Status:
COMPLETED
Erlotinib, Celecoxib and Reirradiation for Recurrent Head and Neck Cancer
Lead Sponsor:
Johnny Kao
Conditions:
Cancer of the Pharynx
Cancer of the Larynx
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
There is no optimal treatment for patients with recurrent head and neck cancer after previous radiation. Chemotherapy alone is not curative and patients survive an average of only 6 to 10 months. Surg...
Detailed Description
Despite advances in the treatment of head and neck cancer, locoregional recurrences are the predominant site of treatment failure and are frequently the cause of death. Second primary tumors in the he...
Eligibility Criteria
Inclusion
- Age 18 years or older
- Histologically or cytologically confirmed diagnosis of squamous cell or poorly differentiated carcinomas of the head and neck or lymphoepithelioma
- Prior radiation to the head and neck, surgery or chemotherapy is allowed
- Karnofsky performance status of \>= 70%
- Intact organ and bone marrow function
- Obtained informed consent
Exclusion
- Demonstration of metastatic disease (i.e. M1 disease).
- Incomplete healing from previous surgery
- Pregnancy or breast feeding (men and women of child-bearing potential are eligible but must consent to using effective contraception during therapy and for at least 3 months after completing therapy)
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure (CHF), unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Patients with clinically significant pulmonary dysfunction, cardiomyopathy, or any history of clinically significant CHF are excluded. The exclusion of patients with active coronary artery disease will be at the discretion of the attending physician.
- Uncontrolled active infection unless curable with treatment of their cancer.
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00970502
Start Date
February 1 2007
End Date
November 1 2010
Last Update
April 10 2017
Active Locations (1)
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1
Mount Sinai School of Medicine
New York, New York, United States, 10029