Back to resultsSafety Trial of IRESSA, Cisplatin and Radiation Therapy for Patients With Head and Neck Cancer
Primary Purpose
Head and Neck Cancer
Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
ZD1839 (IRESSA)
Cisplatin
Radiation Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Head and Neck Cancer focused on measuring head and neck cancer, squamous cell carcinoma of the oral cavity, squamous cell carcinoma of the oropharynx, squamous cell carcinoma of the larynx, squamous cell carcinoma of the hypopharynx
Eligibility Criteria
Inclusion Criteria: Histologically confirmed squamous cell carcinoma of the oral cavity, oropharynx, larynx, or hypopharynx. For the Phase II portion of the study: measurable disease as based on RECIST criteria. Stage III or IV disease, M0. Life expectancy > 6 months. Exclusion Criteria: Known severe hypersensitivity to ZD1839 or any of the excipients of this product. Other co-existing malignancies or malignancies diagnosed within the last 5 years, with the exception of squamous cell carcinoma of the skin or cervical cancer in situ. Previous treatment with radiation, chemotherapy, or definitive surgical therapy. Distant metastatic disease. Documented evidence of HIV infection (because the interaction of ZD1839 with Highly Active Anti-Retroviral Therapy [HAART] is unknown). Substance abuse or psychiatric problems that would interfere with compliance. Pregnancy or breast-feeding (women of child-bearing potential). Treatment with a non-approved or investigational drug within 30 days before Day 1 of study treatment. Any evidence of clinically active interstitial lung disease (patients with chronic stable radiographic changes who are asymptomatic need not be excluded)
Sites / Locations
- Weill Medical College of Cornell University
Outcomes
Primary Outcome Measures
To explore whether the addition of ZD1839 to standard treatment of unresectable head and neck cancers (i.e., cisplatin and radiation therapy) improves the clinical complete response rate (as measured by RECIST criteria).
Secondary Outcome Measures
To determine the time to disease progression, duration of response, and 2?year disease-free survival in subjects with unresectable tumors of the head and neck after combined therapy with ZD1839, cisplatin, and radiation.
To determine the toxicities, and recovery from toxicities, of combined therapy with ZD1839, cisplatin, and radiation therapy.
To determine dose-limiting toxicity as well as the recommended Phase II dose of ZD1839 given concurrently with cisplatin and radiation.
Full Information
NCT ID
NCT00195078
First Posted
September 14, 2005
Last Updated
July 19, 2007
Sponsor
Weill Medical College of Cornell University
1. Study Identification
Unique Protocol Identification Number
NCT00195078
Brief Title
Safety Trial of IRESSA, Cisplatin and Radiation Therapy for Patients With Head and Neck Cancer
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2007
Overall Recruitment Status
Terminated
Study Start Date
April 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Weill Medical College of Cornell University
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer
Keywords
head and neck cancer, squamous cell carcinoma of the oral cavity, squamous cell carcinoma of the oropharynx, squamous cell carcinoma of the larynx, squamous cell carcinoma of the hypopharynx
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
29 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
ZD1839 (IRESSA)
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Type
Procedure
Intervention Name(s)
Radiation Therapy
Primary Outcome Measure Information:
Title
To explore whether the addition of ZD1839 to standard treatment of unresectable head and neck cancers (i.e., cisplatin and radiation therapy) improves the clinical complete response rate (as measured by RECIST criteria).
Secondary Outcome Measure Information:
Title
To determine the time to disease progression, duration of response, and 2?year disease-free survival in subjects with unresectable tumors of the head and neck after combined therapy with ZD1839, cisplatin, and radiation.
Title
To determine the toxicities, and recovery from toxicities, of combined therapy with ZD1839, cisplatin, and radiation therapy.
Title
To determine dose-limiting toxicity as well as the recommended Phase II dose of ZD1839 given concurrently with cisplatin and radiation.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histologically confirmed squamous cell carcinoma of the oral cavity, oropharynx, larynx, or hypopharynx. For the Phase II portion of the study: measurable disease as based on RECIST criteria.
Stage III or IV disease, M0.
Life expectancy > 6 months.
Exclusion Criteria:
Known severe hypersensitivity to ZD1839 or any of the excipients of this product.
Other co-existing malignancies or malignancies diagnosed within the last 5 years, with the exception of squamous cell carcinoma of the skin or cervical cancer in situ.
Previous treatment with radiation, chemotherapy, or definitive surgical therapy.
Distant metastatic disease.
Documented evidence of HIV infection (because the interaction of ZD1839 with Highly Active Anti-Retroviral Therapy [HAART] is unknown).
Substance abuse or psychiatric problems that would interfere with compliance.
Pregnancy or breast-feeding (women of child-bearing potential).
Treatment with a non-approved or investigational drug within 30 days before Day 1 of study treatment.
Any evidence of clinically active interstitial lung disease (patients with chronic stable radiographic changes who are asymptomatic need not be excluded)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roger Keresztes, M.D.
Organizational Affiliation
Weill Medical College of Cornell University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Weill Medical College of Cornell University
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
12. IPD Sharing Statement
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Safety Trial of IRESSA, Cisplatin and Radiation Therapy for Patients With Head and Neck Cancer
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