Zoledronic Acid and Positron Emission Tomography in Treating Patients With Advanced Non-Small Cell Lung Cancer
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)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Michigan
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Detroit, Michigan, United States, 48201-1379
- Barbara Ann Karmanos Cancer Institute
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: 3'-deoxy-3'-[18F]FLT PET & 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 Single photon emission computed tomography. Patient should receive the dose of zoledronic acid within 48 hrs of the first '3'-deoxy-3'-[18F]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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
PET Response Rate
Time Frame: FLT PET scan will be done 6-8 days after the dose of zoledronic acid
|
FLT PET scan will be done 6-8 days after the dose of zoledronic acid
|
Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CDR0000543463
- P30CA022453 (U.S. NIH Grant/Contract)
- WSU-2006-136 (Other Identifier: Karmanos Cancer Institute)
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