NCT00757549

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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P75+ for early_phase_1 head-and-neck-cancer

Timeline
Completed

Started Sep 2008

Longer than P75 for early_phase_1 head-and-neck-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

September 22, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 23, 2008

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
6.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 25, 2017

Completed
Last Updated

October 31, 2017

Status Verified

March 1, 2017

Enrollment Period

2.9 years

First QC Date

September 22, 2008

Last Update Submit

October 27, 2017

Conditions

Head and Neck Cancer

Keywords

recurrent squamous cell carcinoma of the hypopharynxrecurrent squamous cell carcinoma of the larynxrecurrent squamous cell carcinoma of the oropharynxstage III squamous cell carcinoma of the hypopharynxstage III squamous cell carcinoma of the larynxstage III squamous cell carcinoma of the oropharynxstage IV squamous cell carcinoma of the hypopharynxstage IV squamous cell carcinoma of the larynxstage IV squamous cell carcinoma of the oropharynx

Outcome Measures

Primary Outcomes (1)

  • Percent change in the standard uptake value levels calculated for the identified volumes of interest for FLT and FDG PET scans from baseline to after 2 weeks of cetuximab therapy and from baseline to after 20-30 Gy of radiotherapy

Secondary Outcomes (1)

  • Quantified change values (after cetuximab therapy and after 20-30 Gy of radiotherapy) for the FLT and FDG PET scan-based topographic profiles created using the ImQuant software package

Interventions

cetuximabBIOLOGICAL
cisplatinDRUG
TdT-mediated dUTP nick end labeling assayGENETIC
3'-deoxy-3'-[18F]fluorothymidineOTHER
immunohistochemistry staining methodOTHER
laboratory biomarker analysisOTHER
fludeoxyglucose F 18RADIATION
radiation therapyRADIATION

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Head and Neck NeoplasmsSquamous Cell Carcinoma of Head and Neck

Interventions

CetuximabCisplatinalovudineImmunohistochemistryFluorodeoxyglucose F18Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsCarcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsHistocytochemistryCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisHistological TechniquesInvestigative TechniquesImmunologic TechniquesDeoxyglucoseDeoxy SugarsCarbohydratesTherapeutics

Study Officials

  • Jann N. Sarkaria, MD

    Mayo Clinic

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
early phase 1
Purpose
DIAGNOSTIC
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 22, 2008

First Posted

September 23, 2008

Study Start

September 1, 2008

Primary Completion

August 1, 2011

Study Completion

October 25, 2017

Last Updated

October 31, 2017

Record last verified: 2017-03

Locations

US(1)