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

Barbara Ann Karmanos Cancer Institute

Status and phase: Terminated; Phase 2

Conditions: Metastatic Cancer; Lung Cancer

Treatments: Other: 3'-deoxy-3'-[18F]FLT; Procedure: Single photon emission computed tomography

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00559897

P30CA022453 (U.S. NIH Grant/Contract)

WSU-2006-136 (Other Identifier)

CDR0000543463

Details and patient eligibility

About

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.

Full 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.

Enrollment: 6 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

6 participants in 1 patient group

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

Experimental group

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.

Treatment:

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

Procedure: Single photon emission computed tomography