A Phase II Study of ZD1839 (Iressa), Epidermal Growth Factor Receptor (EGFR) Tyrosine Kinase Inhibitor, in Treatment of Recurrent or Metastatic Squamous Cell Carcinoma of the Skin
ZD1839 is a new drug that may slow or stop cell growth in humans.
Epidermal growth factor receptor (EGFR) may be involved in certain types of cancer,
including squamous cell carcinoma of the skin. When EGFR is stimulated, a series of
chemical reactions starts that results in a tumor being "told" to grow. ZD1839 tries to
stop these reactions by blocking EGFR. This may stop tumors from growing.
In this study, participants will take ZD1839 by mouth daily. Once the treatment has
started, participants will return to the clinic before every treatment cycle (every 4 weeks)
for the first 4 months then every 8 weeks thereafter. At these visits, participants will
have a physical exam and blood tests will be performed. About 2-4 teaspoons of blood will
be drawn at each visit. The doctor will also check on how participants are tolerating
ZD1839 (side effects). Every 8 weeks, participants will have their tumor evaluated by
radiographic scans. This may include either a CT or MRI and a chest X-ray.
During treatment, participants should not take any other medication, including
non-prescription drugs such as aspirin or herbal products without the approval of their
Participants will continue taking the trial drug until the tumor grows, a severe side effect
occurs, they withdraw consent, or the study is closed. The study will be closed 12 months
after the last participant is enrolled.
This is an investigational study. The FDA has approved ZD1839 for the treatment of advanced
lung cancer, but the FDA has authorized ZD1839 for research only in the treatment of skin
cancer. About 40 participants will take part in this study. All will be enrolled at M.D.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of Participants with Objective Response
Participants with objective response (measurable response), defined as: Complete response (CR): Complete disappearance of all measurable and evaluable disease; Partial Response Partial response (PR): Applies only to participants with at least 1 measurable lesion; >/= to 50% decrease under baseline in sum of products of perpendicular diameters of all measurable lesions. For either response - No progression of evaluable disease. No new lesions. All measurable and evaluable lesions and sites assessed using same techniques as baseline. Tumor response assessed at completion of one course ZD1839 therapy (4 weeks), with repeat assessment 4 weeks later.
Bonnie S. Glisson, MD, BS
M.D. Anderson Cancer Center
United States: Institutional Review Board
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