Chemotherapy Plus Gefitinib Followed by Chemotherapy, Radiation Therapy, and Gefitinib For Head and Neck Cancer

Head and Neck Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00193284
• Other study ID #: SCRI HN 04
• Secondary ID: IRUSIRES0047IIT
• Status: Completed
• Phase: Phase 2
• First received: September 12, 2005
• Last updated: June 18, 2010
• Start date: October 2003
• Est. completion date: January 2009

Study information

• Verified date: January 2009
• Source: SCRI Development Innovations, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 2009
• Est. primary completion date: February 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

Drug:
• Gefitinib

• Docetaxel

• Carboplatin

• Fluorouracil

Locations

Country	Name	City	State
United States	Tennessee Oncology, PLLC	Nashville	Tennessee

Sponsors (3)

Lead Sponsor	Collaborator
SCRI Development Innovations, LLC	AstraZeneca, Aventis Pharmaceuticals

Country where clinical trial is conducted

United States, 

References & Publications (1)

Hainsworth JD, Spigel DR, Burris HA 3rd, Markus TM, Shipley D, Kuzur M, Lunin S, Greco FA. Neoadjuvant chemotherapy/gefitinib followed by concurrent chemotherapy/radiation therapy/gefitinib for patients with locally advanced squamous carcinoma of the head — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall response rate
Secondary	Overall survival
Secondary	Time to progression
Secondary	Overall toxicity

External Links

•   Published article in Cancer