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

Phase 2

Terminated

• Conditions: Metastatic Cancer; Lung Cancer
• Interventions: Other: 3'-deoxy-3'-[18F]FLT; Procedure: Single photon emission computed tomography

• Registration Number: NCT00559897
• Lead Sponsor: Barbara Ann Karmanos Cancer Institute

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.

Study Timeline

• Study First Submitted: 2007-11-15
• Study First Submitted QC: 2007-11-15
• Study First Posted: 2007-11-16
• Study Start: 2008-03
• Primary Completion: 2010-04
• Study Completion: 2011-04
• Status Verified: 2015-01
• Results First Submitted: 2015-01-26
• Results First Submitted QC: 2015-01-26
• Last Update Submitted: 2015-01-26
• Results First Posted: 2015-02-04
• Last Update Posted: 2015-02-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
3'-deoxy-3'-[18F]FLT PET & 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 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 PET & 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 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.

Primary Outcome Measures

Name	Time	Method
PET Response Rate	FLT PET scan will be done 6-8 days after the dose of zoledronic acid

Trial Locations

Locations (1)

Barbara Ann Karmanos Cancer Institute; 🇺🇸 Detroit, Michigan, United States