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Clinical Trial · NCT00757549
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
Overview
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.
Sponsor
Mayo Clinic
Phase
Early Phase 1
Contacts
Jann N. Sarkaria, MD (STUDY_CHAIR)
ClinicalTrials.gov
NCT00757549Drug / Compound
Fluorothymidine
Isotope(s):
FLUORINE-18
Radioisotope: F-18
Theranostic Role: PET Imaging
T1/2 (Half-Life): 1.8 Hours
Decay Mode: POSITRON β+ (96.7%), ELECTRON CAPTURE (3.3%), GAMMA 511 keV
Energy: Eβ+ 635 keV
Range: N/A
Decay Daughters: O18 (Stable)
Status: FDA Approvals: FDG (Cancer 2005): GLUDEF®, METATRACE® AXUMIN® (2016), PYLARIFY® (2023), POSLUMA® (2024)
Target(s):
- cytosolic thymidine kinase 1
Ligand Class: Small Molecules
Fludeoxyglucose
Isotope(s):
FLUORINE-18
Radioisotope: F-18
Theranostic Role: PET Imaging
T1/2 (Half-Life): 1.8 Hours
Decay Mode: POSITRON β+ (96.7%), ELECTRON CAPTURE (3.3%), GAMMA 511 keV
Energy: Eβ+ 635 keV
Range: N/A
Decay Daughters: O18 (Stable)
Status: FDA Approvals: FDG (Cancer 2005): GLUDEF®, METATRACE® AXUMIN® (2016), PYLARIFY® (2023), POSLUMA® (2024)
Target(s):
- Glucose Transport
Ligand Class: Small Molecules
Eligibility
Inclusion
- Requires chemoradiotherapy
- Weight loss ≤ 10% within the past 3 months
- Histologically or cytologically confirmed squamous cell carcinoma of the oropharynx, larynx, or hypopharynx
- ECOG performance status 0-1
- Creatinine clearance ≥ 40 mL/min
- Fertile patients must use effective contraception
- Negative pregnancy test
- AST ≤ 3 times ULN
- Hemoglobin ≥ 8 g/dL
- Life expectancy ≥ 16 weeks
- Platelet count ≥ 100,000/mm³
- ANC ≥ 1,500/mm³
- Advanced disease
- Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
- More than 2 weeks since prior major surgery and recovered
Exclusion
- No peripheral neuropathy ≥ grade 2
- No uncontrolled infection
- No poorly controlled diabetes that would limit the ability to obtain reliable fludeoxyglucose F 18 PET scan results
- No NYHA class III-IV heart disease
- Not pregnant or nursing
- No other severe underlying disease that, in the judgment of the investigator, would preclude study participation
- No prior radiotherapy to the planned treatment field
- No concurrent prophylactic filgrastim (G-CSF) or sargramostim (GM-CSF)
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