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

NCT00176241 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2015-06-08

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Susanne Arnold, MD · University of Kentucky

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-12-31
Primary Completion
2008-09-30
Completion
2008-11-30

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00176241 on ClinicalTrials.gov