ZD1839 (Iressa) for Recurrent or Metastatic Squamous Cell Carcinoma of the Skin
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- Number of Participants With Objective Response (Partial Response, Stable Disease and Progressive Disease) [ Time Frame: Every 8 weeks till disease progression. ] [ Designated as safety issue: No ]Responses were assessed according to the Union Internationale Contre le Cancer (UICC) / World Health Organization (WHO) criteria. Objective response (measurable response) defined as: Partial response (PR): Applies only to participants with at least 1 measurable lesion; >/=50% decrease under baseline in sum of products of perpendicular diameters of all measurable lesions. Stable Disease (SD): No progression of evaluable disease and/or no new lesions. Progressive Disease (PD): 50% increase or an increase of 10 cm2 (whichever is smaller) in the sum of products of all measurable lesions overall smallest sum observed (over baseline if no decrease) using the same techniques as baseline, OR clear worsening of any evaluable disease.
- Duration of Response [ Time Frame: Every 8 weeks till disease progression. ] [ Designated as safety issue: No ]Response duration was defined as the time from initial response during therapy to progression of disease.
|Study Start Date:||May 2004|
|Study Completion Date:||October 2012|
|Primary Completion Date:||October 2012 (Final data collection date for primary outcome measure)|
Experimental: Iressa (ZD1839)
Iressa (ZD1839) 250 mg by mouth daily.
250 mg by mouth daily
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 doctor.
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. Anderson.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00054691
|United States, Texas|
|UT MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Bonnie S. Glisson, MD, BS||M.D. Anderson Cancer Center|