Status:
COMPLETED
Chemotherapy Plus Gefitinib Followed by Chemotherapy, Radiation Therapy, and Gefitinib For Head and Neck Cancer
Lead Sponsor:
SCRI Development Innovations, LLC
Collaborating Sponsors:
AstraZeneca
Aventis Pharmaceuticals
Conditions:
Head and Neck Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 tri...
Detailed Description
Upon determination of eligibility, patients will receive: Induction Therapy * Docetaxel * Carboplatin * 5-FU * Gefitinib Combined Modality Therapy Cohort 1: * Radiation therapy * Gefitinib Cohor...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2003
Trial Type :
INTERVENTIONAL
End Date :
January 1 2009
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00193284
Start Date
October 1 2003
End Date
January 1 2009
Last Update
June 22 2010
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Tennessee Oncology, PLLC
Nashville, Tennessee, United States, 37023