Carcinoma, Non-Small-Cell LungPhase 2NCT00117351
VELCADE in Previously Treated Patients With Stage IIIB and IV Bronchioloalveolar Carcinoma (BAC) and Adenocarcinoma With BAC Features
A Phase 2 study testing VELCADE in people with Carcinoma, Non-Small-Cell Lung and Adenocarcinoma, Bronchiolo-Alveolar, run by Millennium Pharmaceuticals, Inc. at 1 site in United States.
Trial summary
This study will evaluate the safety and efficacy of VELCADE in patients with previously treated stage IIIB and IV bronchioloalveolar carcinoma and adenocarcinoma with bronchioloalveolar features. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung, Adenocarcinoma, Bronchiolo-Alveolar
- What is being tested?
- VELCADE
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Apr 2005to Jul 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
- Have histologically or cytologically confirmed BAC or adenocarcinoma with BAC features.
- Have stage IIIB (malignant pleural effusion) or stage IV disease.
- Have progressed on or after receipt of 1 to 2 prior lines of chemotherapy, one of which must be an EGFR TKI (Iressa or Tarceva). Adjuvant chemotherapy will NOT be counted as a prior line of therapy.
- Have radiographic documentation of progressive disease (PD) as determined by the investigator.
- Have measurable disease by RECIST.
- Are 18 years of age or older.
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- Have a life expectancy greater than 3 months.
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
- Are able to provide written informed consent in accordance with all applicable regulations and follow the study procedures.
- Patients must be capable of understanding the investigational nature and potential risks and benefits.
Who cannot join
- Have had chemotherapy (or an EGFR TKI) 4 weeks prior to enrollment.
- Have peripheral neuropathy of Grade 2 or greater intensity, as defined by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE 3.0).
- Have been previously treated with VELCADE.
- Have experienced myocardial infarction within 6 months prior to enrollment or have New York Hospital Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities.
- Have had radiation therapy within 4 weeks prior to enrollment.
- Have had monoclonal antibody therapy within 4 weeks prior to enrollment.
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- Have had any major surgery within 4 weeks prior to enrollment.
- Have inadequate organ function at the Screening visit as defined by laboratory testing
- Have symptomatic brain metastases or brain metastases that have not responded to radiation therapy, local or systemic chemotherapy, or were not completely resected by stereotactic surgery or other surgical modalities, or have significant post treatment brain edema.
- Have uncontrolled active systemic infection requiring treatment.
- Have had treatment for a cancer other than BAC within 5 years prior to enrollment, with the exception of basal cell carcinoma or cervical cancer in situ.
- Have a history of allergic reaction attributable to compounds containing boron or mannitol or hypersensitivity reactions to drugs formulated with polysorbate 80.
- Have known human immunodeficiency virus (HIV)-positive or hepatitis B surface antigen-positive status or known active hepatitis C infection. Patients assessed by the investigator to be at risk for HIV, hepatitis B or C infection should be tested in accordance with local regulations.
- Have poorly controlled hypertension, diabetes mellitus, or another serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocol.
- Are a pregnant or breast-feeding female. Confirmation that the patient is not pregnant must be established by a negative serum β-human chorionic gonadotropin (β-hCG) pregnancy test result obtained during the screening period. Pregnancy testing is not required for post-menopausal or surgically sterilized women.
- Are unwilling to employ adequate means of contraception (condoms, diaphragm, birth control pills, injections, intrauterine device, or abstinence).
- Are currently receiving or have previously received an investigational agent for any reason within 4 weeks of enrollment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Open-Label, Phase 2 Study of VELCADE (Bortezomib) for Injection in Previously Treated Patients With Stage IIIB and IV Bronchioloalveolar Carcinoma and Adenocarcinoma With Bronchioloalveolar Features
This study will evaluate the safety and efficacy of VELCADE in patients with previously treated stage IIIB and IV bronchioloalveolar carcinoma and adenocarcinoma with bronchioloalveolar features.
Read the detailed description
Bronchioloalveolar carcinoma (BAC) and adenocarcinoma with bronchioloalveolar features are distinct subtypes of non-small-cell lung cancer which are difficult to treat in advanced stages. This study will determine the safety and efficacy of VELCADE therapy in patients with advanced BAC or adenocarcinoma with BAC features who have failed epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI) therapy.
- Being tested
- VELCADE
- Keywords
- Adenocarcinoma, Bronchiolo-Alveolar, Carcinoma, Bronchioloalveolar, Carcinoma, Non-Small-Cell Lung, Carcinoma, Bronchiolo-Alveolar
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Adenocarcinoma, Bronchiolo-Alveolar, Adenocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VELCADEDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2005 (estimated)
- Study startApr 2005
- Primary completionJun 2007
- Study completionJul 2007
Why it stopped: insufficient efficacy
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Non-Small-Cell LungStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Millennium Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00117351
- Sponsor's protocol ID
- C05002
- Status last verified
- Feb 2011
- First submitted
- 30 Jun 2005
- Last updated
- 17 Feb 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-Label, Phase 2 Study of VELCADE (Bortezomib) for Injection in Previously Treated Patients With Stage IIIB and IV Bronchioloalveolar Carcinoma and Adenocarcinoma With Bronchioloalveolar Features
- ClinicalTrials.gov ID
- NCT00117351
- Acronym / sponsor ID
- C05002
- Keywords
- Adenocarcinoma, Bronchiolo-Alveolar, Carcinoma, Bronchioloalveolar, Carcinoma, Non-Small-Cell Lung, Carcinoma, Bronchiolo-Alveolar
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: insufficient efficacy
- Lead sponsor
- Millennium Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2005
- Primary completion
- Jun 2007 (actual)
- Study completion
- Jul 2007 (actual)
- First posted
- 6 Jul 2005 (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.
This study will evaluate the safety and efficacy of VELCADE in patients with previously treated stage IIIB and IV bronchioloalveolar carcinoma and adenocarcinoma with bronchioloalveolar features.
Detailed description
Bronchioloalveolar carcinoma (BAC) and adenocarcinoma with bronchioloalveolar features are distinct subtypes of non-small-cell lung cancer which are difficult to treat in advanced stages. This study will determine the safety and efficacy of VELCADE therapy in patients with advanced BAC or adenocarcinoma with BAC features who have failed epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI) therapy.
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 (10 listed)
- Have histologically or cytologically confirmed BAC or adenocarcinoma with BAC features.
- Have stage IIIB (malignant pleural effusion) or stage IV disease.
- Have progressed on or after receipt of 1 to 2 prior lines of chemotherapy, one of which must be an EGFR TKI (Iressa or Tarceva). Adjuvant chemotherapy will NOT be counted as a prior line of therapy.
- Have radiographic documentation of progressive disease (PD) as determined by the investigator.
- Have measurable disease by RECIST.
Key exclusion criteria (17 listed)
- Have had chemotherapy (or an EGFR TKI) 4 weeks prior to enrollment.
- Have peripheral neuropathy of Grade 2 or greater intensity, as defined by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE 3.0).
- Have been previously treated with VELCADE.
- Have experienced myocardial infarction within 6 months prior to enrollment or have New York Hospital Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities.
- Have had radiation therapy within 4 weeks prior to enrollment.
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 | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early (reason given: insufficient efficacy). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2011.
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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 in people with Carcinoma, Non-Small-Cell Lung and Adenocarcinoma, Bronchiolo-Alveolar, run by Millennium Pharmaceuticals, Inc. 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?
The sponsor lists 10 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: stopped early, as of the sponsor's last update on 17 Feb 2011. 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?
The study was stopped early (reason given: insufficient efficacy). 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.
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 17 Feb 2011.