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Determination of Tumor SUV by FDG-PET/CT Before and After Cetuximab in Patients With Metastatic Squamous Cell Carcinoma of the Head and Neck


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Carcinoma, Squamous Cell

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Trial Information

Determination of Tumor SUV by FDG-PET/CT Before and After Cetuximab in Patients With Metastatic Squamous Cell Carcinoma of the Head and Neck


Primary Endpoint

To compare the SUV at up to three target tumor sites as assessed by FDG-PET/CT of eligible
patients at baseline and then after eight weeks of treatment with cetuximab.

Secondary Endpoints

- To determine the overall tumor metabolic response (complete metabolic response, partial
metabolic response, stable metabolic disease or progressive metabolic disease [CMR,
PMR, SMD, or PMD]) to eight weeks of scheduled weekly doses of cetuximab as assessed by
FDG-PET/CT performed at baseline and then after therapy.

- To correlate the overall tumor metabolic response (CMR, PMR, SMD, or PMD) as assessed
by FDG-PET/CT with the anatomic tumor response rate (complete response, partial
response, stable disease or progressive disease [CR, PR, SD, or PD]) by RECIST criteria
as assessed by CT and clinical examination performed after eight weeks of scheduled
weekly doses of cetuximab.

- To correlate the overall tumor metabolic response (CMR, PMR, SMD, or PMD) as assessed
by FDG-PET/CT and to correlate the overall anatomic tumor response (CR, PR, SD, or PD)
by RECIST criteria as assessed by CT and clinical examination obtained at baseline and
after eight weeks of treatment with weekly scheduled doses of cetuximab to TTP and OS
with cetuximab therapy.

- To determine the overall best anatomic tumor response rate (CR, PR, SD, or PD) to
cetuximab given until disease progression as assessed by RECIST criteria using CT and
clinical examination.

- To determine the overall disease control rate (CR, PR, and SD) by RECIST criteria as
assessed by CT and clinical examination and to determine the TTP and the OS with
cetuximab therapy.

- To assess the toxicity profile for standard of care cetuximab given to patients with
metastatic squamous cell carcinoma of the head and neck.


Inclusion Criteria:



- Histologically proven diagnosis of squamous cell carcinoma of the head and neck
(SCCHN).

- Have either locally recurrent, unresectable, previously irradiated SCCHN OR
metastatic SCCHN, with at least one measurable tumor lesion (by CT scan) and at least
one FDG avid (SUV >/= 3, >/= 1.5 cm) tumor lesion (by PET/CT).

- Age greater than 18 yrs.

- ECOG Performance Status of 0-3

- Signed IRB approved Informed Consent.

Exclusion Criteria:

- Clinical history of severe interstitial lung disease (not COPD)-as defined by prior
PFT's with residual volume, total lung capacity, or corrected DLCO <30% of predicted.
For this study, screening PFT's required only if clinically indicated.

- Prior therapy with an EGFR-specific monoclonal antibody (MAB) for treatment of
metastatic SCCHN. Prior therapy with an EGFR-specific MAB as part of the definitive
treatment of non-metastatic SCCHN is acceptable if this occurred more than three
months previously. Prior therapy with an EGFR specific TKI will not be an exclusion
factor.

- Women of child bearing potential who are current pregnant or breast feeding.

- Prior severe (Grade 4) infusion reaction to cetuximab.

- A serious uncontrolled medical disorder that in the opinion of the Investigator would
impair the ability of the subject to receive protocol therapy.

- Chemotherapy, radiation therapy, or investigational agents given with the last 14
days.

- Uncontrolled diabetes mellitus. (Subjects with a fasting blood glucose > 200 at time
of PET scanning may need to reschedule to another day after consulting with
appropriate physicians.)

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To compare the SUV at up to three target tumor sites as assessed by FDG-PET/CT of eligible patients at baseline and then after eight weeks of treatment with cetuximab.

Outcome Time Frame:

Baseline and after 8 weeks of treatment

Safety Issue:

No

Principal Investigator

Douglas Adkins, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Washington Univerisity

Authority:

United States: Institutional Review Board

Study ID:

08-0285 / 201107108

NCT ID:

NCT00671437

Start Date:

June 2008

Completion Date:

May 2014

Related Keywords:

  • Carcinoma, Squamous Cell
  • squamous cell carcinoma of the head and neck
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms

Name

Location

University of LouisvilleLouisville, Kentucky  40202
Washington UniversitySt. Louis, Missouri  63110