Non-Small Cell Lung CancerPhase 2NCT00051974
Phase 2 Study of VELCADE Alone or VELCADE® Plus Docetaxel in Previously Treated Patients With Advanced Non-Small Cell Lung Cancer
A Phase 2 study testing VELCADE™ (bortezomib) for Injection (formerly PS-341) in people with Non-Small Cell Lung Cancer, run by Millennium Pharmaceuticals, Inc. at 20 sites in United States.
Trial summary
The purpose of this study is to evaluate how tumors in patients with non-small cell lung cancer respond to treatment with VELCADE alone versus VELCADE given with docetaxel and also to see what effects (good and bad) it has on you and your cancer. 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™ (bortezomib) for Injection (formerly PS-341)
- Type of treatment
- Injection or infusion
- How many people
- 155 participants
- Where
- 20 sitesUnited States
- Study dates
- Dec 2002to Sep 2004
- 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
- Inoperable, locally advanced (Stage IIIB) or metastatic (Stage IV) NSCLC that has been histologically or cytologically confirmed.
- No more than 1 prior chemotherapy regimen.
- 18 years of age or older.
- Measurable or evaluable disease.
- KPS ≥70%.
- Life expectancy greater than 3 months.
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- Female patient is either post-menopausal, 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 of birth control for the duration of the study.
- Provide written informed consent before any study-related procedure not part of normal medical care is conducted.
- Willing and able to comply with the protocol requirements.
Who cannot join
- Peripheral neuropathy of Grade 2 or greater intensity, as defined by the NCI Common Toxicity Criteria (CTC):
- Grade 2: Objective sensory loss or paresthesia (including tingling), interfering with function, but not interfering with activities of daily living (ADLs).
- Grade 3: Sensory loss or paresthesia interfering with ADLs.
- Grade 4: Permanent sensory loss that interferes with function.
- Previous treatment with VELCADE.
- Previous treatment with docetaxel (prior treatment with paclitaxel will be allowed).
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- Chemotherapy within 4 weeks prior to enrollment.
- Radiation therapy within 4 weeks prior to enrollment.
- Monoclonal antibodies within 6 weeks prior to enrollment.
- Any major surgery within 4 weeks prior to enrollment.
- Inadequate organ function at the Screening visit as defined by the following laboratory values:
- Platelet count ≤100,000 x 109/L
- Hemoglobin ≤8.0 g/dL
- Absolute neutrophil count (ANC) ≤1.5 x 109/L
- Aspartate transaminase (AST) ≥3 x the upper limit of the normal range (ULN)
- Alanine transaminase (ALT) ≥3 times ULN
- Creatinine ≥1.8 mg/dL
- Total bilirubin ≥2 times ULN
- Myocardial infarction within 6 months prior to enrollment or has 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. Prior to study entry, any ECG abnormality at Screening has to be documented by the investigator as not medically relevant.
- No history of brain metastases or central nervous system disease.
- Active systemic infection requiring treatment.
- Treatment for a cancer other than NSCLC within 5 years prior to enrollment, with the exception of basal cell carcinoma or cervical cancer in situ.
- History of allergic reaction attributable to compounds containing boron or mannitol.
- Known to be human immunodeficiency virus (HIV)-positive. Patients assessed by the investigator to be at risk for HIV infection should be tested in accordance with local regulations.
- Known to be hepatitis B surface antigen-positive or has known active hepatitis C infection. Patients assessed by the investigator to be at risk for hepatitis B or C infection should be tested in accordance with local regulations.
- 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.
- Pregnant or breast-feeding female patient. 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.
- Currently enrolled in another clinical research study or has received an investigational agent for any reason within 4 weeks of enrollment.
