Zoledronic Acid and Positron Emission Tomography in Treating Patients With Advanced Non-Small Cell Lung Cancer
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Lung Cancer Metastatic Cancer |
Other: 3'-deoxy-3'-[18F]FLT Procedure: Single photon emission computed tomography |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: 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) |
- 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 ]
| Enrollment: | 5 |
| Study Start Date: | March 2008 |
| Study Completion Date: | April 2011 |
| Primary Completion Date: | April 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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| United States, Michigan | |
| Barbara Ann Karmanos Cancer Institute | |
| Detroit, Michigan, United States, 48201-1379 | |
| Study Chair: | Shirish M. Gadgeel, MD | Barbara Ann Karmanos Cancer Institute |
More Information
No publications provided
| Responsible Party: | Shirish Gadgeel, Principal Investigator, Barbara Ann Karmanos Cancer Institute |
| ClinicalTrials.gov Identifier: | NCT00559897 History of Changes |
| Other Study ID Numbers: | CDR0000543463, P30CA022453, WSU-2006-136 |
| Study First Received: | November 15, 2007 |
| Last Updated: | August 12, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by 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:
|
Carcinoma, Non-Small-Cell Lung Lung Neoplasms Neoplasm Metastasis Neoplasms Neoplasms, Second Primary Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site |
Lung Diseases Respiratory Tract Diseases Neoplastic Processes Pathologic Processes Zoledronic acid Diphosphonates Bone Density Conservation Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 22, 2013