The goal of the study is to test a particular combination of drugs and determine their ability to completely eliminate head and neck cancer.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
44
Hydroxyurea at 1gm(PO)12hrs x 11days(2gm/day). The first daily dose of hydroxyurea on days 1-5 is given 2 hrs prior to the first fraction of daily radiotherapy.
Start continuous infusion of 5-Fluorouracil at 800mg/m2/day x 5 days (120 hrs. Radiation therapy is administered twice daily at 150 cGY per fraction, every other week with chemotherapy.
Cisplatin 100mg/m2 I.V. on the evening of the day 1, on cycles 1,3,and 5 only in 200cc NS IV over 2 h. Ensure adequate hydration to keep urine output \> 100 cc/ hour.
The University of Chicago
Chicago, Illinois, United States
Response Rates
To evaluate the activity of 5 cycles of C-FHX/G-CSF in previously untreated patients with stage II and IV locoregionally advanced head and neck cancer.
Time frame: 2-5 years
Feasibility of administering adjuvant CRA and interferon alfa2a
To determine the feasibility of administering adjuvant CRA and interferon alfa2a for up to one or until tumor progression in patients completing local therapy.
Time frame: 2-5 years
Side effects of study regimen
To determine the pattern and degree of clinical toxicity of this regimen
Time frame: 2-5 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.