fulvestrant in treating patients with recurrent ovarian epithelial cancer

Conditions: Ovarian Cancer

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.

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.

Eligibility criteria:
inclusion criteria: * histologically confirmed ovarian epithelial carcinoma * recurrent or persistent disease * must have received greater than or equal to (≥) 2 prior cytotoxic chemotherapy regimens, including ≥ 1 platinum-containing regimen * disease not amenable to curative treatment with surgery and/or radiotherapy * must have measurable disease according to response evaluation criteria in solid tumors (recist) and/or a serum cancer antigen 125 (ca-125) level that is rising and meets 1 of the following criteria: * serum ca-125 level greater than (\>) upper limit of normal (typically 35 μ/ml) on two evaluations at least 2 weeks apart * serum ca-125 level less than (\ 200% over successive specimens ≥ 2 weeks apart * estrogen receptor-positive tumor * gynecologic oncology group (gog) performance status 0-3 * platelet count ≥ 50 x 10\^9/liter * serum creatinine less than or equal to (≤) 2.5 mg/deciliter * bilirubin ≤ 1.5 times upper limit of normal (uln) * serum glutamic oxaloacetic transaminase (sgot) ≤ 3 times upper limit of normal (uln) * alanine aminotransferase (alt) or aspartate aminotransferase (ast) ≤ 2.5 times uln (≤ 5 times uln in the presence of liver metastases) * alkaline phosphatase ≤ 3 times uln * prothrombin time-international normalized ratio (inr) ≤ 1.6 * not pregnant or nursing * negative pregnancy test * must be sterile or fertile patients must use effective contraception (i.e., double method including ≥ 1 barrier, injectable, implantable, condoms plus spermicide) * prior malignancy allowed provided the patient has been disease-free for ≥ 5 years * patients with previously diagnosed basal cell skin cancer are eligible immediately after completing therapy * no history of bleeding (i.e., disseminated intravascular coagulation or clotting factor deficiency) * no documented sensitivity to active or inactive excipients of fulvestrant (i.e., castor oil or mannitol) * recovered from the effects of prior surgery, radiotherapy, and/or chemoradiotherapy * at least 3 weeks since prior chemotherapy * at least 3 weeks since prior complete radiotherapy regimen alone or chemoradiotherapy * an incomplete radiotherapy regimen (\< 500 gray) is allowed within the 3-week time frame exclusion criteria: * concurrent hormone replacement therapy * prior long-term anticoagulation therapy other than anti-platelet therapy

Keywords: recurrent ovarian epithelial cancer