A Phase II Trial of ZD 1839 (IRESSA) (NSC #715055) in the Treatment of Persistent or Recurrent Endometrial Carcinoma
Overview
- Phase
- Phase 2
- Intervention
- Gefitinib
- Conditions
- Recurrent Uterine Corpus Carcinoma
- Sponsor
- National Cancer Institute (NCI)
- Enrollment
- 56
- Locations
- 1
- Primary Endpoint
- Proportion of patients alive and progression-free
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Histologically confirmed primary endometrial carcinoma
- •Recurrent or persistent disease
- •Received 1 prior chemotherapy regimen for endometrial carcinoma
- •Initial treatment may include high-dose, consolidation, or extended therapy administered after surgical or nonsurgical assessment
- •At least 1 unidimensionally measurable lesion
- •At least 20 mm by conventional techniques (including palpation, plain x-ray, CT scan, and MRI)
- •At least 10 mm by spiral CT scan
- •Must have at least 1 target lesion for response assessment
- •Tumors within a previously irradiated field are designated as non-target lesions
- •Disease in a previously irradiated field as the only site of measurable disease is allowed only if there has been clear progression of the lesion since the completion of radiotherapy
Exclusion Criteria
- Not provided
Arms & Interventions
Treatment (gefitinib)
Patients receive oral gefitinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Intervention: Gefitinib
Treatment (gefitinib)
Patients receive oral gefitinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Intervention: Laboratory Biomarker Analysis
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Duration of progression-free survival(Up to 5 years)
- Duration of overall survival(Up to 5 years)
- Frequency of clinical response utilizing the Gynecologic Oncology Group (GOG) Response Evaluation Criteria in Solid Tumors (RECIST) criteria(Up to 5 years)
- Numerical descriptions of serum concentrations of gefitinib, gefitinib activity, and soluble epidermal growth factor receptor (EGFR)(Baseline to end of course 5)
- Initial performance status and histological grade(Baseline to end of course 5)