Zoledronic Acid and Positron Emission Tomography in Treating Patients With Advanced Non-Small Cell Lung Cancer

This study has been terminated.
(Slow accrual)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Shirish Gadgeel, Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov Identifier:
NCT00559897
First received: November 15, 2007
Last updated: August 12, 2012
Last verified: August 2012

November 15, 2007
August 12, 2012
March 2008
April 2011   (final data collection date for primary outcome measure)
PET response rate [ Time Frame: FLT PET scan will be done 6-8 days after the dose of zoledronic acid ] [ Designated as safety issue: No ]
PET response rate
Complete list of historical versions of study NCT00559897 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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.

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.

Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
  • Lung Cancer
  • Metastatic Cancer
  • Other: 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.
  • Procedure: 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.
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.

Interventions:
  • Other: 3'-deoxy-3'-[18F]FLT
  • Procedure: Single photon emission computed tomography
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
5
April 2011
April 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00559897
CDR0000543463, P30CA022453, WSU-2006-136
Yes
Shirish Gadgeel, Barbara Ann Karmanos Cancer Institute
Barbara Ann Karmanos Cancer Institute
National Cancer Institute (NCI)
Study Chair: Shirish M. Gadgeel, MD Barbara Ann Karmanos Cancer Institute
Barbara Ann Karmanos Cancer Institute
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP