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

• Status: Completed
• Trial end date: 2017-10-25
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mayo Clinic
• Collaborator: National Cancer Institute (NCI)
• Treatments: Alovudine; Cetuximab; Cisplatin; Dideoxynucleosides; Fluorodeoxyglucose F18

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)