Chemotherapy Plus Radiation Therapy in Treating Patients With Squamous Cell Cancer of the Head and Neck

Phase 1

Completed

• Conditions: Head and Neck Cancer
• Interventions: Drug: Taxotere; Radiation: Radiation therapy

• Registration Number: NCT00003200
• Lead Sponsor: Dana-Farber Cancer Institute

Brief Summary

The purpose of this research study is to develop a new chemo radiotherapy regimen for the treatment of cancer of the head and neck for patients who have received induction chemotherapy; and to determine the highest dose of Taxotere which can be safely given together with radiotherapy.

Detailed Description

In this investigational research study investigators are attempting to develop a new chemo radiotherapy regimen in which radiotherapy and Taxotere will be combined after having received induction chemotherapy. Taxotere has never been given together with radiotherapy, the highest dose of Taxotere that can be safely used in this setting in unknown. Taxotere will be added to radiotherapy gradually as each subsequent group of 3-5 patients gets a larger dose. Taxotere doses will be increased until certain toxicities occur. This will help investigators determine the best way to combine Taxotere with radiotherapy and to use that knowledge to treat other patients with tumors like yours.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 1995-10
• Study First Submitted: 1999-11-01
• Study First Submitted QC: 2004-08-12
• Study First Posted: 2004-08-13
• Primary Completion: 2006-10
• Study Completion: 2008-06
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-17
• Last Update Posted: 2017-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Taxotere	Taxotere	After the screening procedures confirm participation in the research study: * Taxotere-Administered weekly for 1 hour (6 doses) * Radiation Therapy (XRT) -5 days a week for 6 weeks * Exam under anesthesia * Neck Dissection (if indicated)
Taxotere	Radiation therapy	After the screening procedures confirm participation in the research study: * Taxotere-Administered weekly for 1 hour (6 doses) * Radiation Therapy (XRT) -5 days a week for 6 weeks * Exam under anesthesia * Neck Dissection (if indicated)

Primary Outcome Measures

Name	Time	Method
MTD of weekly Taxotere	6 Weeks
Number of Participants of with Severe Adverse Events	6 Weeks

Trial Locations

Locations (4)

Dana-Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States

Harvard Community Health Plan; 🇺🇸 Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States