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

Primary Purpose

Lung Cancer, Metastatic Cancer

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

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

Single photon emission computed tomography

About this trial

This is an interventional diagnostic trial for Lung Cancer focused on measuring bone metastases, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer, recurrent non-small cell lung cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Barbara Ann Karmanos Cancer Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

3'-deoxy-3'-[18F]FLT PET & zoledronic acid

Arm Description

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.

Outcomes

Primary Outcome Measures

PET Response Rate

Secondary Outcome Measures

Full Information

NCT ID

NCT00559897

First Posted

November 15, 2007

Last Updated

January 26, 2015

Sponsor

Barbara Ann Karmanos Cancer Institute

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT00559897

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

January 2015

Overall Recruitment Status

Terminated

Why Stopped

Slow accrual

Study Start Date

March 2008 (undefined)

Primary Completion Date

April 2010 (Actual)

Study Completion Date

April 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Barbara Ann Karmanos Cancer Institute

Collaborators

National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

6 (Actual)

8. Arms, Groups, and Interventions

Arm Title

3'-deoxy-3'-[18F]FLT PET & zoledronic acid

Arm Type

Experimental

Arm Description

Intervention Type

Other

Intervention Name(s)

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

Intervention Description

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.

Intervention Type

Procedure

Intervention Name(s)

Single photon emission computed tomography

Intervention Description

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.

Primary Outcome Measure Information:

Title

PET Response Rate

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Shirish M. Gadgeel, MD

Organizational Affiliation

Barbara Ann Karmanos Cancer Institute

Official's Role

Study Chair

Facility Information:

Facility Name

Barbara Ann Karmanos Cancer Institute

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48201-1379

Country

United States

12. IPD Sharing Statement

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

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