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”

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.

Study Type: Interventional

Study Design: Treatment

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.

Intervention(s) in this Clinical Trial

• Drug: bicalutamide
• Drug: goserelin

• 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

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Memorial Sloan-Kettering Cancer Center

Overall Clinical Trial Officials and Contacts

Paul Sabbatini, MD Study Chair Memorial Sloan-Kettering Cancer Center  

Information obtained from ClinicalTrials.gov on January 06, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00012090

Study ID Number: CDR0000068483

ClinicalTrials.gov Identifier: NCT00012090

Health Authority: United States: Federal Government

Clinical trial summary from the National Cancer Institute's PDQ® database