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Completed

Early Phase 1
Age: 18Years - 120Years
All Genders
ID00757549

Comparison of FLT and FDG PET in the Evaluation of Response to Cetuximab, Cisplatin and Radiation Therapy in Advanced Head and Neck Malignancies or Response to Standard Chemo-radiotherapy in Esophageal Malignancies

Led by Mayo Clinic · Updated on 2017-10-31

30

Participants Needed

1

Research Sites

325 weeks

Total Duration

On this page

Sponsors

M

Mayo Clinic

Lead Sponsor

N

National Cancer Institute (NCI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

RATIONALE: Diagnostic procedures, such as 3'-deoxy-3'-\[18F\] fluorothymidine (FLT) and fludeoxyglucose F 18 (FDG) PET scans, may help doctors predict a patient's response to treatment and help plan the best treatment. PURPOSE: This pilot trial is studying FLT and FDG PET scans to see how well they evaluate response to cetuximab, cisplatin, and radiation therapy in patients with advanced cancer of the oropharynx, larynx, or hypopharynx.

CONDITIONS

Brief Title

3'-Deoxy-3'-[18F] Fluorothymidine and Fludeoxyglucose F 18 PET Scans in Evaluating Response to Cetuximab, Cisplatin, and Radiation Therapy in Patients With Advanced Cancer of the Oropharynx, Larynx, or Hypopharynx

Who Can Participate

Age: 18Years - 120Years
All Genders

Eligibility Criteria

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed squamous cell carcinoma of the oropharynx, larynx, or hypopharynx

    • Advanced disease
  • Requires chemoradiotherapy

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-1
  • Life expectancy ≥ 16 weeks
  • Weight loss ≤ 10% within the past 3 months
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • ANC ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • AST ≤ 3 times ULN
  • Hemoglobin ≥ 8 g/dL
  • Creatinine clearance ≥ 40 mL/min
  • No peripheral neuropathy ≥ grade 2
  • No NYHA class III-IV heart disease
  • No uncontrolled infection
  • No poorly controlled diabetes that would limit the ability to obtain reliable fludeoxyglucose F 18 PET scan results
  • No other severe underlying disease that, in the judgment of the investigator, would preclude study participation

PRIOR CONCURRENT THERAPY:

  • More than 2 weeks since prior major surgery and recovered
  • No prior radiotherapy to the planned treatment field
  • No concurrent prophylactic filgrastim (G-CSF) or sargramostim (GM-CSF)

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