Enzalutamide in Treating Patients with Advanced or Recurrent Androgen Receptor-Positive Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

Inclusion Criteria

• Advanced or recurrent epithelial ovarian, fallopian tube or primary peritoneal carcinoma; histologic documentation of the original primary tumor is required via the pathological report
• AR expression >= 5% by immunohistochemistry (IHC); in cases where multiple blocks are available staining will be performed on unstained slides from 3 separate blocks; if >= 5% AR tumor staining is seen on >= 1 slide the tumor will be considered to be AR+
• Patients with the following histologic cell types are eligible: serous adenocarcinoma, endometrioid adenocarcinoma, mucinous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial adenocarcinoma, transitional cell carcinoma, malignant Brenner's tumor, or adenocarcinoma not otherwise specified
• Measurable disease as defined by RECIST 1.1; measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension; each lesion must be >= 10 mm when measured by computed tomography (CT), magnetic resonance imaging (MRI) or caliper measurement by clinical exam; or >= 20 mm when measured by chest x-ray; lymph nodes must be >= 15 mm in short axis when measured by CT or MRI
• Patients must have had one prior platinum-based chemotherapy regimen for management of primary disease
• Patients may have received, but are not required to have received, one or two additional cytotoxic regimens for management of recurrent or persistent disease
• Patients who have received only one prior cytotoxic regimen (platinum-based regimen for management of primary disease), must have a platinum-free interval of less than 12 months, or have progressed during platinum-based therapy, or have persistent disease after a platinum-based therapy
• Patients are allowed to receive, but are not required to receive, non-cytotoxic therapy (such as bevacizumab) as part of their primary treatment regimen; patients are allowed to receive, but are not required to receive, non-cytotoxic therapy for management of recurrent or persistent disease
• Karnofsky performance status (KPS) of >= 70%
• Life expectancy of >= 12 weeks
• Women of child-bearing potential must have a negative pregnancy test within 14 days prior to commencement of study treatment
• Women of child-bearing potential must use an effective form of contraception during study and for at least 6 months after completion of study treatment
• Recovery from effects of recent surgery, radiotherapy, or chemotherapy * At least 4 weeks out from their last dose of radiation therapy * At least 4 weeks post-operative (op) from any major surgical procedure * At least 3 weeks out from their last dose of chemotherapy and/or biologic/targeted therapy
• No prior hormonal therapy for treatment of cancer within the past 21 days
• Absence of any psychological, familial, sociological or geographic condition that would potentially hamper compliance with the study protocol
• Prior use of or participation in a clinical trial evaluating and agent that either blocks androgen synthesis (e.g. abiraterone acetate, TAK-700, TAK-683, TAK-44) or targets the AR (e.g., bicalutamide, BMS-641988) (patients who are known to have only received placebo in these studies are eligible)
• Absolute neutrophil count (ANC) >= 1,000/mcL, within 14 days prior to initiation of study drug
• Platelets >= 100,000/mcL, within 14 days prior to initiation of study drug
• Hemoglobin >= 8 g/dL, within 14 days prior to initiation of study drug
• Creatinine =< 1.5 x upper limit of normal (ULN), within 14 days prior to initiation of study drug
• Bilirubin =< 1.5 x ULN, within 14 days prior to initiation of study drug
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x ULN, within 14 days prior to initiation of study drug
• Resolution of all acute toxicity effects of prior therapy to NCI CTCAE (version 4.0) grade =< 1, with the exception of unresolved grade 2 neuropathy and grade 2 alopecia, which are allowed
• Patients must be able to swallow tablets whole, without crushing

Exclusion Criteria

• A history of another invasive malignancy (other than non-melanoma skin cancer or curatively treated in situ carcinoma) with evidence of disease within the past 3 years
• Use of a medication known to lower the seizure threshold within 28 days of first dose of study drug
• Known brain metastasis
• History of seizure
• Uncontrolled hypertension (systolic blood pressure [BP] >= 160 mmHg or diastolic BP >= 95 mmHg) despite medical treatment; patients with a history of hypertension are allowed provided blood pressure is controlled by anti-hypertension treatment
• Clinically significant heart disease as evidenced by myocardial infarction or arterial thrombotic event within the past 6 months, severe or unstable angina, or New York Heart Association (NYHA) class II-IV heart disease or cardiac ejection fraction measurement of < 50% at baseline
• Refractory nausea and vomiting, requirement for parental hydration and/or nutrition, drainage gastrostomy tube, malabsorption, external biliary shunt, or significant small bowel resection that would preclude adequate study drug absorption
• Anticipated or ongoing administration of anti-cancer therapies other than those administrated in this study