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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


Phase 2
70 Years
N/A
Open (Enrolling)
Both
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

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Tumor Response to Concurrent Cetuximab and Radiation Therapy

Outcome Description:

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.

Outcome Time Frame:

6 months

Safety Issue:

No

Principal Investigator

Shruti Jolly, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Michigan Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

2009.009

NCT ID:

NCT01250522

Start Date:

April 2009

Completion Date:

December 2019

Related Keywords:

  • 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
  • Oral cancer
  • over age 70
  • chemotherapy restricted
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Laryngeal Neoplasms
  • Head and Neck Neoplasms

Name

Location
The University of Michigan Comprehensive Cancer Center Ann Arbor, Michigan  48109