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