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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


Phase 2
18 Years
N/A
Not Enrolling
Female
Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Paul Sabbatini, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Federal Government

Study ID:

00-054

NCT ID:

NCT00012090

Start Date:

September 2000

Completion Date:

April 2004

Related Keywords:

  • Fallopian Tube Cancer
  • Ovarian Cancer
  • Primary Peritoneal Cavity Cancer
  • recurrent ovarian epithelial cancer
  • fallopian tube cancer
  • primary peritoneal cavity cancer
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021