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Randomized Phase II and Phase III Studies of Individualized Treatment for Nasopharyngeal Carcinoma based on Biomarker Epstein Barr Virus (EBV) Deoxyribonucleic acid (DNA)
This study is being done to see how people with your type of cancer respond to different types or levels of chemotherapy, based on a specific viral marker in their blood. This viral marker is called the Epstein Barr virus, (EBV). A more individualized approach to treating your type of cancer might be found using this blood marker.
This study has four study groups
For patients with any level of EBV DNA in their blood after radiation and chemotherapy:
Group 1 will get the usual chemotherapy drugs used for this type of cancer (cisplatin and 5-fluorouracil) every 4 weeks for 12 weeks.
Group 2 will get the chemotherapy drugs gemcitabine and paclitaxel every 3 weeks for 12 weeks.
For patients with no amount of EBV DNA in their blood after radiation and chemotherapy:
Group 3 will get the usual chemotherapy drugs used for this type of cancer (cisplatin and 5-fluorouracil) every 4 weeks for 12 weeks.
Group 4 will be observed but will not get chemotherapy
Randomized Phase II and Phase III study
Biopsy proven (from primary lesion and/or lymph nodes) diagnosis of cancer of the nasopharynx
Stage II-IVB disease with no evidence of distant metastasis
Zubrod Performance Status 0-1
Exclusion: No Prior invasive malignancy unless disease free for a minimum of 3 years
Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable
No prior radiation to the region of study cancer
No sensorineural hearing loss
No ≥ grade 2 peripheral sensory neuropathy
No MI within the last 6 months, unstable angina,uncontrolled CHF; COPD requiring hospitalization within 30 days
No Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception
Applicable Disease Sites
Head and Neck
UW Hospital and Clinics