Zoledronic Acid and Positron Emission Tomography in Treating Patients With Advanced Non-Small Cell Lung Cancer
Condition: Lung Cancer; Metastatic Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: 3'-deoxy-3'-[18F]FLT; Single photon emission computed tomography
Intervention description: Patient should receive the dose of zoledronic acid within 48 hours of the first FLT PET scan. The second FLT PET scan will be done 6-8 days after the dose of zoledronic acid.; Patient should receive the dose of zoledronic acid within 48 hours of the first FLT PET scan. The second FLT PET scan will be done 6-8 days after the dose of zoledronic acid.
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 6.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: bone metastases; stage IIIB non-small cell lung cancer; stage IV non-small cell lung cancer; recurrent non-small cell lung cancer

Summary:

      RATIONALE: A positron emission tomography scan is a procedure in which a small amount of
      radioactive sugar is injected into a vein, and a scanner is used to make detailed,
      computerized pictures of areas inside the body where tumor cells are found. This study is
      looking at whether the drug zoledronic acid interferes with the ability of a PET scan to find
      tumor cells.

      PURPOSE: This phase II trial is studying how well positron emission tomography works when
      given together with zoledronic acid in finding tumor cells in patients with advanced
      non-small cell lung cancer.
    

Eligibility criteria:

        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