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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (planned)
• Sponsor: SCRI Development Innovations, LLC · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Head and Neck Cancer

Interventions

Type	Name	Description
DRUG	Gefitinib
DRUG	Docetaxel
DRUG	Carboplatin
DRUG	Fluorouracil

Timeline

• Start date: 2003-10-01
• Primary completion: 2006-02-01
• Completion: 2009-01-01
• First posted: 2005-09-19
• Last updated: 2010-06-22

Locations

1 site across 1 country: United States