NRG HN001

Official Title

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

Study Purpose

To compare the standard treatment for nasopharyngeal cancer with the drug combination gemcitabine and paclitaxel.  This is also testing if directing treatment using a blood test to look for the Epstien Bar Virus will result in patients doing better and not needing as much treatment.

Diagnosis

Eligibility

Must have detectable Epstein Barr Virus in their blood before starting the standard chemotherapy with radiation treatment.

No significant hearing lose that requires a hearing aid or other treatment to aid in hearing.

No significant problems with neuropathy (loss of feeling in hands and/or feet).

No evidence of distant metastatic cancer.

No Prior therapy.

Patients must sign an approved informed consent and authorization permitting release of personal health information.

Intervention

• Chemotherapy: Cisplatin, Fluorouracil, Gemcitabine, Paclitaxel

All patients will initially be treated with the standard of care chemotherapy and radiation therapy at the same time.  After that is complete patients will have a blood drawn and be assigned to the treatment groups based on the presence of the Epstein Barr Virus in their blood.             

For patients who have the Epstein Barr Virus in their blood

• Arm 1: Cisplatin and Fluorouracil every 28 days for 3 cycles
• Arm 2: Gemcitabine and Paclitaxel on day 1 and day 8 of each 21 day cycle for 4 cycles.

For patients who do not have the Epstein Barr Virus in their blood

• Arm 3: Cisplatin and Fluorouracil every 28 days for 3 cycles
• Arm 4: Observation