A Phase II Trial Of ZD 1839 (IRESSA) (NSC #715055, IND #61187) In The Treatment Of Persistent Or Recurrent Endometrial Carcinoma
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
PROJECTED ACCRUAL: A total of 22-60 patients will be accrued for this study within 2.5-6
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Proportion of patients alive and progression-free
Gynecologic Oncology Group
United States: Food and Drug Administration
|Gynecologic Oncology Group||Philadelphia, Pennsylvania 19103|