Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials
Text Size

Study of Radiation (RT) Concurrent With Cetuximab in Patients With Advanced Head and Neck Squamous Cell Carcinoma (SCC)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2015 by University of Michigan Cancer Center
Sponsor:
Information provided by (Responsible Party):
University of Michigan Cancer Center
ClinicalTrials.gov Identifier:
NCT00904345
First received: May 17, 2009
Last updated: January 6, 2015
Last verified: January 2015
History of Changes
  Purpose

This is a single-arm, phase II trial to characterize the clinical outcome of standard of care, cetuximab concurrent with radiation, in a special population (head and neck cancer patients who cannot tolerate concurrent chemoradiotherapy due to advanced age, poor performance status or concurrent illness), and to determine if biomarker response to a loading dose of cetuximab is predictive of that outcome.


Condition Intervention Phase
Head and Neck Cancer
 Drug: Cetuximab
Radiation: 50-60 Gy and 70 Gy
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of RT Concurrent w/ Cetuximab in Patients w/ Locally Advanced Head & Neck SCC Who Do Not Qualify For Standard Chemotherapy Due To Age >70 Or Co-Morbidities

Resource links provided by NLM:

Drug Information available for: Cetuximab
U.S. FDA Resources

Further study details as provided by University of Michigan Cancer Center:

Primary Outcome Measures:
  • Determine changes in tumor EGFR, pEGFR, following a loading dose of cetuximab in patients who are poor candidates for chemoradiation . [ Time Frame: 2 Years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Conduct normal mucosa EGFR assessment for comparison w/ tumor sample. [ Time Frame: 2 Years ] [ Designated as safety issue: No ]
  • Correlate HPV presence & titer w/ p53 status & clinical outcome. [ Time Frame: 2 Years ] [ Designated as safety issue: No ]
Estimated Enrollment: 50
Study Start Date: February 2009
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment Drug: Cetuximab
Patients will receive a single dose of cetuximab 400 mg/m (Day 0). On day 7 (+/- 1 day), a repeat biopsy will be performed. Radiation concurrent with weekly cetuximab 250 mg/m.
Radiation: 50-60 Gy and 70 Gy
Within approximately 4 days (after single dose of Cetuximab), definitive radiation will begin (70 Gy in 35 fractions to the gross tumor, 50-60 Gy to subclinical target volumes) concurrent with weekly cetuximab 250 mg/m.

Detailed Description:

Primary Objective 1: Determine changes in tumor EGFR, pEGFR, downstream signaling and novel phosphoproteins following a loading dose of cetuximab in patients who are poor candidates for chemoradiation (age =70 years or with significant co-morbidities) and are therefore treated with cetuximab with radiation.

Primary Objective 2: Characterize clinical outcomes, including local recurrence, progression-free survival and overall survival in these patients, and correlate these clinical outcomes with the changes in tumor EGFR, pEGFR, downstream signaling, and novel phosphoproteins.

Primary Objective 3: Describe the toxicity, in particular mucositis/dysphagia, of this regimen.

Secondary Objective 1: Conduct normal mucosa EGFR assessment for comparison with tumor sample.

Secondary Objective 2: Correlate HPV presence and titer with p53 status and clinical outcome.

  Eligibility
Ages Eligible for Study:   70 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must have pathologically-confirmed, previously untreated, clinically accessible (without general anesthesia) locally advanced squamous cell carcinoma of the larynx, hypopharynx, oropharynx, oral cavity, or nonresectable head and neck squamous cell carcinomas of the skin.

  • Patients will be limited to:

    • ≥ 70 years of age, OR
    • with co-morbidities that preclude treatment with standard platinum-based chemotherapy, as determined by the treating physician, OR
    • KPS ≤ 80, OR
    • Creatinine clearance < 30 cc/min

  • Laboratory criteria:

    • WBC > 3500/ul
    • Granulocyte > 1500/ul
    • Platelet count > 100,000/ul
    • Total Bilirubin < 1.5 X ULN
    • AST and ALT < 2.5 X ULN
  • Patients must give documented informed consent to participate in this study.

Exclusion Criteria:

  • Prior head and neck malignancy, or history of other prior non-head and neck malignancy within the past 3 years (excluding skin cancer and early stage treated prostate cancer).
  • Prior head and neck radiation or chemotherapy.
  • Documented evidence of distant metastases.
  • Patients with nasopharyngeal carcinoma.
  • Any medical or psychiatric illness, which, in the opinion of the principal investigator, would compromise the patient's ability to tolerate this treatment.
  • Patients with psychiatric/social situations that would limit compliance with study requirements are not eligible.
  • Patients with prior anti-epidermal growth-factor receptor antibody therapy (antibody or small molecule).
  • Patients residing in prison.
  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: NCT00904345

Contacts
Contact: Shruti Jolly,, M.D. 734-936-4302 shrutij@umich.edu

Locations
United States, Michigan
University of Michigan Medical Center Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Shruti Jolly, M.D.    734-936-4302    shrutij@umich.edu   
University of Michigan Veterans Administration Hospital Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Shruti Jolly, M.D.    734-936-4302    shrutij@umich.edu   
Principal Investigator: Shruti Jolly, M.D.         
Sponsors and Collaborators
University of Michigan Cancer Center
Investigators
Principal Investigator: Shruti Jolly, MD University of Michigan Cancer Center
  More Information

No publications provided

Responsible Party: University of Michigan Cancer Center
ClinicalTrials.gov Identifier: NCT00904345     History of Changes
Obsolete Identifiers: NCT01250522
Other Study ID Numbers: UMCC 2009.009, HUM 27253
Study First Received: May 17, 2009
Last Updated: January 6, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by University of Michigan Cancer Center:
SCC Head and Neck Cancer

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms
Neoplasms by Site
Cetuximab
 Antineoplastic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on March 03, 2015