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

Head and Neck Cancer Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00176241
Study type Interventional
Source University of Kentucky
Contact
Status Terminated
Phase Phase 1
Start date December 2005
Completion date November 2008
View Details
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