Phase I Trial of Biweekly Gemcitabine & Paclitaxel & Low-Dose Radiation for Metastatic or Recurrent Head & Neck Cancer
Status:
Terminated
Trial end date:
2008-11-01
Target enrollment:
Participant gender:
Summary
This study seeks to establish the safety of gemcitabine, paclitaxel and low-dose radiation in
recurrent, metastatic head and neck cancer through a two-stage dose escalation study, first
with Gemcitabine dose escalation and then with low-dose radiation escalation.
Treatment Schedule
Treatment will be administered on an inpatient or outpatient basis.
- Gemcitabine:2000 to 3000mg/m2 IV (in the vein) on days 1 and 15 every 28 days over 30-60
minutes.
- Paclitaxel: 150 mg/m2 IV(in the vein)on days 1 and 15 every 28 days over 60 minutes.
- Low Dose Radiation: 50-80 cGy twice daily on days 1, 2, 15, & 16 every 28 days at least
4 hours apart.