Status:
WITHDRAWN
Study Using Pharmacogenetics to Select Treatment for Head and Neck Cancer
Lead Sponsor:
Georgetown University
Conditions:
Head and Neck Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is a study for patients with head and neck cancer who will be receiving chemotherapy and radiation therapy for their disease. The purpose of this study is to see if the investigators can use gene...
Detailed Description
Treatment-naive patients with locally advanced, non-metastatic (Stage III to IVB) squamous cell carcinoma of the head and neck who are candidates for concurrent chemoradiotherapy as primary therapy wi...
Eligibility Criteria
Inclusion
- Biopsy proven squamous cell carcinoma of the head and neck, including of the oral cavity, oropharynx, hypopharynx, or larynx
- Locally advanced, Stage III or IVB disease and a candidate for primary therapy using chemotherapy and radiation with curative intent
- Patients with a diagnosis of 'unknown primary' will be eligible if chemoradiotherapy is primary modality of treatment
- No previous chemotherapy, radiation, or surgery for the diagnosis of head and neck cancer
- ECOG performance status 0 or 1
- Negative pregnancy test
- Hemoglobin \>/= 8.0
- Absolute neutrophil count \>/= 1500
- Platelet count \>/= 100,000
- GFR \> 50 mL/min
- Total bilirubin \</= 1.5 upper limits of normal
- AST and ALT \</= 2.5 times upper limits of normal
- No other current malignancy, other than basal cell skin cancer, squamous cell skin cancer, in situ cervical cancer, ductal or lobular in situ of the breast.
- Ability and willingness to give consent
- Subjects must in the opinion of the Investigator be capable of complying with the protocol
Exclusion
- Primary tumors of the nasopharynx, sinuses, and salivary glands
- Acute treatment for an infection or other serious medical illness within 14 days prior to study entry
- Major surgery within 3 weeks prior to study entry
- Known hypersensitivity to cisplatin or cetuximab
- Patients who have any severe or uncontrolled medical conditions or other conditions that could affect their participation in this study including: unstable angina, serious uncontrolled cardiac arrhythmia, active or uncontrolled infectious disorder, myocardial infarction \</= 6 months prior to study entry
- Psychiatric illness that would limit compliance with study requirements
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00881114
Start Date
April 1 2009
End Date
June 1 2013
Last Update
March 27 2015
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