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
United States20 sites
Winship Cancer Institute
Atlanta, Georgia, 30322
University of Colorado Health Sciences Center
Aurora, Colorado, 80010
U of Alambama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, 35294
Mass. General Hospital Hem/Onc. Associates
Boston, Massachusetts, 02114
Carolinas Hematology-Oncology Associates
Charlotte, North Carolina, 28203
Atlanta VAMC
Decatur, Georgia, 30033
Duke University Medical Center
Durham, North Carolina, 27710
Univeristy of Florida Shands Cancer Center
Gainesville, Florida, 32610
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
DBA Kansas City Cancer Centers
Kansas City, Missouri, 64154
Cedars-Sinai Comprehensive Cancer Center
Los Angeles, California, 90048
UCLA Medical Center Thoracic Malignancy
Los Angeles, California, 90095
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, 53792
Sylvester Comprehensive Cancer Center
Miami, Florida, 33136
Vanderbilt University-Clinical Trials Center
Nashville, Tennessee, 37232
Yale University School Of Medicine
New Haven, Connecticut, 06520
Kimmel Cancer Center at Jefferson
Philadelphia, Pennsylvania, 19107
Hunstman Cancer Institute-University of Utah
Salt Lake City, Utah, 84112
St. Louis University Health Sciences Center
St Louis, Missouri, 63110
Washington University, Barnard Cancer Center
St Louis, Missouri, 63110
About this study
Official title: A Randomized, Multicenter, Open-Label, Phase 2 Study of VELCADE Alone or VELCADE Plus Docetaxel in Previously Treated Patients With Advanced Non-Small Cell Lung Cancer
The purpose of this study is to evaluate how tumors in patients with non-small cell lung cancer respond to treatment with VELCADE alone versus VELCADE given with docetaxel and also to see what effects (good and bad) it has on you and your cancer.
Read the detailed description
In this study, patients with non-small cell lung cancer that is no longer responding to standard medical treatment with another anti-cancer drug will be randomly chosen to receive treatment with VELCADE alone or VELCADE in combination with docetaxel. Patients have almost equal chance of getting into either of the two treatment arms listed above.
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- VELCADE™ (bortezomib) for Injection (formerly PS-341)
- 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.
VELCADE™ (bortezomib) for Injection (formerly PS-341)Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2003 (estimated)
- Study startDec 2002
- Primary completionSep 2004
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 155 participants
Sponsor and investigators
- Lead sponsor
- Millennium Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00051974
- Sponsor's protocol ID
- M34102-048
- Status last verified
- Feb 2008
- First submitted
- 21 Jan 2003
- Last updated
- 11 Feb 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Multicenter, Open-Label, Phase 2 Study of VELCADE Alone or VELCADE Plus Docetaxel in Previously Treated Patients With Advanced Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00051974
- Acronym / sponsor ID
- M34102-048
- Conditions
- Non-Small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 155 participants
- Lead sponsor
- Millennium Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2002
- Primary completion
- Sep 2004 (actual)
- First posted
- 22 Jan 2003 (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 evaluate how tumors in patients with non-small cell lung cancer respond to treatment with VELCADE alone versus VELCADE given with docetaxel and also to see what effects (good and bad) it has on you and your cancer.
Detailed description
In this study, patients with non-small cell lung cancer that is no longer responding to standard medical treatment with another anti-cancer drug will be randomly chosen to receive treatment with VELCADE alone or VELCADE in combination with docetaxel. Patients have almost equal chance of getting into either of the two treatment arms listed above.
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 (10 listed)
- Inoperable, locally advanced (Stage IIIB) or metastatic (Stage IV) NSCLC that has been histologically or cytologically confirmed.
- No more than 1 prior chemotherapy regimen.
- 18 years of age or older.
- Measurable or evaluable disease.
- KPS ≥70%.
Key exclusion criteria (28 listed)
- Peripheral neuropathy of Grade 2 or greater intensity, as defined by the NCI Common Toxicity Criteria (CTC):
- Previous treatment with VELCADE.
- Previous treatment with docetaxel (prior treatment with paclitaxel will be allowed).
- Chemotherapy within 4 weeks prior to enrollment.
- 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™ (bortezomib) for Injection (formerly PS-341) | 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 11 Feb 2008.
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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.
20 sites 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™ (bortezomib) for Injection (formerly PS-341) in people with Non-Small Cell Lung Cancer, run by Millennium Pharmaceuticals, Inc. at 20 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 10 inclusion and 28 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 11 Feb 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 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 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?
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 11 Feb 2008.