Status:
COMPLETED
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
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Head and Neck Cancer
Eligibility:
All Genders
18-120 years
Phase:
EARLY_PHASE1
Brief 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 t...
Detailed Description
OBJECTIVES: Primary * To assess whether 3'-deoxy-3'-\[18F\] fluorothymidine (FLT) and fludeoxyglucose F 18 (FDG) PET scans can be used to identify patients with advanced squamous cell carcinoma of t...
Eligibility Criteria
Inclusion
- 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)
Exclusion
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 25 2017
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00757549
Start Date
September 1 2008
End Date
October 25 2017
Last Update
October 31 2017
Active Locations (1)
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1
Mayo Clinic
Rochester, Minnesota, United States, 55905