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
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.
Study Phase
Phase 2
Study Type
Interventional
Condition
Fallopian Tube Cancer
Intervention
bicalutamide
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Start Date
September 2000
Completion Date
April 2004
Primary Completion Date
April 2004
Eligibility Criteria
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
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Paul Sabbatini, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00012090
Organization ID
00-054
Secondary IDs
CDR0000068483
Study Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI)
Study Sponsor
Paul Sabbatini, MD, Study Chair, Memorial Sloan Kettering Cancer Center
Verification Date
June 2013