- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00193284
Chemotherapy Plus Gefitinib Followed by Chemotherapy, Radiation Therapy, and Gefitinib For Head and Neck Cancer
A Phase I/II Trial of Induction Chemotherapy Plus Gefitinib (Iressa) Followed by Concurrent Chemotherapy, Radiation Therapy, and Gefitinib (Iressa) For Patients With Locally Advanced Squamous Carcinoma of the Head and Neck
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Tennessee
-
Nashville, Tennessee, United States, 37023
- Tennessee Oncology, PLLC
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Overall response rate
|
Secondary Outcome Measures
Outcome Measure |
---|
Time to progression
|
Overall survival
|
Overall toxicity
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms
- Neoplasms by Site
- Head and Neck Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Protein Kinase Inhibitors
- Docetaxel
- Carboplatin
- Fluorouracil
- Gefitinib
Other Study ID Numbers
- SCRI HN 04
- IRUSIRES0047
- IIT 15038
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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