Ovarian Cancer Clinical Trial
Official title:
Phase II Trial of Fulvestrant in Treatment of Recurrent Ovarian Carcinoma
RATIONALE: Estrogen can cause the growth of ovarian epithelial cancer cells. Hormone therapy
using fulvestrant may fight ovarian cancer by blocking the use of estrogen by the tumor
cells.
PURPOSE: This phase II trial is studying how well fulvestrant works in treating patients with
recurrent ovarian epithelial cancer.
OBJECTIVES:
Primary
- To determine the 90-day clinical benefit (defined as the sum of complete responses,
partial responses, and stable disease) in patients with recurrent ovarian epithelial
cancer treated with single agent fulvestrant.
Secondary
- To establish the time to termination of treatment (due to all causes including
progression and intolerance) for patients treated with this drug.
- To describe the toxicities observed in patients treated with this drug.
- To evaluate the quality of life of patients treated with this drug.
- To determine the effect that prolonged estrogen receptor antagonism has on markers of
bone mineral turnover.
OUTLINE: Patients receive fulvestrant intramuscularly on days 1 and 15 of course 1 and then
on day 1 of all subsequent courses. Treatment repeats every 28 days for up to 1 year in the
absence of disease progression or unacceptable toxicity. Patients in continued response at
the end of 1 year may continue treatment at the discretion of the treating physician.
Urinary N-telopeptide and serum skeletal-specific alkaline phosphatase are assessed at
baseline and at 1, 3, and 6 months during study to determine the influence of estrogen
blockade on bone mineral turnover.
Quality of life is assessed at baseline and every 3 months during treatment, and at the end
of treatment using The Functional Assessment of Cancer Therapy - Ovarian (FACT-O) cancer
questionnaire.
After completion of study treatment, patients are followed at approximately 30 days.
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