Chemotherapy Plus Gefitinib Followed by Chemotherapy, Radiation Therapy, and Gefitinib For Head and Neck Cancer

Phase 2

Completed

• Conditions: Head and Neck Cancer

• Registration Number: NCT00193284
• Lead Sponsor: SCRI Development Innovations, LLC

Brief Summary

Although gefitinib has been combined successfully with various chemotherapeutic regimens with minimal increase in overall toxicity, experience with concurrent radiation therapy is limited. In this trial, we will evaluate the feasibility, toxicity, and effectiveness a novel combination of chemotherapy, radiation therapy, and gefitinib.

Detailed Description

Upon determination of eligibility, patients will receive:

Induction Therapy

* Docetaxel

* Carboplatin

* 5-FU

* Gefitinib

Combined Modality Therapy

Cohort 1:

* Radiation therapy

* Gefitinib

Cohort 2:

* Radiation therapy

* Gefitinib

* Docetaxel

Study Timeline

• Study Start: 2003-10
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-19
• Primary Completion: 2006-02
• Status Verified: 2009-01
• Study Completion: 2009-01
• Last Update Submitted: 2010-06-18
• Last Update Posted: 2010-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

To be included in this study, you must meet the following criteria:

• Squamous carcinoma of the head and neck.
• Primary tumor nasopharynx, oral cavity, oropharynx, hypopharynx, and larynx
• Squamous carcinoma in cervical nodes no identified primary site
• Must be considered to have low cure rates with local therapy
• Previously untreated with chemotherapy or radiation therapy.
• Able to perform activities of daily living without assistance
• Adequate bone marrow, liver, and kidney function
• Mild peripheral neuropathy is allowed
• Measurable or evaluable disease
• Voluntarily give written informed consent.

Exclusion Criteria

You cannot participate in this study if any of the following apply to you:

• Age < 18 years
• History of prior malignancy within the last five years
• Severe or uncontrolled systemic disease
• Significant clinical disorder or laboratory finding
• Women who are pregnant or breast-feeding
• Active interstitial lung disease

Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Overall response rate

Secondary Outcome Measures

Name	Time	Method
Overall survival
Time to progression
Overall toxicity

Trial Locations

Locations (1)

Tennessee Oncology, PLLC; 🇺🇸 Nashville, Tennessee, United States