Alisertib in Treating Patients With Recurrent or Persistent Leiomyosarcoma of the Uterus

Inclusion Criteria

• Patients must have incurable recurrent or persistent uterine leiomyosarcoma; histologic confirmation of the original primary tumor is required
• Patients must have measurable disease; measurable disease is defined by Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.1); measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded); 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 at least one "target lesion" to be used to assess response on this protocol as defined by RECIST version 1.1; tumors within a previously irradiated field will be designated as "non-target" lesions unless progression is documented or a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy
• Patients must not be eligible for a higher priority Gynecologic Oncology Group (GOG) protocol, if one exists; in general, this would refer to any active GOG phase III protocol for the same patient population (12/10/2012)
• Patients who have received one prior regimen must have a GOG performance status of 0, 1, or 2; patients who have received two prior regimens must have a GOG performance status of 0 or 1
• Patients should be free of active infection requiring antibiotics (with the exception of uncomplicated urinary tract infection [UTI])
• Any hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to registration
• Any other prior therapy directed at the malignant tumor, including chemotherapy and immunologic agents, must be discontinued at least three weeks prior to registration (12/10/2012)
• Any prior radiation therapy must be discontinued at least four weeks prior to registration (12/10/2012)
• Patients must have had at least one prior chemotherapeutic regimen for management of leiomyosarcoma
• Patients are allowed to receive, but are not required to receive, one additional cytotoxic regimen for management of recurrent or persistent disease (12/10/2012)
• Patients must NOT have received any prior therapy directed at Aurora kinase for management of recurrent or persistent disease; patients who were treated on GOG-0250 (gemcitabine + docetaxel plus bevacizumab vs placebo) are eligible; treatment on GOG-0250 would count as ONE prior regimen
• Leukocytes >= 3,000/mcL
• Absolute neutrophil count >= 1,500/mcL
• Platelets >= 100,000/mcL
• Serum creatinine = = 60 mL/min/1.73m^2 (calculated or measured)
• Bilirubin =< ULN
• Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 3 x ULN
• Alkaline phosphatase =< 2.5 x ULN
• Patients must have signed an approved informed consent and authorization permitting release of personal health information
• Patients of childbearing potential must have a negative serum pregnancy test prior to the study entry and be practicing an effective form of contraception; pregnant women are excluded from this study
• Patients must be able to take oral medication and to maintain a fast for 2 hours before and 1 hour after MLN8237 administration
• Patient must not have taken agents that effect gastric pH within 4 days (any proton pump inhibitor), or 1 day (any histamine-2 antagonist) of the planned start of therapy; patients must be able to avoid all other types of antacids for 2 hours before and 2 hours after each dose of MLN8237

Exclusion Criteria

• Patients who have had prior therapy with MLN8237 or taken part in a study of an investigational compound or device within 4 weeks of entering this study
• Patients who have had surgery (excluding biopsy), radiotherapy, or chemotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to the planned start of protocol treatment or those who hav