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Protocol No. NRGHN001

Principal Investigator Harari, Paul

Phase II/III

Age Group Adult

Scope National

Sponsor Type National

Title Randomized Phase II and Phase III Studies of Individualized Treatment for Nasopharyngeal Carcinoma based on Biomarker Epstein Barr Virus (EBV) Deoxyribonucleic acid (DNA)

Objective 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.

Treatment
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

  • Description Randomized Phase II and Phase III study

    Key Eligibility
  • 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

    Status Open

    Participating Institutions UW Hospital and Clinics