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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00559897
Recruitment Status : Terminated (Slow accrual)
First Posted : November 16, 2007
Results First Posted : February 4, 2015
Last Update Posted : February 4, 2015
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Shirish Gadgeel, Barbara Ann Karmanos Cancer Institute

Study Description
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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.


Condition or disease Intervention/treatment Phase
Lung Cancer Metastatic Cancer Other: 3'-deoxy-3'-[18F]FLT Procedure: Single photon emission computed tomography Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: 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)
Study Start Date : March 2008
Actual Primary Completion Date : April 2010
Actual Study Completion Date : April 2011

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.

 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.


Outcome Measures
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Primary Outcome Measures :
  1. PET Response Rate [ Time Frame: FLT PET scan will be done 6-8 days after the dose of zoledronic acid ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00559897


Locations
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United States, Michigan
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201-1379
Sponsors and Collaborators
Barbara Ann Karmanos Cancer Institute
National Cancer Institute (NCI)
Investigators
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Study Chair: Shirish M. Gadgeel, MD Barbara Ann Karmanos Cancer Institute
More Information
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Responsible Party: Shirish Gadgeel, Principal Investigator, Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov Identifier: NCT00559897    
Other Study ID Numbers: CDR0000543463
P30CA022453 ( U.S. NIH Grant/Contract )
WSU-2006-136 ( Other Identifier: Karmanos Cancer Institute )
First Posted: November 16, 2007    Key Record Dates
Results First Posted: February 4, 2015
Last Update Posted: February 4, 2015
Last Verified: January 2015
Keywords provided by Shirish Gadgeel, Barbara Ann Karmanos Cancer Institute:
bone metastases
stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer
recurrent non-small cell lung cancer
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
 Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms