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

Lung Cancer Clinical Trial

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00559897
• Other study ID #: CDR0000543463
• Secondary ID: P30CA022453WSU-2
• Status: Terminated
• Phase: Phase 2
• First received: November 15, 2007
• Last updated: January 26, 2015
• Start date: March 2008
• Est. completion date: April 2011

Study information

• Verified date: January 2015
• Source: Barbara Ann Karmanos Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: April 2011
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Neoplasms
• Metastatic Cancer
• Neoplasm Metastasis

Intervention

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.

Locations

Country	Name	City	State
United States	Barbara Ann Karmanos Cancer Institute	Detroit	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Barbara Ann Karmanos Cancer Institute	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PET Response Rate		FLT PET scan will be done 6-8 days after the dose of zoledronic acid	No