Determine Tumor Response Using Fluorodeoxyglucose (FDG)- Positron Emission Tomography (PET)/Computed Tomography (CT) Before and After Cetuximab in Patients With Head and Neck Cancer (SCCHN)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00671437
First received: May 1, 2008
Last updated: June 11, 2013
Last verified: June 2013
  Purpose

The purpose of this study is to collect data and evaluate how the tumor is broken down in response to standard of care cetuximab treatment by evaluating the FDG-PET/CT scans, toxicity, see how well the FDG-PET/CT scans predict response to treatment and survival.


Condition Intervention Phase
Carcinoma, Squamous Cell
Procedure: FDG-PET/CT
Drug: Cetuximab
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Determination of Tumor SUV by FDG-PET/CT Before and After Cetuximab in Patients With Metastatic Squamous Cell Carcinoma of the Head and Neck

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • 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. [ Time Frame: Baseline and after 8 weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine the overall tumor metabolic response to eight weeks of scheduled weekly doses of cetuximab as assessed by FDG-PET/CT performed at baseline and then after therapy [ Time Frame: After 8 weeks of treatment ] [ Designated as safety issue: No ]
  • To correlate the overall tumor metabolic response as assessed by FDG-PET/CT with the anatomic tumor response rate by RECIST criteria as assessed by CT and clinical examination [ Time Frame: After 8 weeks of treatment ] [ Designated as safety issue: No ]
  • Correlate the overall tumor metabolic response and overall anatomic tumor response and clinical examination obtained at baseline and after eight weeks of treatment with cetuximab to time to progression and overall survival with cetuximab therapy [ Time Frame: Every 8 weeks until disease progression ] [ Designated as safety issue: No ]
  • Determine the overall best anatomic tumor response rate to cetuximab given until disease progression as assessed by RECIST criteria using CT & clinical examination [ Time Frame: Every 8 weeks until disease progression ] [ Designated as safety issue: No ]
  • Determine the overall disease control rate by RECIST criteria as assessed by CT and clinical examination and to determine the TTP and the OS with cetuximab therapy [ Time Frame: Every 8 weeks until disease progression ] [ Designated as safety issue: No ]
  • Assess the toxicity profile for standard of care cetuximab given to patients with metastatic squamous cell carcinoma of the head and neck [ Time Frame: 30 days after end of study treatment ] [ Designated as safety issue: Yes ]

Enrollment: 42
Study Start Date: June 2008
Estimated Study Completion Date: May 2014
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1

Cetuximab 400 mg/m2 IV over 2 hours on day 1 and 250 mg/m2 IV over 1 hour on days 8, 15, 22, 29, 36, 43, and 150.

On Day 57, CT scan of neck and check and whole body FDG-PET/CT will be performed before patient receives cetuximab 250 mg/m2 IV>

Procedure: FDG-PET/CT Drug: Cetuximab
Other Name: Erbitux

Detailed Description:

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00671437

Locations
United States, Kentucky
University of Louisville
Louisville, Kentucky, United States
United States, Missouri
Washington University
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Douglas Adkins, M.D. Washington Univerisity
  More Information

Additional Information:
Publications:
J. Trigo et al., Cetuximab monotherapy is active in patients with platinum-refractory recurrent/metastatic squamous cell carcinoma of the head and neck: Results of a phase II study (abstract). Proc Am Soc Clin Oncol 23 (2004), p. 487a.
M. Beeram et al., Durable disease stabilization and antitumor activity with OSI-774 in renal cell carcinoma: A phase II, pharmacokinetic (PK) and biological correlative study with FDG-PET imaging. J Clinical Oncology 22 (2004), pp. 3050.
T. Trarbach et al., A randomized phase I study of the humanized anti-epidermal growth factor receptor (EGFR) monoclonal antibody EMD 72000 in subjects with advanced gastrointestinal cancers. J Clinical Oncology 22 (2004), pp. 3018.

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00671437     History of Changes
Other Study ID Numbers: 08-0285 / 201107108
Study First Received: May 1, 2008
Last Updated: June 11, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Washington University School of Medicine:
squamous cell carcinoma of the head and neck

Additional relevant MeSH terms:
Carcinoma, Squamous Cell
Carcinoma
Head and Neck Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Neoplasms by Site
Cetuximab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 01, 2014