Bicalutamide and Goserelin in Treating Patients With Cancer of the Ovary, Fallopian Tube, or Peritoneum

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.

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Key information

Conditions

Fallopian Tube Cancer Adnexal Diseases Carcinoma Carcinoma, Ovarian Epithelial Endocrine Gland Neoplasms Endocrine System Diseases Fallopian Tube Diseases Fallopian Tube Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Ovarian Cancer Ovarian Diseases Ovarian Neoplasms Primary Peritoneal Cavity Cancer Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Memorial Sloan-Kettering Cancer Center

New York, 10021, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

DISEASE CHARACTERISTICS: Histologically confirmed epithelial carcinoma arising in the ovary, fallopian tube, or peritoneum, in second or greater remission Failed initial therapy with persistent or recurrent disease Cytoreductive surgery AND At least 1 platinum-based chemotherapy regimen No evidence of disease within 4 months of salvage chemotherapy CA-125 less than 35 U Negative physical exam No abdominal or pelvic disease by CT

PATIENT CHARACTERISTICS: Age: Adult Performance status: Karnofsky 60-100% Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin less than 2 times upper limit of normal (ULN) SGOT less than 2 times ULN Alkaline phosphatase less than 2 times ULN Renal: Not specified Other: No other active invasive malignancy No inability to receive subcutaneous injection No inability to tolerate oral medication

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: See Disease Characteristics Other: No concurrent oral anticoagulants

Treatment and study plan

bicalutamide

Drug

Goserelin acetate

Drug

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Collaborators

National Cancer Institute (NCI)

Registry information

Official study 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

Important dates

Study start: 2000
Primary completion: 2004
Study completion: 2004
First posted: Nov 11, 2003
Registry last updated: Jun 18, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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