Phase II Study Evaluating the Effect of Zolendronic Acid on Standardized Uptake Value (SUV) on FLT PET Scans in Non-Small Cell Lung Cancer (NSCLC)
Inclusion 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