Conditions: Ovarian Cancer
Keywords: recurrent ovarian epithelial cancer
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 26
Healthy volunteers: no

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.

Arms:
arm 1: Fulvestrant 500 milligrams (mg) Day 1; 250 mg Day 1, 29 and every 28 days thereafter.

Interventions: intervention 1: Fulvestrant
Intervention descriptions: intervention 1: Fulvestrant, 500 milligrams (mg) intramuscularly (IM) on Day 1, 250 mg IM on Day 15, and 250 mg IM on Day 29 and every 28 days thereafter until either intolerance or disease progression.

Protocol document: