A Multicenter Study of Intensive Concomitant Chemoradiotherapy With Filgrastim (GCSF) for Patients With Locoregionally Advanced Head and Neck Cancer

PHASE2CompletedINTERVENTIONAL
Enrollment

44

Participants

Timeline

Start Date

March 31, 2003

Primary Completion Date

September 30, 2003

Study Completion Date

September 30, 2004

Conditions
Head and Neck
Interventions
DRUG

Hydroxyurea

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.

DRUG

5- Fluorouracil

"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."

DRUG

Cisplatin

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.

Trial Locations (1)

60653

The University of Chicago, Chicago

All Listed Sponsors
lead

University of Chicago

OTHER

NCT01693718 - A Multicenter Study of Intensive Concomitant Chemoradiotherapy With Filgrastim (GCSF) for Patients With Locoregionally Advanced Head and Neck Cancer | Biotech Hunter | Biotech Hunter