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

SCRI Development Innovations, LLC1 site in 1 country50 target enrollmentOctober 2003

ConditionsHead and Neck Cancer

DrugsGefitinib Docetaxel Carboplatin Fluorouracil

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Head and Neck Cancer
Sponsor: SCRI Development Innovations, LLC
Enrollment: 50
Locations: 1
Primary Endpoint: Overall response rate
Status: Completed
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

October 2003

End Date

January 2009

Last Updated

15 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

SCRI Development Innovations, LLC

Eligibility Criteria

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

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.