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

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00193284

Enrollment

Registered

2005-09-19

Start date

2003-10-31

Completion date

2009-01-31

Last updated

2010-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head and Neck Cancer

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

Interventions

DRUGGefitinib

DRUGDocetaxel

DRUGCarboplatin

DRUGFluorouracil

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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/

Design outcomes

Primary

Measure	Time frame
Overall response rate	—

Secondary

Measure	Time frame
Overall toxicity	—
Overall survival	—
Time to progression	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026