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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)

Status
Terminated
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00559897
Enrollment
6
Registered
2007-11-16
Start date
2008-03-31
Completion date
2011-04-30
Last updated
2015-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer, Metastatic Cancer

Keywords

bone metastases, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer, recurrent non-small cell lung cancer

Brief 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.

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.

Interventions

OTHER3'-deoxy-3'-[18F]FLT

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.

PROCEDURESingle photon emission computed tomography

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.

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Barbara Ann Karmanos Cancer Institute
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
PET Response RateFLT PET scan will be done 6-8 days after the dose of zoledronic acid

Countries

United States

Participant flow

Participants by arm

ArmCount
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. 3'-deoxy-3'-\[18F\]FLT: 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 hours of the first FLT PET scan. The second FLT PET scan will be done 6-8 days after the dose of zoledronic acid.
6
Total6

Baseline characteristics

Characteristic3'-Deoxy-3'-[18F]FLT PET & Zoledronic Acid
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
1 Participants
Age, Categorical
Between 18 and 65 years
5 Participants
Region of Enrollment
United States
6 participants
Sex: Female, Male
Female
2 Participants
Sex: Female, Male
Male
4 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
— / —
other
Total, other adverse events
0 / 6
serious
Total, serious adverse events
1 / 6

Outcome results

Primary

PET Response Rate

Time frame: FLT PET scan will be done 6-8 days after the dose of zoledronic acid

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026