Status:
TERMINATED
Safety Trial of IRESSA, Cisplatin and Radiation Therapy for Patients With Head and Neck Cancer
Lead Sponsor:
Weill Medical College of Cornell University
Conditions:
Head and Neck Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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 alon...
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 c...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2006
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT00195078
Start Date
April 1 2004
End Date
September 1 2006
Last Update
July 20 2007
Active Locations (1)
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1
Weill Medical College of Cornell University
New York, New York, United States, 10021