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

NCT00559897 | Terminated Phase 2 Results DMC

• 3 other identifiers: CDR0000543463P30CA022453WSU-2006-136
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• PET Response Rate

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

Study Arms (1)

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

EXPERIMENTAL

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; Procedure: Single photon emission computed tomography

Interventions

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

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.

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

Single photon emission computed tomography PROCEDURE

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.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Barbara Ann Karmanos Cancer Institute: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201-1379, United States

Location

MeSH Terms

Conditions

Lung Neoplasms; Neoplasm Metastasis; Carcinoma, Non-Small-Cell Lung

Interventions

alovudine

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Carcinoma, Bronchogenic; Bronchial Neoplasms

Limitations and Caveats

None of the participants were evaluable.

Results Point of Contact

• Title: Dr. Shirish Gadgeel
• Organization: Barbara Ann Karmanos Cancer Institute

gadgeels@karmanos.org

313-576-8753

Study Officials

• Shirish M. Gadgeel, MD

  Barbara Ann Karmanos Cancer Institute

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 15, 2007
• First Posted: November 16, 2007
• Study Start: March 1, 2008
• Primary Completion: April 1, 2010
• Study Completion: April 1, 2011
• Last Updated: February 4, 2015
• Results First Posted: February 4, 2015

Record last verified: 2015-01

Locations

US (1)