Lung Cancer Clinical Trial

Zoledronic Acid and Positron Emission Tomography in Treating Patients With Advanced 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.

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Full 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.

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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

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

6

Study ID:

NCT00559897

Recruitment Status:

Terminated

Sponsor:

Barbara Ann Karmanos Cancer Institute

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There is 1 Location for this study

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Barbara Ann Karmanos Cancer Institute
Detroit Michigan, 48201, United States

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

6

Study ID:

NCT00559897

Recruitment Status:

Terminated

Sponsor:


Barbara Ann Karmanos Cancer Institute

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