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| ID | Type | Description | Link |
|---|---|---|---|
| BCC-LUN-04-002 | Other Identifier | James Graham Brown Cancer Center Clinical Trials Office |
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funding discontinued by sponsor
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| Name | Class |
|---|---|
| James Graham Brown Cancer Center | OTHER |
| Novartis Pharmaceuticals | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| zoledronic acid | Experimental | 3.0-4.0 mg by IV (in the vein), once a month for 6 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| zoledronic acid | Drug | 3.0-4.0 mg by IV (in the vein), once a month for 6 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | TRAP levels at Baseline and 2 weeks after first Zometa infusion |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Goetz H Kloecker, MD, MSPH | James Graham Brown Cancer Center/ University of Louisville | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| James Graham Brown Cancer Center | Louisville | Kentucky | 40202 | United States |
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| Label | URL |
|---|---|
| James Graham Brown Cancer Center | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Zoledronic Acid | 3.0-4.0 mg by IV (in the vein), once a month for 6 months |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Zoledronic Acid | 3.0-4.0 mg by IV (in the vein), once a month for 6 months |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | 13 of 28 total study participants could not be evaluated: 7 due to sample deterioration; 5 participant non-compliance; 1 withdrew. | Posted | Mean | Full Range | Percent change | TRAP levels at Baseline and 2 weeks after first Zometa infusion |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Zoledronic Acid | 3.0-4.0 mg by IV (in the vein), once a month for 6 months |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Goetz H Kloecker, MD | James Graham Brown Cancer Center, University of Louisville | 502-562-4358 | ghkloe01@louisville.edu |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D055752 | Small Cell Lung Carcinoma |
| D009362 | Neoplasm Metastasis |
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
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| ID | Term |
|---|---|
| D000077211 | Zoledronic Acid |
| ID | Term |
|---|---|
| D004164 | Diphosphonates |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
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| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| 0 |
| 28 |
| 0 |
| 28 |
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| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007093 |
| Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |