Advanced Non-Small Cell Lung CancerPhase 1NCT00064636
Phase I Dose Escalation Study of VELCADE Plus Docetaxel in Patients With Advanced Non-Small Cell Lung Cancer or Other Solid Tumors
A Phase 1 study testing VELCADE TM (bortezomib) for Injection, or PS-341 in people with Advanced Non-Small Cell Lung Cancer and Other Solid Tumors, run by Millennium Pharmaceuticals, Inc..
Trial summary
The purpose of this study is to evaluate how safe VELCADE (PS-341) is when given with Taxotere (Docetaxel) to patients with non-small cell lung cancer or other solid tumors, 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
- Advanced Non-Small Cell Lung Cancer, Other Solid Tumors
- What is being tested?
- VELCADE TM (bortezomib) for Injection, or PS-341
- Type of treatment
- Injection or infusion
- How many people
- 46 participants
- Where
- No sites listed yet
- Study dates
- Dec 2002to not given
- Phase
- Phase 1
- 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
- Each patient must meet all of the following inclusion criteria to be enrolled in the study:
- Patient has histologically-confirmed advanced and/or metastatic NSCLC or other solid tumors, for which the patient is treatment-naïve or previously received up to two anti-neoplastic treatment regimens and for whom there is no known curative therapy. Patients enrolled at the Low- and High- Dose Expanded Cohorts must have a diagnosis of NSCLC in order to be eligible.
- Previous treatment with carboplatin or paclitaxel does not preclude enrollment in the study.
- Patient has measurable or evaluable disease. Patients enrolled at the expanded cohorts must have measurable disease according to the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines [1] presented in Table 3 and Table 4.
- Patient is 18 years of age or older.
- Patient has a Karnofsky performance status of 60% or higher.
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- Patient has a life expectancy of three months or longer.
- Patient has all of the following pretreatment laboratory data within 21 days of the first study drug dose:
- Absolute neutrophil count (ANC) greater than or equal to 1,500/mm3.
- Platelet count greater than or equal to 100,000/mm3.
- Hemoglobin greater than or equal to 8.0 g/dL.
- Serum creatinine less than or equal to 1.5 x the ULN:
- Patient has given voluntary written informed consent before performance of any study-related procedure not part of normal medical care.
- Female patient is post-menopausal, surgically sterilized, or willing to use acceptable methods of birth control (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) from the Screening visit through 90 days after the last study drug dose.
- Male patient agrees to use an acceptable barrier method for contraception from the Screening visit through 90 days after the last study drug dose.
Who cannot join
- Patients meeting any of the following exclusion criteria are not to be enrolled in the study.
- Patient previously received treatment with docetaxel.
- Patient previously received treatment with cisplatin at a cumulative dose >350 mg/m2.
- Patient has received chemotherapy within four weeks, nitrosoureas within six weeks, or antibody therapy within eight weeks of enrollment.
- Patient has received radiation therapy within four weeks of enrollment.
- Patient has a history of radiation therapy to >25% of bone marrow.
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- Patient has not recovered from all toxic effects of previous chemotherapy or radiation or antibody therapy.
- Patient has had any major surgery within four weeks of enrollment.
- Patient has a history of allergic reactions to appropriate diuretics or anti-emetics to be administered in conjunction with study drug.
- Patient has a history of severe hypersensitivity reaction to docetaxel or other agents formulated with polysorbate 80.
- Patient has electrocardiographic evidence of acute ischemia or new conduction system abnormalities.
- Patient has had a myocardial infarction within six months of enrollment.
- Patient has uncontrolled brain metastases or central nervous system disease.
- Patients with controlled brain metastases who are not receiving corticosteroids or anticonvulsants are eligible for study enrollment.
- Patient has Grade 2 or higher peripheral neuropathy
- Patient has leukemia or lymphoma.
- Patient has any of the following pretreatment laboratory data within 21 days before the first study drug dose:
- Total bilirubin > than the upper limit of normal (ULN).
