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Brief Title: Bicalutamide and Goserelin in Treating Patients With Cancer of the Ovary, Fallopian Tube, or Peritoneum
Official Title: 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
Study ID: NCT00012090
Brief Summary: 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.
Detailed Description: 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Memorial Sloan-Kettering Cancer Center, New York, New York, United States
Name: Paul Sabbatini, MD
Affiliation: Memorial Sloan Kettering Cancer Center
Role: STUDY_CHAIR