Clinical trial NCT00904345: Study of Radiation (RT) Concurrent With Cetuximab in Patients With Advanced Head and Neck Squamous Cell Carcinoma (SCC)
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Head and Neck Cancer
Keywords: SCC Head and Neck Cancer
Lead sponsor: University of Michigan Rogel Cancer Center
Sponsor class: OTHER
First posted: 2009-05-19
Enrollment: 23
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

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 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.

Primary outcomes:
measure: Mean Change in Tumor Epidermal Growth Factor Receptor (EGFR)
timeFrame: At baseline (pre-loading dose) and day 7 post-loading dose
measure: Mean Change in Tumor Phosphorylated EGFR (pEGFR)
timeFrame: At baseline (pre-loading dose) and day 7 post-loading dose
measure: Progression Free Survival Rate
timeFrame: At 1 and 2 years
measure: Overall Survival Rate
timeFrame: At 1 and 2 Years
measure: Number of Participants With Treatment Related Toxicities
timeFrame: 3 years
Secondary outcomes:
measure: Change in Tumor EGFR Level Relative to EGFR in Normal Mucosa
timeFrame: At baseline (pre-loading dose) and day 7 post-loading dose
measure: Change in Tumor pEGFR Level Relative to pEGFR in Normal Mucosa
timeFrame: At baseline (pre-loading dose) and day 7 post-loading dose
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Medical Center
state: Michigan
city: Ann Arbor
country: United States
facility: University of Michigan Veterans Administration Hospital
state: Michigan
Study officials:
affiliation: University of Michigan Rogel Cancer Center
name: Shruti Jolly, MD
role: PRINCIPAL_INVESTIGATOR
References: