Ignite Creation Date:
2024-05-05 @ 11:55 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00176241
Status:
TERMINATED
Last Update Posted:
2015-06-08
First Post:
2005-09-12
Brief Title:
Phase I Trial of Biweekly Gemcitabine Paclitaxel Low-Dose Radiation for Metastatic or Recurrent Head Neck Cancer
Sponsor:
Susanne Arnold
Organization:
University of Kentucky
Study Overview
Official Title:
A Phase I Trial of Biweekly Gemcitabine Paclitaxel Low-Dose Fractionated Radiation in the Treatment of Metastatic or Recurrent Head Neck Cancer
Status:
TERMINATED
Status Verified Date:
2015-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Slow accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Gemcitabine2000 to 3000mgm2 IV in the vein on days 1 and 15 every 28 days over 30-60 minutes
Paclitaxel 150 mgm2 IVin the veinon 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
Treatment Schedule
Treatment will be administered on an inpatient or outpatient basis
Gemcitabine2000 to 3000mgm2 IV in the vein on days 1 and 15 every 28 days over 30-60 minutes
Paclitaxel 150 mgm2 IVin the veinon 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 p21waf1cip1 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
Gemcitabine2000 to 3000mgm2 IV on days 1 and 15 every 28 days over 30-60 minutes
Paclitaxel 150 mgm2 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
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 p21waf1cip1 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
Gemcitabine2000 to 3000mgm2 IV on days 1 and 15 every 28 days over 30-60 minutes
Paclitaxel 150 mgm2 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None