A Phase II Trial Of Oral Bicalutamide With Subcutaneous Goserelin In Patients With Epithelial Ovarian, Fallopian Tube, Or Peritoneal Carcinoma In Second Or Greater Remission
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 试验地点
- 2
研究概览
简要总结
RATIONALE: Some tumors need growth factors produced by the body's white blood cells to keep growing. Goserelin may interfere with the growth factor and may stop the tumor from growing. Bicalutamide may prevent androgens from stimulating the growth of cancer cells.
PURPOSE: Phase II trial to study the effectiveness of goserelin plus bicalutamide in treating patients who have refractory or recurrent cancer of the ovary, fallopian tube, or peritoneum.
详细描述
OBJECTIVES: I. Determine the time-to-treatment failure in patients with ovarian epithelial, fallopian tube, or peritoneal carcinoma, in second or greater remission, treated with bicalutamide and goserelin. II. Assess luteinizing hormone and follicle-stimulating hormone suppression in correlation with serum vascular endothelial growth factor levels, and determine if these levels are related to time to treatment failure in these patients. III. Correlate the presence or absence of androgen receptor tissue expression by immunohistochemistry and androgen receptor gene trinucleotide repeat length to time to treatment failure in these patients.
OUTLINE: Patients receive oral bicalutamide once daily and goserelin subcutaneously once every 4 weeks. Treatment continues in the absence of unacceptable toxicity until disease recurrence.
PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供