Phase II Study of Skin Toxicity Dosing of IRESSA (Gefitinib) in Squamous Cell Carcinoma of the Head and Neck
Completed · Phase 2
Conditions studied: Head and Neck Neoplasms
In brief
The purpose of this study is to demonstrate the activity (response rate and rate of stable disease) of Iressa administered as a single agent escalated to a dose that produces grade 2 skin toxicity in patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck (SCCHN).
Key facts
- Study ID
- NCT00519077
- Run by
- University of Chicago
- People needed
- 44
- Starts
- 2005-03-01
- Expected to finish
- 2013-05-01
- Last updated by the study team
- 2016-07-01
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- University of Miami Sylvester Comprehensive Cancer Center — Miami, Florida, United States
- Northwestern University — Chicago, Illinois, United States
Full record on ClinicalTrials.gov
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