Ignite Creation Date:
2024-05-05 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00195078
Status:
TERMINATED
Last Update Posted:
2007-07-20
First Post:
2005-09-14
Brief Title:
Safety Trial of IRESSA Cisplatin and Radiation Therapy for Patients With Head and Neck Cancer
Sponsor:
Weill Medical College of Cornell University
Organization:
Weill Medical College of Cornell University
Study Overview
Official Title:
Phase I-II Study of ZD1839 IRESSA Cisplatin and External-Beam Radiation Therapy in Patients With Locally Advanced Non-Metastatic Squamous Cell Carcinoma of the Head and Neck
Status:
TERMINATED
Status Verified Date:
2007-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to find out whether adding ZD1839 to standard treatment Cisplatin and Radiation Therapy of unresectable head and neck cancers is better than cisplatin and radiation alone
Detailed Description:
This is a Phase I-II open-label dose-escalation study in subjects with advanced head or neck cancer Subjects will receive daily ZD1839 during a course of standard radiation therapy accompanied by cisplatin
Subjects are adults with Stage III-IV squamous cell carcinoma of the oral cavity oropharynx larynx or hypopharynx who are in medically stable condition with an Eastern Cooperative Oncology Group ECOG Performance Status of 1 stable hepatic and bone marrow function and a life expectancy of at least 6 months Subjects should have no previous cancer history with the exception of squamous cell carcinoma of the skin or cervical cancer in situ and no prior treatment with radiation chemotherapy or definitive surgical therapy Subjects in the Phase II portion of the trial must have measurable disease as defined by RECIST criteria
Subjects are adults with Stage III-IV squamous cell carcinoma of the oral cavity oropharynx larynx or hypopharynx who are in medically stable condition with an Eastern Cooperative Oncology Group ECOG Performance Status of 1 stable hepatic and bone marrow function and a life expectancy of at least 6 months Subjects should have no previous cancer history with the exception of squamous cell carcinoma of the skin or cervical cancer in situ and no prior treatment with radiation chemotherapy or definitive surgical therapy Subjects in the Phase II portion of the trial must have measurable disease as defined by RECIST criteria
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None