Phase II Study of Skin Toxicity Dosing of IRESSA (Gefitinib) in Squamous Cell Carcinoma of the Head and Neck
Launched by UNIVERSITY OF CHICAGO · Aug 17, 2007
Trial Information
Current as of July 23, 2025
Completed
Keywords
ClinConnect Summary
This open-label, multi-institution, phase II study evaluated the activity of gefitinib at individually escalated doses up to 750mg to achieve the skin toxicity grade greater than or equal to 2. Patients were started on gefitinib 250mg orally daily for 2 weeks. At 2 weeks, patients were reevaluated and given skin toxicity grade according to the National Cancer Institute Common Toxicity Criteria version 3.0 (CTC 3.0). Patients with grade 2 or greater skin toxicity remained on 250 mg daily; in patients with grade 0-1 skin toxicity the dose was escalated to 500 mg daily and again to 750 mg dail...
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • squamous cell carcinoma of the head and neck
- • Tumour site that is amenable to biopsy. Patients can refuse biopsy and still participate in the study but all patients must have disease that can be biopsied
- • Aged 18 years or older
- • Prior epidermal growth factor receptor (EGFR) based therapy is allowed if greater than 4 months have elapsed since last dose of that agent and study entry
- • No chemotherapy or irradiation within the 28-day period preceding entry to the study.
- • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- • Ability to understand and the willingness to sign a written informed consent document.
- • Normal organ and marrow function
- Exclusion Criteria:
- • Known severe hypersensitivity to Iressa or any of the excipients of this product
- • Other co-existing malignancies or malignancies diagnosed within the last 3 years with the exception of basal cell carcinoma or cervical cancer in situ
- • Any unresolved chronic toxicity greater than CTC grade 2 from previous anticancer therapy (except alopecia).
- • Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the trial
- • Pregnancy or breast feeding women
- • Concomitant use of phenytoin, carbamazepine, rifampicin, barbiturates, or St John's Wort
- • 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
About University Of Chicago
The University of Chicago is a prestigious research institution renowned for its commitment to advancing medical science through innovative clinical trials. With a robust infrastructure that supports multidisciplinary collaboration, the University actively engages in cutting-edge research across various therapeutic areas. Its dedicated team of experienced investigators and state-of-the-art facilities enable the University of Chicago to conduct rigorous clinical studies aimed at improving patient outcomes and translating scientific discoveries into tangible healthcare solutions. The institution prioritizes ethical standards and patient safety, ensuring that all trials adhere to the highest regulatory guidelines and best practices in clinical research.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Chicago, Illinois, United States
Miami, Florida, United States
Chicago, Illinois, United States
Patients applied
Trial Officials
Ezra EW Cohen, MD
Principal Investigator
University of Chicago
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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