Non-Small Cell Lung CancerPhase 2NCT00343720
Study of Alimta® (Pemetrexed) Plus VELCADE® (Bortezomib) or Alimta Alone or VELCADE Alone in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Failed Prior Therapy
A Phase 2 study testing VELCADE and Alimta in people with Non-Small Cell Lung Cancer, run by Millennium Pharmaceuticals, Inc. at 1 site in Belgium.
Trial summary
The purpose of this study is to establish the objective response rate (complete response + partial response), following treatment with Alimta plus VELCADE, Alimta alone, or VELCADE alone in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have failed prior preventative therapy for… 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?
- VELCADE and Alimta
- How many people
- Not given
- Where
- 1 siteBelgium
- Study dates
- Start not givento Oct 2007
- Phase
- Phase 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
- Men or women, 18 years of age or older
- Non-small cell lung cancer (NSCLC) has been histologically or cytologically confirmed
- Has relapsed or refractory locally advanced (Stage IIIb) or metastatic (Stage IV) NSCLC
- Failed one prior line of systemic antineoplastic therapy for Stage IIIb/IV NSCLC (one additional prior line allowed if given as neoadjuvant, or adjuvant therapy to tumor resection)
- Subject must have documented progressive disease (PD) since previous systemic antineoplastic therapy
- Has measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) criteria
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- Has an ECOG performance status score of 0 or 1
- Has a life expectancy greater than 3 months
- Female subjects must be postmenopausal (for at least 6 months), surgically sterile, abstinent, or, if sexually active, be practicing an effective method of birth control (e.g., prescription oral contraceptives, contraceptive injections, intrauterine device, double-barrier method, contraceptive patch, male partner sterilization) before entry and throughout the study; and have a negative serum or urine β-human chorionic gonadotropin (hCG) pregnancy test at screening.
- Subjects (or their legally acceptable representatives) must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to and able to comply with the protocol requirements and participate in the study before any study-related procedure not part of normal medical care is conducted.
- In countries where health authorities have approved the pharmacogenomic and protein testing, subjects (or their legally acceptable representatives) must have signed an informed consent for testing indicating that they agree to participate in the genetic part and protein testing part of the study; participation in the genetic and protein testing component is mandatory for testing, but optional for future research.
Who cannot join
- Has peripheral neuropathy of Grade 2 or greater intensity, as defined by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE Version 3.0)
- Previous treatment with VELCADE or Alimta
- Has received 2 or more prior lines of antineoplastic therapies for Stage IIIb/IV NSCLC
- Any prior systemic antineoplastic therapy for NSCLC (i.e., prior chemotherapy, radiation therapy, prior monoclonal antibodies or any investigational drug or any major surgery) within 4 weeks before randomization
- Has had significant weight loss (documented equal to or greater than 10% body weight in the 6 weeks before randomization)
- Inadequate organ function at the screening visit as defined by the following laboratory values:
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- Platelet count equal to or less than 100 × 10^9/L
- Hemoglobin equal to or less than 8.0 g/dL (80 g/L)
- Absolute neutrophil count (ANC) equal to or less than 1.5 × 10^9/L
- AST equal to or greater than 3 times the upper limit of the normal range (ULN) or greater than 5 times the ULN for subjects with liver metastases
- ALT equal to or greater than 3 times ULN
- Calculated creatinine clearance equal to or greater than 45 mL/min
- Total bilirubin equal to or greater than 1.5 times ULN
- Myocardial infarction within 6 months before randomization or has New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities
- Central nervous system metastasis or brain metastases that have not been completely resected or completely eliminated by radiation therapy and/or chemotherapy, or clinical or radiographic evidence that they have recurred. Subjects with a history of brain metastases are required to have had a brain computed tomography (CT) or magnetic resonance imaging (MRI) scan conducted within 1 month of enrollment to verify the continuing absence of brain metastases.
- Uncontrolled pleural effusion (defined as more than 2 pleuracentesis within 4 weeks of the randomization)
- Active systemic infection requiring treatment
- Inability to interrupt aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs) for a 5-day period (8-day period for long-acting agents, such as piroxicam)
- Unable or unwilling to take corticosteroids
- Other malignancy within the past 5 years. Exceptions for the following if treated and not active:
- basal cell or nonmetastatic squamous cell carcinoma of the skin;
- cervical carcinoma in situ; or
- International Federation of Gynecology and Obstetrics (FIGO) Stage 1 carcinoma of the cervix
- History of allergic reaction attributable to compounds containing boron or mannitol
- Is pregnant or breast-feeding
- Currently enrolled in another clinical research study or has received an investigational agent for any reason within 4 weeks before randomization
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open-Label, Multicenter Study of Alimta® (Pemetrexed) Plus VELCADE® (Bortezomib) or Alimta Alone or VELCADE Alone in Subjects With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Failed Prior Antineoplastic Therapy
The purpose of this study is to establish the objective response rate (complete response + partial response), following treatment with Alimta plus VELCADE, Alimta alone, or VELCADE alone in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have failed prior preventative therapy for Stage IIIb/IV NSCLC. The Alimta alone treatment group will be used as the control. The VELCADE single-agent treatment group will be used to determine if VELCADE administered weekly can demonstrate response rates.
