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Radiation With Cetuximab in Head and Neck Squamous Cell Carcinoma Who Do Not Qualify For Chemotherapy

This study is currently recruiting participants.
Verified February 2013 by University of Michigan Cancer Center
Sponsor:
Information provided by (Responsible Party):
University of Michigan Cancer Center
ClinicalTrials.gov Identifier:
NCT01250522
First received: September 24, 2010
Last updated: February 12, 2013
Last verified: February 2013
History of Changes
  Purpose

The PI proposes to select locally advanced head and neck cancer patients, who are older than age 70 or are not deemed candidates for chemotherapy, to determine changes in tumor Epidermal Growth Factor Receptor (EGFR), Phosphorylated Epidermal Growth Factor Receptor (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 and radiation.

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. Describe the toxicity, in particular mucositis/dysphagia, of this regimen.


Condition Intervention Phase
Squamous Cell Carcinoma of the Larynx, Hypopharynx, Oropharynx, or Oral Cavity.
The Patients Will be Limited to Age 70 and Older,
OR w/ Co-morbidities Precluding Treatment With Chemotherapy
 Procedure: Biopsy
Procedure: 2 oral mucosa samples will be taken a week apart
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Radiation Therapy Concurrent With Cetuximab in Patients With Locally Advanced Head and Neck Squamous Cell Carcinoma Who Do Not Qualify For Standard Chemotherapy Due To Age>70 Or Co-Morbidities

Resource links provided by NLM:

MedlinePlus related topics: Cancer
Drug Information available for: Cetuximab
U.S. FDA Resources

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

Primary Outcome Measures:
  • Tumor Response to Concurrent Cetuximab and Radiation Therapy [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Determine changes in tumor Epidermal Growth Factor Receptor (EGFR), Phosphorylated Epidermal Growth Factor Receptor (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 and radiation.

  • Evaluate Effectiveness and Toxicity of Concurrent Cetuximab and Radiation Therapy [ Time Frame: 6 months ] [ Designated as safety issue: No ]

    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.

    Describe the toxicity, in particular mucositis/dysphagia, of this regimen.



Secondary Outcome Measures:
  • Compare Mucosa with Tumor [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Conduct normal mucosa EGFR assessment for comparison with tumor sample.


Estimated Enrollment: 50
Study Start Date: April 2009
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment Procedure: Biopsy
2 Research Biopsies a week apart - of the oral cancer area
Other Name: Biopsy
Procedure: 2 oral mucosa samples will be taken a week apart
Oral Mucosa Sampling
Other Name: buccal swab

  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, or oral cavity. The patients will be limited to age 70 and older, OR with co-morbidities that preclude treatment with standard platinum-based chemotherapy, as determined by the treating physician, OR KPS of at least 80, OR Creatinine clearance less than 30cc/min.

Exclusion Criteria:

  • younger than age 70
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01250522

Contacts
Contact: Cancer AnswerLine 1-800-865-1125

Locations
United States, Michigan
The University of Michigan Comprehensive Cancer Center Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Cancer Answerline     800-865-1125        
Principal Investigator: Shruti Jolly, MD            
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: NCT01250522     History of Changes
Other Study ID Numbers: 2009.009, HUM 27253
Study First Received: September 24, 2010
Last Updated: February 12, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Michigan Cancer Center:
Oral cancer
over age 70
chemotherapy restricted

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

ClinicalTrials.gov processed this record on June 18, 2013