Using TRAP to Evaluate the Effect of Zometa on Bone Metastasis Due to Lung Cancer

• Sponsor: University of Louisville (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00265200
• Collaborator: James Graham Brown Cancer Center (Other), Novartis Pharmaceuticals (Industry)
• Enrollment: 28
• Location: 1
• Arm: 1
• Duration (Months): 69.9
• Patients Per Site Per Month: 0.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Carcinoma, Non-Small Cell Lung; Carcinoma, Small Cell Lung; Metastases	Drug: zoledronic acid	Phase 2

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

• Study Type: Interventional
• Actual Enrollment: 28 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Bone Metabolic Markers, TRAP, and Zometa's Effect on Bone Metastasis Due to Lung Cancer
• Study Start Date: Feb 1, 2005
• Actual Primary Completion Date: Aug 1, 2009
• Actual Study Completion Date: Dec 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: zoledronic acid 3.0-4.0 mg by IV (in the vein), once a month for 6 months	Drug: zoledronic acid; 3.0-4.0 mg by IV (in the vein), once a month for 6 months; Other Names: Zometa

Outcome Measures

Primary Outcome Measures

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	James Graham Brown Cancer Center	Louisville	Kentucky	United States	40202

Sponsors and Collaborators

• University of Louisville
• James Graham Brown Cancer Center
• Novartis Pharmaceuticals

Investigators

• Principal Investigator: Goetz H Kloecker, MD, MSPH, James Graham Brown Cancer Center/ University of Louisville

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• James Graham Brown Cancer Center

Publications

None provided.

• Responsible Party: Goetz Kloecker, Assoc Professor, James Graham Brown Cancer Center
• ClinicalTrials.gov Identifier: NCT00265200
• Other Study ID Numbers: 565.04; BCC-LUN-04-002
• First Posted: Dec 14, 2005
• Last Update Posted: Mar 5, 2018
• Last Verified: Mar 1, 2018

• Keywords provided by Goetz Kloecker, Assoc Professor, James Graham Brown Cancer Center: Zometa; bone metastasis; lung cancer; non-small cell lung cancer; small cell lung cancer; bone metabolic markers; tartrate resistant acid phosphatase
• Additional relevant MeSH terms: Carcinoma; Lung Neoplasms; Neoplasm Metastasis; Neoplasms, Second Primary; Carcinoma, Non-Small-Cell Lung; Carcinoma, Small Cell; Small Cell Lung Carcinoma; Zoledronic Acid

Study Results

Participant Flow

Arm/Group Title	Zoledronic Acid
Arm/Group Description	3.0-4.0 mg by IV (in the vein), once a month for 6 months
Period Title: Overall Study
STARTED	28
COMPLETED	24
NOT COMPLETED	4

Baseline Characteristics

Arm/Group Title	Zoledronic Acid
Arm/Group Description	3.0-4.0 mg by IV (in the vein), once a month for 6 months
Overall Participants	28
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	22 78.6%
>=65 years	6 21.4%
Sex: Female, Male (Count of Participants)
Female	16 57.1%
Male	12 42.9%
Region of Enrollment (participants) [Number]
United States	28 100%

Outcome Measures

1. Primary Outcome

Title	Average Percent Change From Baseline in TRAP Levels at 2 Weeks
Description	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

Outcome Measure Data

Analysis Population Description

13 of 28 total study participants could not be evaluated: 7 due to sample deterioration; 5 participant non-compliance; 1 withdrew.

Arm/Group Title	Zoledronic Acid
Arm/Group Description	3.0-4.0 mg by IV (in the vein), once a month for 6 months
Measure Participants	15
NTx	37.3
TRAP-5b	44.9
bALP	12.9

Adverse Events

Arm/Group Title	Zoledronic Acid
Arm/Group Description	3.0-4.0 mg by IV (in the vein), once a month for 6 months
All Cause Mortality
	Zoledronic Acid
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Zoledronic Acid
	Affected / at Risk (%)	# Events
Total	0/28 (0%)
Other (Not Including Serious) Adverse Events
	Zoledronic Acid
	Affected / at Risk (%)	# Events
Total	0/28 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.