NCT00176241

Phase I Trial of Biweekly Gemcitabine & Paclitaxel & Low-Dose Radiation for Metastatic or Recurrent Head & Neck Cancer

A Phase I Trial of Biweekly Gemcitabine & Paclitaxel & Low-Dose Fractionated Radiation in the Treatment of Metastatic or Recurrent Head & Neck Cancer

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Susanne Arnold · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Objectives: 1\. To assess the MTD of low-dose fractionated radiation in combination with Gemcitabine and Paclitaxel in recurrent or metastatic head and neck cancer in the relapsed setting. Secondary Objectives: 1. To assess quantitative toxicities in this group of patients treated with this regimen. 2. To assess response rate in this group of patients treated with this regimen 3. To investigate in an exploratory manner, the association of tumor markers p53, p21waf1/cip1, bcl-xL, bcl-2 and bax (evaluated by immunohistochemistry) with response rate using pre- and post-treatment biopsies. 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 on days 1 and 15 every 28 days over 30-60 minutes. * Paclitaxel: 150 mg/m2 IV 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.

Conditions

• Head and Neck Cancer

Interventions

Type	Name	Description
DRUG	gemcitabine	2000-3000mg/m2 IV on days 1 \& 15
DRUG	paclitaxel	150 mg/m2 IV on days 1 \& 15
RADIATION	radiation	50-80 cGy on days 1,2,15,16

Timeline

• Start date: 2005-12-01
• Primary completion: 2008-09-01
• Completion: 2008-11-01
• First posted: 2005-09-15
• Last updated: 2015-06-08

Locations

1 site across 1 country: United States