Phase II Study of Skin Toxicity Dosing of IRESSA (Gefitinib) in Squamous Cell Carcinoma of the Head and Neck
Condition: Head and Neck Neoplasms
MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck; Head and Neck Neoplasms
Intervention: Gefitinib
Intervention description: Patients were started on gefitinib 250 mg 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 250-mg oral dose-escalating dose; each patient received treatment at the dose that produced grade 2 skin toxicity until disease progression or withdrawal.
Intervention MeSH terms: Gefitinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 44.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: cancer; squamous cell; carcinoma; head; neck

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).
    

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