Carcinoma, Non-Small Cell LungPhase 2NCT00265200
Using TRAP to Evaluate the Effect of Zometa on Bone Metastasis Due to Lung Cancer
A Phase 2 study testing zoledronic acid in people with Carcinoma, Non-Small Cell Lung and Carcinoma, Small Cell Lung, run by University of Louisville at 1 site in United States.
Trial summary
The purpose of this study is to evaluate a new blood test as a way to follow the effect of Zometa in treating bone metastases due to lung cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Non-Small Cell Lung, Carcinoma, Small Cell Lung, Metastases
- What is being tested?
- zoledronic acid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2005to Dec 2010
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- invasive lung cancer (small cell or non-small cell lung cancer)
- osteolytic bone metastasis determined by clinical exam, bone scan/XR
- age > 18 years
Who cannot join
- concurrent malignancy with a second primary
- renal failure (serum creatinine > 3mg/dl)
- pregnancy
- active rheumatoid arthritis
- intolerance to zoledronic acid
Trial locations and contacts
1 site in 1 country.
United States1 site
James Graham Brown Cancer Center
Louisville, Kentucky, 40202
About this study
Official title: Bone Metabolic Markers, TRAP, and Zometa's Effect on Bone Metastasis Due to Lung Cancer
The purpose of this study is to evaluate a new blood test as a way to follow the effect of Zometa in treating bone metastases due to lung cancer.
Read the detailed description
The purpose of this research study is to evaluate a new blood test as a way to follow the effect of Zometa in treating bone metastases. The blood test will look for a protein, called TRAP, which is released into the blood stream by the breakdown of bone. This study will compare the TRAP blood test with other blood tests for bone destruction.
- Being tested
- zoledronic acid
- Keywords
- Zometa, bone metastasis, lung cancer, non-small cell lung cancer, small cell lung cancer, bone metabolic markers, tartrate resistant acid phosphatase
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Small Cell Lung Carcinoma, Neoplasm Metastasis, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
zoledronic acidDrug
Also called Zometa
3.0-4.0 mg by IV (in the vein), once a month for 6 months
| Study group | Role | What they receive |
|---|---|---|
| zoledronic acid | Experimental | 3.0-4.0 mg by IV (in the vein), once a month for 6 months Receives: Drug: zoledronic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average Percent Change From Baseline in TRAP Levels at 2 Weeks
Change was calculated as 100% (value at baseline minus value at 2 weeks)/value at baseline
Measured: TRAP levels at Baseline and 2 weeks after first Zometa infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2005 (estimated)
- Study startFeb 2005
- Primary completionAug 2009
- Study completionDec 2010
Why it stopped: funding discontinued by sponsor
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Carcinoma, Non-Small Cell LungStudies of the same condition, open and under way.
- More trials run by University of LouisvilleThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Louisville
- Sponsor type
- University, hospital or other
- Collaborators
- James Graham Brown Cancer Center, Novartis Pharmaceuticals
- Responsible party
- Principal investigator, Goetz Kloecker, James Graham Brown Cancer Center
- Investigators
- Goetz H Kloecker, MD, MSPH, Principal investigator, James Graham Brown Cancer Center/ University of Louisville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00265200
- Sponsor's protocol ID
- 565.04
- Other IDs
- BCC-LUN-04-002
- Status last verified
- Mar 2018
- First submitted
- 12 Dec 2005
- Last updated
- 5 Mar 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bone Metabolic Markers, TRAP, and Zometa's Effect on Bone Metastasis Due to Lung Cancer
- ClinicalTrials.gov ID
- NCT00265200
- Acronym / sponsor ID
- 565.04
- Keywords
- Zometa, bone metastasis, lung cancer, non-small cell lung cancer, small cell lung cancer, bone metabolic markers, tartrate resistant acid phosphatase
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: funding discontinued by sponsor
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University of LouisvilleUniversity, hospital or other
- Collaborators
- James Graham Brown Cancer Center, Novartis Pharmaceuticals
- Study start
- Feb 2005
- Primary completion
- Aug 2009 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 14 Dec 2005 (estimated)
- Results
- Posted 6 Apr 2017
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 a new blood test as a way to follow the effect of Zometa in treating bone metastases due to lung cancer.
Detailed description
The purpose of this research study is to evaluate a new blood test as a way to follow the effect of Zometa in treating bone metastases. The blood test will look for a protein, called TRAP, which is released into the blood stream by the breakdown of bone. This study will compare the TRAP blood test with other blood tests for bone destruction.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| zoledronic acid | Experimental | Drug: zoledronic acid3.0-4.0 mg by IV (in the vein), once a month for 6 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- invasive lung cancer (small cell or non-small cell lung cancer)
- osteolytic bone metastasis determined by clinical exam, bone scan/XR
- age > 18 years
Key exclusion criteria (5 listed)
- concurrent malignancy with a second primary
- renal failure (serum creatinine > 3mg/dl)
- pregnancy
- active rheumatoid arthritis
- intolerance to zoledronic acid
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 |
|---|---|---|
| zoledronic acidAlso: Zometa3.0-4.0 mg by IV (in the vein), once a month for 6 months | Drug | zoledronic acid |
Primary outcome
Average Percent Change From Baseline in TRAP Levels at 2 Weeks
Time frame: TRAP levels at Baseline and 2 weeks after first Zometa infusion
Change was calculated as 100% (value at baseline minus value at 2 weeks)/value at baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- James Graham Brown Cancer CenterLink provided by the sponsor.
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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.
Goetz H Kloecker, MD, MSPH principal investigator
James Graham Brown Cancer Center/ University of Louisville
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 zoledronic acid in people with Carcinoma, Non-Small Cell Lung and Carcinoma, Small Cell Lung, run by University of Louisville 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 3 inclusion and 5 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 5 Mar 2018. 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?
Yes. Results are posted in the registry (first posted 6 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Average Percent Change From Baseline in TRAP Levels at 2 Weeks (time frame: TRAP levels at Baseline and 2 weeks after first Zometa infusion). 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 5 Mar 2018; AzTrials last refreshed its copy on 2 Nov 2026.