Spots Global Cancer Trial Database for Fulvestrant in Treating Patients With Recurrent Ovarian Epithelial Cancer

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Trial Identification

Brief Title: Fulvestrant in Treating Patients With Recurrent Ovarian Epithelial Cancer

Official Title: Phase II Trial of Fulvestrant in Treatment of Recurrent Ovarian Carcinoma

Study ID: NCT00617188

Conditions

Ovarian Cancer

Interventions

Fulvestrant

Study Description

Brief Summary: 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.

Detailed Description: 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.