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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)


Phase 2
18 Years
N/A
Not Enrolling
Both
Lung Cancer, Metastatic Cancer

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Trial Information

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)


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

PET response rate

Outcome Time Frame:

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

Safety Issue:

No

Principal Investigator

Shirish M. Gadgeel, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Barbara Ann Karmanos Cancer Institute

Authority:

United States: Federal Government

Study ID:

CDR0000543463

NCT ID:

NCT00559897

Start Date:

March 2008

Completion Date:

April 2011

Related Keywords:

  • Lung Cancer
  • Metastatic Cancer
  • bone metastases
  • stage IIIB non-small cell lung cancer
  • stage IV non-small cell lung cancer
  • recurrent non-small cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms
  • Neoplasm Metastasis
  • Neoplasms
  • Neoplasms, Second Primary

Name

Location

Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201