Phase II trial to study the effectiveness of gefitinib in treating patients who have persistent or recurrent endometrial cancer. Biological therapies such as gefitinib may interfere with the growth of tumor cells and slow the growth of endometrial cancer.
OBJECTIVES: I. Determine the 6-month progression-free survival of patients with persistent or recurrent endometrial carcinoma after receiving gefitinib. II. Determine the nature and degree of toxicity of this drug in these patients. III. Determine the progression-free and overall survival of patients treated with this drug. IV. Determine the effects of this drug on the levels of epidermal growth factor receptors (EGFR), c-ErbB2 (HER-2/neu) receptors, estrogen receptors (ER), and progesterone receptors (PR) (both PR and PRB) in tumor specimens of these patients. V. Determine if an association exists between the levels of EGFR, ER, PR, PRB, and HER-2/neu serum concentrations of gefitinib, gefitinib activity, and soluble EGFR and clinical outcome in patients treated with this drug. VI. Determine the frequency of clinical response (partial and complete response) in patients treated with this drug. OUTLINE: This is a multicenter study. Patients receive oral gefitinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 22-60 patients will be accrued for this study within 2.5-6 years.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
56
Given orally
Correlative studies
Gynecologic Oncology Group
Philadelphia, Pennsylvania, United States
Proportion of patients alive and progression-free
Time frame: 6 months
Frequency and severity of adverse effects as assessed by National Cancer Institute Common Toxicity Criteria (CTC) v2.0
Time frame: Up to 5 years
Duration of progression-free survival
Time frame: Up to 5 years
Duration of overall survival
Time frame: Up to 5 years
Frequency of clinical response utilizing the Gynecologic Oncology Group (GOG) Response Evaluation Criteria in Solid Tumors (RECIST) criteria
Time frame: Up to 5 years
Numerical descriptions of serum concentrations of gefitinib, gefitinib activity, and soluble epidermal growth factor receptor (EGFR)
Time frame: Baseline to end of course 5
Initial performance status and histological grade
Time frame: Baseline to end of course 5
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