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Keep this study
Lead
Barbara Ann Karmanos Cancer Institute
With
National Cancer Institute (NCI)
OBJECTIVES:
* Determine the PET response rate after zoledronic acid in patients with non-small cell lung cancer.
OUTLINE: Patients receive 1 dose of zoledronic acid on day 1 followed by 3'-deoxy-3'-\[18F\]fluorothymidine/PET to determine standardized uptake value.
PROJECTED ACCRUAL: A total of 12 patients will be accrued for this study.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed non-small cell lung cancer
* Stage IIIB (with pleural effusion) or stage IV disease
Candidate for systemic therapy
Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques or ≥ 10 mm by spiral CT scan
No active brain metastases
* More than 7 days since prior radiotherapy for brain metastases
* Must be neurologically stable with no seizures within the past 3 weeks
PATIENT CHARACTERISTICS:
ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100%
WBC ≥ 3,000/mm³
ANC ≥ 1,500/mm³
Platelet count ≥ 100,000/mm³
Bilirubin ≤ 1.5 times upper limit of normal (ULN)
AST or ALT ≤ 2.5 times ULN (5 times ULN if liver metastases present)
Creatinine normal OR creatinine clearance ≥ 60 mL/min by Cockcroft-Gault formula
No current active dental problems, including infection of the teeth or jawbone (maxilla or mandible)
No dental or fixture trauma, or a current or prior diagnosis of osteonecrosis of the jaw, of exposed bone in the mouth, or of slow healing after dental procedures
Not pregnant
No uncontrolled intercurrent illness including, but not limited to, any of the following:
* Ongoing or active infection
* Symptomatic congestive heart failure
* Unstable angina pectoris
* Cardiac arrhythmia
* Psychiatric illness/social situations that would limit compliance with study requirements
PRIOR CONCURRENT THERAPY:
See Disease Characteristics
No prior or other concurrent bisphosphonates
More than 2 weeks since prior surgery
More than 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C) and recovered
More than 7 days since prior palliative radiotherapy and recovered
More than 6 weeks since prior and no planned dental or jaw surgery
More than 30 days since prior participation in an investigational trial
No other concurrent investigational agent
Clareo Health | Zoledronic Acid and Positron Emission Tomography in Treating Patients With Advanced Non-Small Cell Lung Cancer