Study of Radiation (RT) Concurrent With Cetuximab in Patients With Advanced Head and Neck Squamous Cell Carcinoma (SCC)
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
- 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 ]
- 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 2014 (Final data collection date for primary outcome measure) |
-
Drug: Cetuximab
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 |
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.
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| Contact: Cancer AnswerLine | 1-800-865-1125 |
| United States, Michigan | |
| University of Michigan Veterans Administration Hospital | Recruiting |
| Ann Arbor, Michigan, United States | |
| Contact: Shruti Jolly, M.D. 734-936-4302 shruti@umich.edu | |
| Principal Investigator: Shruti Jolly, M.D. | |
| University of Michigan Medical Center | Recruiting |
| Ann Arbor, Michigan, United States, 48109-0010 | |
| Contact: Shruti Jolly, M.D. 734-936-4302 shrutij@umich.edu | |
| 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 |
| Other Study ID Numbers: | UMCC 2009.009, HUM 27253 |
| Study First Received: | May 17, 2009 |
| Last Updated: | January 30, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Michigan Cancer Center:
|
SCC Head and Neck Cancer |
Additional relevant MeSH terms:
|
Carcinoma, Squamous Cell Head and Neck Neoplasms Carcinoma 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 May 23, 2013