Carcinoma, Non-Small Cell Lung, Carcinoma, Small Cell Lung, Metastases
Conditions
Keywords
Zometa, bone metastasis, lung cancer, non-small cell lung cancer, small cell lung cancer, bone metabolic markers, tartrate resistant acid phosphatase
Brief 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.
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.
Interventions
DRUGzoledronic acid
3.0-4.0 mg by IV (in the vein), once a month for 6 months
Sponsors
James Graham Brown Cancer Center
Novartis Pharmaceuticals
University of Louisville
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* invasive lung cancer (small cell or non-small cell lung cancer) * osteolytic bone metastasis determined by clinical exam, bone scan/XR * age \> 18 years
Exclusion criteria
* concurrent malignancy with a second primary * renal failure (serum creatinine \> 3mg/dl) * pregnancy * active rheumatoid arthritis * intolerance to zoledronic acid
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average Percent Change From Baseline in TRAP Levels at 2 Weeks | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Zoledronic Acid 3.0-4.0 mg by IV (in the vein), once a month for 6 months | 28 |
| Total | 28 |
Baseline characteristics
| Characteristic | Zoledronic Acid |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 6 Participants |
| Age, Categorical Between 18 and 65 years | 22 Participants |
| Region of Enrollment United States | 28 participants |
| Sex: Female, Male Female | 16 Participants |
| Sex: Female, Male Male | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 28 |
| serious Total, serious adverse events | 0 / 28 |
Outcome results
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
Time frame: TRAP levels at Baseline and 2 weeks after first Zometa infusion
Population: 13 of 28 total study participants could not be evaluated: 7 due to sample deterioration; 5 participant non-compliance; 1 withdrew.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Zoledronic Acid | Average Percent Change From Baseline in TRAP Levels at 2 Weeks | NTx | 37.3 Percent change |
| Zoledronic Acid | Average Percent Change From Baseline in TRAP Levels at 2 Weeks | TRAP-5b | 44.9 Percent change |
| Zoledronic Acid | Average Percent Change From Baseline in TRAP Levels at 2 Weeks | bALP | 12.9 Percent change |