Dalantercept in Treating Patients With Recurrent or Persistent Endometrial Cancer

Inclusion Criteria

• •Patients must have recurrent or persistent endometrial carcinoma; histologic confirmation of the original primary tumor is required
• •* Patients with the following histologic epithelial cell types are eligible: Endometrioid adenocarcinoma, serous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, adenocarcinoma not otherwise specified (N.O.S.), mucinous adenocarcinoma, squamous cell carcinoma, and transitional cell carcinoma
• •All patients must have measurable disease; measurable disease is defined by Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.1) 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 or rare tumor protocol for the same patient population
• •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
• •Recovery from effects of recent surgery, radiotherapy, or chemotherapy
• •* 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; any investigational drug must be discontinued at least 30 days prior to registration
• •* Any prior radiation therapy must be discontinued at least four weeks prior to registration
• •* At least 4 weeks must have elapsed since the patient underwent any major surgery (e.g., major: laparotomy, laparoscopy); there is no delay in treatment for minor procedures (e.g., central venous access catheter placement)
• •Prior therapy
• •* Patients must have had one prior chemotherapeutic regimen for management of endometrial carcinoma. Initial treatment may include chemotherapy, chemotherapy and radiation therapy, and/or consolidation/maintenance therapy; chemotherapy administered in conjunction with primary radiation as a radio-sensitizer WILL be counted as a systemic chemotherapy regimen
• •* Patients are allowed to receive, but are not required to receive, one additional cytotoxic regimen for management of recurrent or persistent disease
• •* Patients must have NOT received any non-cytotoxic (biologic or targeted) agent(s) for management of recurrent or persistent disease; prior non-cytotoxic (biologic or targeted) agent(s) is allowed as part of initial treatment; prior hormonal therapy is allowed, but must be discontinued at least one week prior to registration
• •Absolute neutrophil count (ANC) greater than or equal to 1,500/mcL
• •Platelets greater than or equal to 100,000/mcL
• •Hemoglobin greater than or equal to 9 g/dL
• •Creatinine less than or equal to 1.5 times institutional upper limit normal (ULN)
• •Sodium greater than or equal to 130 mEq/L (Common Terminology Criteria for Adverse Events \[CTCAE\] v. 4, grade 0 or 1)
• •Urine protein should be screened by urinalysis; if protein is 2+ or higher, 24-hour urine protein should be obtained and the level should be \< 1,000 mg (\< 1.0 g/24 hrs) for patient enrollment
• •Bilirubin less than or equal to 1.5 times ULN
• •Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) less than or equal to 3 times ULN
• •Alkaline phosphatase less than or equal to 3 times ULN
• •Albumin greater than or equal to 3 (CTCAE v. 4, grade 0 or 1)
• •Prothrombin time (PT) such that international normalized ratio (INR) is less than or equal to 1.5 times ULN (or an in-range INR, usually between 2 and 3, if a patient is on a stable dose of therapeutic warfarin)
• •Partial thromboplastin time (PTT) less than or equal to 1.5 times ULN
• •Left ventricular ejection fraction (LVEF) greater than 50% (measured by echocardiogram or MUGA \[multi-gated acquisition\] scan)
• •Patients must have signed an approved informed consent and authorization permitting release of personal health information
• •Patients must meet pre-entry requirements
• •Patients of childbearing potential must have a negative serum pregnancy test prior to the study entry and be practicing an effective form of contraception