Phase II Study of Skin Toxicity Dosing of IRESSA (Gefitinib) in Squamous Cell Carcinoma of the Head and Neck

• Status: Completed
• Trial end date: 2013-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Chicago
• Collaborator: AstraZeneca
• Treatments: Gefitinib

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