- Alanine transaminase (ALT) and/or aspartate transaminase (AST) >1.5 x the ULN concurrent with alkaline phosphatase >2.5 x the ULN.
- Patient is HIV-infected.
- Patient is hepatitis B surface antigen positive or has previously documented hepatitis C
- Patient has an uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia.
- Patient has another serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocol.
- Female patient is pregnant or breast-feeding.
About this study
Official title: A Phase I, Open Label, Dose Escalation Study of PS-341 Plus Docetaxel in Treatment-Naive or Previously Treated Patients With Advanced Non-Small Cell Lung Cancer or Other Solid Tumors
The purpose of this study is to evaluate how safe VELCADE (PS-341) is when given with Taxotere (Docetaxel) to patients with non-small cell lung cancer or other solid tumors, and also to see what effects (good and bad) it has on you and your cancer.
Read the detailed description
This is a dose escalation study, which means that the first group of patients who enter the study will receive a low dose of VELCADE and Docetaxel. If the low dose of VELCADE and Docetaxel appears to be safe, then the next group of patients will receive a higher dose of VELCADE and docetaxel.
- Being tested
- VELCADE TM (bortezomib) for Injection, or PS-341
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VELCADE TM (bortezomib) for Injection, or PS-341Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2003 (estimated)
- Study startDec 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 46 participants
Sponsor and investigators
- Lead sponsor
- Millennium Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00064636
- Sponsor's protocol ID
- M34101-034
- Status last verified
- Sep 2003
- First submitted
- 10 Jul 2003
- Last updated
- 24 Jun 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open Label, Dose Escalation Study of PS-341 Plus Docetaxel in Treatment-Naive or Previously Treated Patients With Advanced Non-Small Cell Lung Cancer or Other Solid Tumors
- ClinicalTrials.gov ID
- NCT00064636
- Acronym / sponsor ID
- M34101-034
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 46 participants
- Lead sponsor
- Millennium Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2002
- First posted
- 11 Jul 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 safe VELCADE (PS-341) is when given with Taxotere (Docetaxel) to patients with non-small cell lung cancer or other solid tumors, and also to see what effects (good and bad) it has on you and your cancer.
Detailed description
This is a dose escalation study, which means that the first group of patients who enter the study will receive a low dose of VELCADE and Docetaxel. If the low dose of VELCADE and Docetaxel appears to be safe, then the next group of patients will receive a higher dose of VELCADE and docetaxel.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- 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 (15 listed)
- Each patient must meet all of the following inclusion criteria to be enrolled in the study:
- Patient has histologically-confirmed advanced and/or metastatic NSCLC or other solid tumors, for which the patient is treatment-naïve or previously received up to two anti-neoplastic treatment regimens and for whom there is no known curative therapy. Patients enrolled at the Low- and High- Dose Expanded Cohorts must have a diagnosis of NSCLC in order to be eligible.
- Previous treatment with carboplatin or paclitaxel does not preclude enrollment in the study.
- Patient has measurable or evaluable disease. Patients enrolled at the expanded cohorts must have measurable disease according to the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines [1] presented in Table 3 and Table 4.
- Patient is 18 years of age or older.
Key exclusion criteria (24 listed)
- Patients meeting any of the following exclusion criteria are not to be enrolled in the study.
- Patient previously received treatment with docetaxel.
- Patient previously received treatment with cisplatin at a cumulative dose >350 mg/m2.
- Patient has received chemotherapy within four weeks, nitrosoureas within six weeks, or antibody therapy within eight weeks of enrollment.
- Patient has received radiation therapy within four weeks of 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 TM (bortezomib) for Injection, or PS-341 | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2005.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing VELCADE TM (bortezomib) for Injection, or PS-341 in people with Advanced Non-Small Cell Lung Cancer and Other Solid Tumors, run by Millennium Pharmaceuticals, Inc..
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 15 inclusion and 24 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 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
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 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.
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. 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 24 Jun 2005.