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

Completed · Phase 2

Conditions studied: Head and Neck Cancer

In brief

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.

Key facts

Study ID

NCT00193284

Run by

SCRI Development Innovations, LLC

People needed

50

Starts

2003-10-01

Expected to finish

2009-01-01

Last updated by the study team

2010-06-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Tennessee Oncology, PLLC — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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