Back to resultsGefitinib (Iressa) in Combo With Chemoradiation in Patients With Locally Advanced Head & Neck Cancer
Primary Purpose
Head and Neck Neoplasms
Status
Completed
Phase
Phase 1
Locations
Finland
Study Type
Interventional
Intervention
Gefitinib
Cisplatin
Radiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Head and Neck Neoplasms focused on measuring Stage III Head and Neck Cancer, Stage IV Head and Neck Cancer
Eligibility Criteria
Inclusion Criteria: Histologically confirmed head and neck cancer Lymph node negative or positive Metastasis negative Chemo- and radiotherapy naïve WHO 0-2 Measurable disease by RECIST Written informed consent Exclusion Criteria: Severe alcohol abuse Active ILD Co-existing chronic gastrointestinal disease(s) Brain metastasis
Sites / Locations
- Research Centre
Outcomes
Primary Outcome Measures
Parts 1 and 2: Safety (Incidence of DLTs)
Part 3: Safety and tolerability
Secondary Outcome Measures
Parts 2 and 3: Efficacy (Incidence of complete response at 3 months after the end of trial treatment based on RECIST criteria)
Exploratory Outcome: EGFR-1 expression, amplification and activation Serum VEGF levels
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00239304
Brief Title
Gefitinib (Iressa) in Combo With Chemoradiation in Patients With Locally Advanced Head & Neck Cancer
Official Title
A Phase I/II Trial of ZD1839 (Iressa) Given Concurrently With Cisplatin and Radiotherapy in Patients With Locally Advanced Head and Neck Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
December 2007
Overall Recruitment Status
Completed
Study Start Date
June 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
AstraZeneca
4. Oversight
5. Study Description
Brief Summary
To determine the safety and tolerability of gefitinib in combination with cisplatin and radiation (3D-CRT or IMRT) in patients with locally advanced head and neck cancer.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Neoplasms
Keywords
Stage III Head and Neck Cancer, Stage IV Head and Neck Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Gefitinib
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Type
Procedure
Intervention Name(s)
Radiotherapy
Primary Outcome Measure Information:
Title
Parts 1 and 2: Safety (Incidence of DLTs)
Title
Part 3: Safety and tolerability
Secondary Outcome Measure Information:
Title
Parts 2 and 3: Efficacy (Incidence of complete response at 3 months after the end of trial treatment based on RECIST criteria)
Title
Exploratory Outcome: EGFR-1 expression, amplification and activation Serum VEGF levels
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histologically confirmed head and neck cancer
Lymph node negative or positive
Metastasis negative
Chemo- and radiotherapy naïve
WHO 0-2
Measurable disease by RECIST
Written informed consent
Exclusion Criteria:
Severe alcohol abuse
Active ILD
Co-existing chronic gastrointestinal disease(s)
Brain metastasis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AstraZeneca Finland Medical Director, MD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
Facility Name
Research Centre
City
Helsinki
Country
Finland
12. IPD Sharing Statement
Learn more about this trial
Gefitinib (Iressa) in Combo With Chemoradiation in Patients With Locally Advanced Head & Neck Cancer
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