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Sponsors and Collaborators: |
University of Kentucky Eli Lilly and Company |
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Information provided by: | University of Kentucky |
ClinicalTrials.gov Identifier: | NCT00176241 |
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.
Condition | Intervention | Phase |
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Head and Neck Cancer |
Drug: gemcitabine Drug: paclitaxel Radiation: radiation |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase I Trial of Biweekly Gemcitabine & Paclitaxel & Low-Dose Fractionated Radiation in the Treatment of Metastatic or Recurrent Head & Neck Cancer |
Estimated Enrollment: | 21 |
Study Start Date: | December 2005 |
Estimated Study Completion Date: | November 2009 |
Estimated Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
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
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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:
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Valorie Gray, CCRC | 859-323-0250 | valgray@email.uky.edu |
Contact: Susanne Arnold, MD | 859-323-8043 | smarno0@email.uky.edu |
United States, Kentucky | |
University of Kentucky | Recruiting |
Lexington, Kentucky, United States, 40536 | |
Contact: Valorie Gray 859-323-0250 valgray@email.uky.edu | |
Principal Investigator: Susanne Arnold, MD |
Principal Investigator: | Susanne Arnold, MD | University of Kentucky |
Responsible Party: | University of Kentucky ( Susanne Arnold, MD, Associate Professor of Medicine ) |
Study ID Numbers: | 04-H&N-16-EL |
Study First Received: | September 12, 2005 |
Last Updated: | June 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00176241 |
Health Authority: | United States: Institutional Review Board |
head and neck Gemcitabine Paclitaxel radiation |
low-dose radiation recurrent metastatic |
Paclitaxel Head and Neck Neoplasms Gemcitabine Recurrence |
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Mitosis Modulators Physiological Effects of Drugs Enzyme Inhibitors Antimitotic Agents |
Antiviral Agents Immunosuppressive Agents Pharmacologic Actions Neoplasms Neoplasms by Site Radiation-Sensitizing Agents Therapeutic Uses Tubulin Modulators Antineoplastic Agents, Phytogenic |