Fulvestrant in Treating Patients With Recurrent Ovarian Epithelial Cancer

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 (<) 35 μ/mL but has risen progressively > 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