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Terminated Phase 1 Interventional

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

ClinicalTrials.gov ID: NCT00176241

Public ClinicalTrials.gov record NCT00176241. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 23, 2026, 7:41 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT00176241
Recruitment status
Terminated
Study type
Interventional
Phase
Phase 1
Lead sponsor
Susanne Arnold
Other
Enrollment
7 participants

Conditions and interventions

Interventions

Drug · Radiation

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Nov 30, 2005
Primary completion
Aug 31, 2008
Completion
Oct 31, 2008
Last update posted
Jun 7, 2015

2005 – 2008

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
University of Kentucky Lexington Kentucky 40536

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00176241, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jun 7, 2015 · Synced Sep 23, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00176241 live on ClinicalTrials.gov.

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