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

Primary Purpose

Head and Neck Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Gefitinib
Docetaxel
Carboplatin
Fluorouracil
Sponsored by
SCRI Development Innovations, LLC
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head and Neck Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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/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.

Sites / Locations

  • Tennessee Oncology, PLLC

Outcomes

Primary Outcome Measures

Overall response rate

Secondary Outcome Measures

Overall survival
Time to progression
Overall toxicity

Full Information

First Posted
September 12, 2005
Last Updated
June 18, 2010
Sponsor
SCRI Development Innovations, LLC
Collaborators
AstraZeneca, Aventis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00193284
Brief Title
Chemotherapy Plus Gefitinib Followed by Chemotherapy, Radiation Therapy, and Gefitinib For Head and Neck Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2009
Overall Recruitment Status
Completed
Study Start Date
October 2003 (undefined)
Primary Completion Date
February 2006 (Actual)
Study Completion Date
January 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
SCRI Development Innovations, LLC
Collaborators
AstraZeneca, Aventis Pharmaceuticals

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Gefitinib
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Intervention Type
Drug
Intervention Name(s)
Fluorouracil
Primary Outcome Measure Information:
Title
Overall response rate
Secondary Outcome Measure Information:
Title
Overall survival
Title
Time to progression
Title
Overall toxicity

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John D. Hainsworth, MD
Organizational Affiliation
SCRI Development Innovations, LLC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tennessee Oncology, PLLC
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37023
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19288572
Citation
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 and neck. Cancer. 2009 May 15;115(10):2138-46. doi: 10.1002/cncr.24265.
Results Reference
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Chemotherapy Plus Gefitinib Followed by Chemotherapy, Radiation Therapy, and Gefitinib For Head and Neck Cancer

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