California, 92262
California Pacific Medical Center
San Francisco, California, 94115
About this study
Official title: Phase I/II Clinical Trial of Bortezomib (Velcade) + Pemetrexed (Alimta) in Previously Treated Patients With Advanced Non-Small Cell Lung Cancer
Pemetrexed is an FDA-approved treatment for advanced lung cancer but the response rate is still very low. Bortezomib is currently approved to treat myeloma in patients who have already been treated. Currently, multiple studies are actively investigating how well bortezomib works with other drugs. This study is testing how much bortezomib can be given to advanced lung cancer patients who have already received one treatment. This study will also see how well bortezomib and pemetrexed work together to treat lung cancer patients.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- bortezomib
- Keywords
- NSCLC
- 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.
bortezomibDrug
Also called Velcade (bortezomib), Alimta (pemetrexed)
MTD of bortezomib administered Days 1 and 8 plus 500 mg/m2 pemetrexed on day 1, every three weeks.
What is being measured
The primary outcome is the main question the study is designed to answer.
(Phase I)Maximum tolerated dose of bortezomib
Measured: Within 6 three-week cycles (18 weeks)
(Phase II)determine response rate, time to progression, one-year survival, and overall survival rates
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2007 (estimated)
- Study startJan 2006
- Primary completionJan 2010 (estimated)
- Study completionAug 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- 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
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aptium Oncology Research Network
- Sponsor type
- Research network
- Collaborators
- Millennium Pharmaceuticals, Inc.
- Investigators
- Ronald B. Natale, MD, Principal investigator, Cedars-Sinai Outpatient Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00516100
- Sponsor's protocol ID
- 05LUN01
- Status last verified
- Jan 2010
- First submitted
- 10 Aug 2007
- Last updated
- 15 Jan 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Clinical Trial of Bortezomib (Velcade) + Pemetrexed (Alimta) in Previously Treated Patients With Advanced Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00516100
- Acronym / sponsor ID
- 05LUN01
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- NSCLC
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Aptium Oncology Research NetworkResearch network
- Collaborators
- Millennium Pharmaceuticals, Inc.
- Study start
- Jan 2006
- Primary completion
- Jan 2010 (estimated)
- Study completion
- Aug 2012 (estimated)
- First posted
- 14 Aug 2007 (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.
Pemetrexed is an FDA-approved treatment for advanced lung cancer but the response rate is still very low. Bortezomib is currently approved to treat myeloma in patients who have already been treated. Currently, multiple studies are actively investigating how well bortezomib works with other drugs. This study is testing how much bortezomib can be given to advanced lung cancer patients who have already received one treatment. This study will also see how well bortezomib and pemetrexed work together to treat lung cancer patients.
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 (11 listed)
- Unresectable locally advanced (Stage IIIB) or metastatic (Stage IV) NSCLC who have received one prior platinum-based chemotherapy regimen.
- One prior treatment with any biologically targeted agent is acceptable
- Stable, previously treated, brain metastases are allowed if clinically stable without steroid treatment for 10 days.
- ECOG performance status of 0 or 1.
- Measurable and/or evaluable indicator lesion(s).
Key exclusion criteria (17 listed)
- Prior treatment with pemetrexed (Alimta) or Bortezomib (Velcade).
- Patient was treated for another cancer within 3 years before enrollment, with the exception of basal cell carcinoma or cervical cancer in situ.
- Peripheral neuropathy NCI grade > 2.
- Symptomatic or uncontrolled brain metastasis.
- Radiation therapy to major bone marrow (> 10% of bone marrow) areas or to target lesions within 30 days prior to study entry.
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 |
|---|---|---|
| bortezomibAlso: Velcade (bortezomib), Alimta (pemetrexed)MTD of bortezomib administered Days 1 and 8 plus 500 mg/m2 pemetrexed on day 1, every three weeks. | Drug | – |
Primary outcome
(Phase I)Maximum tolerated dose of bortezomib
Time frame: Within 6 three-week cycles (18 weeks)
(Phase II)determine response rate, time to progression, one-year survival, and overall survival rates
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2010.
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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.
Ronald B. Natale, MD principal investigator
Cedars-Sinai Outpatient Cancer Center
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing bortezomib in people with Non-small Cell Lung Cancer, run by Aptium Oncology Research Network at 4 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 11 inclusion and 17 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: status not confirmed, as of the sponsor's last update on 15 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 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?
Results are not available in the source record.
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?
(Phase I)Maximum tolerated dose of bortezomib (time frame: Within 6 three-week cycles (18 weeks)). 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?
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 15 Jan 2010.