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- VELCADE, Alimta
- Keywords
- VELCADE, Alimta, locally advanced, metastatic, non-small cell lung cancer, complete response, partial response, Locally Advanced or Metastatic Non-Small Cell Lung Cancer
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Neoplasm Metastasis, Pathologic Complete Response
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VELCADEDrug
AlimtaDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2006 (estimated)
- Primary completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Millennium Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00343720
- Sponsor's protocol ID
- JNJ-26866138-LUC-2001
- Status last verified
- Mar 2008
- First submitted
- 22 Jun 2006
- Last updated
- 13 Mar 2008
- Results posted
- No
Publications
Scagliotti GV, Germonpre P, Bosquee L, Vansteenkiste J, Gervais R, Planchard D, Reck M, De Marinis F, Lee JS, Park K, Biesma B, Gans S, Ramlau R, Szczesna A, Makhson A, Manikhas G, Morgan B, Zhu Y, Chan KC, von Pawel J. A randomized phase II study of bortezomib and pemetrexed, in combination or alone, in patients with previously treated advanced non-small-cell lung cancer. Lung Cancer. 2010 Jun;68(3):420-6. doi: 10.1016/j.lungcan.2009.07.011. Epub 2009 Aug 18.
PubMed 19692142
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-Label, Multicenter Study of Alimta® (Pemetrexed) Plus VELCADE® (Bortezomib) or Alimta Alone or VELCADE Alone in Subjects With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Failed Prior Antineoplastic Therapy
- ClinicalTrials.gov ID
- NCT00343720
- Acronym / sponsor ID
- JNJ-26866138-LUC-2001
- Conditions
- Non-Small Cell Lung Cancer
- Keywords
- VELCADE, Alimta, locally advanced, metastatic, non-small cell lung cancer, complete response, partial response, Locally Advanced or Metastatic Non-Small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Millennium Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Primary completion
- Oct 2007 (actual)
- First posted
- 23 Jun 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 this study is to establish the objective response rate (complete response + partial response), following treatment with Alimta plus VELCADE, Alimta alone, or VELCADE alone in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have failed prior preventative therapy for Stage IIIb/IV NSCLC. The Alimta alone treatment group will be used as the control. The VELCADE single-agent treatment group will be used to determine if VELCADE administered weekly can demonstrate response rates.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Men or women, 18 years of age or older
- Non-small cell lung cancer (NSCLC) has been histologically or cytologically confirmed
- Has relapsed or refractory locally advanced (Stage IIIb) or metastatic (Stage IV) NSCLC
- Failed one prior line of systemic antineoplastic therapy for Stage IIIb/IV NSCLC (one additional prior line allowed if given as neoadjuvant, or adjuvant therapy to tumor resection)
- Subject must have documented progressive disease (PD) since previous systemic antineoplastic therapy
Key exclusion criteria (26 listed)
- Has peripheral neuropathy of Grade 2 or greater intensity, as defined by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE Version 3.0)
- Previous treatment with VELCADE or Alimta
- Has received 2 or more prior lines of antineoplastic therapies for Stage IIIb/IV NSCLC
- Any prior systemic antineoplastic therapy for NSCLC (i.e., prior chemotherapy, radiation therapy, prior monoclonal antibodies or any investigational drug or any major surgery) within 4 weeks before randomization
- Has had significant weight loss (documented equal to or greater than 10% body weight in the 6 weeks before randomization)
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 |
|---|---|---|
| VELCADE | Drug | – |
| Alimta | Drug | – |
Primary outcome
Not reported in the source record.
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 13 Mar 2008.
- Derived from this study: PubMed 19692142Scagliotti GV, Germonpre P, Bosquee L, Vansteenkiste J, Gervais R, Planchard D, Reck M, De Marinis F, Lee JS, Park K, Biesma B, Gans S, Ramlau R, Szczesna A, Makhson A, Manikhas G, Morgan B, Zhu Y, Chan KC, von Pawel J. A randomized phase II study of bortezomib and pemetrexed, in combination or alone, in patients with previously treated advanced non-small-cell lung cancer. Lung Cancer. 2010 Jun;68(3):420-6. doi: 10.1016/j.lungcan.2009.07.011. Epub 2009 Aug 18.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 VELCADE and Alimta in people with Non-Small Cell Lung Cancer, run by Millennium Pharmaceuticals, Inc. at 1 site in Belgium.
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 26 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 Mar 2008. 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 Belgium. 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?
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00343720, which also lists 1 linked publication.
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 Mar 2008.