Copanlisib in Treating Patients With Persistent or Recurrent Endometrial Cancer

Inclusion Criteria

• •Patients must have the psychological ability and general health that permits completion of the study requirements and required follow-up
• •Women of child-bearing potential (WOCBP) must agree to use adequate contraception when sexually active; patients should continue contraception for 6 months after finishing study drug
• •Submission of tumor tissue is required for all patients; investigators should check with their site pathology department regarding release of biospecimens before approaching patients about participation in the trial
• •Patients must have recurrent or persistent endometrial cancer (endometrioid adenocarcinoma, serous adenocarcinoma, undifferentiated carcinoma, mixed epithelial carcinoma or adenocarcinoma not otherwise specified \[NOS\]); histologic confirmation of the primary tumor is required
• •All patients must have a somatic PIK3CA gene mutation (i.e., R88Q in exon 1, N345K in exon 4, C420R in exon 7, E542K, E545X \[E545A, E545D, E545G, and E545K\], Q546X \[Q546E, Q546K, Q546L, and Q546R\] in exon 9, and M1043I, H1047X \[H1047L, H1047R, and H1047Y\], or G1049R in exon 20) in a representative primary or metastatic tumor sample confirmed by the Roche COBAS PIK3CA Mutation Test at Q\^2 Solutions
• •All patients must have measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 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 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 have recovered from effects of recent surgery, radiotherapy, or chemotherapy; at least 4 weeks must have elapsed since the patient underwent any major surgery (e.g., major: laparotomy, laparoscopy); there is no delay required for minor procedures (e.g., tumor fine-needle aspiration \[FNA\] or core biopsy, venous access device placement)
• •Patients may have received prior radiation therapy for treatment of endometrial cancer; prior radiation therapy may have included pelvic radiation therapy, extended field pelvic/para-aortic radiation therapy, intravaginal brachytherapy and/or palliative radiation therapy; all radiation therapy must be completed at least 4 weeks prior to registration
• •Patients may have received prior hormonal therapy for treatment of endometrial carcinoma; all hormonal therapy must be discontinued at least 4 weeks prior to registration
• •Patients may have received prior therapy (including chemotherapy, biologic/targeted therapy and immunotherapy) for treatment of endometrial cancer; all therapy must be discontinued at least 4 weeks prior to registration; any investigational agent must be discontinued at least 30 days prior to registration
• •Patients must have had at least one prior chemotherapeutic regimen for management of endometrial carcinoma; initial treatment may include chemotherapy, chemotherapy and radiation therapy, 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 not required to receive, up to a total of 3 lines of chemotherapy
• •Appropriate stage for study entry based on the following diagnostic workup:
• •* History/physical examination within 28 days prior to registration
• •* Imaging of target lesion(s) within 28 days prior to registration
• •* Completion of pre-study protocol specific assessments as required
• •Performance status (Eastern Cooperative Oncology Group \[ECOG\]/Karnofsky) of 0, 1 or 2 within 28 days prior to registration
• •Absolute neutrophil count (ANC) \>= 1,500/mcl
• •Platelets \>= 75,000/mcl
• •Hemoglobin (Hgb) \>= 8 g/dL
• •Creatinine =\< 1.5 x upper limit of normal (ULN)
• •Bilirubin =\< 1.5 x ULN (=\< 3 x ULN for patients with Gilbert syndrome)
• •Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =\< 3 x ULN
• •Left ventricular ejection fraction (LVEF) \>= 50%
• •Fasting cholesterol less than or equal to 300 mg/dl; fasting triglycerides less than or equal to 300 mg/dl
• •Prothrombin time (PT) such that international normalized ratio (INR) is less than or equal to 1.5 x ULN (or an in range INR, usually between 2 and 3, if a patient is on a stable dose of therapeutic warfarin) and a partial thromboplastin time (PTT) less than or equal to 1.5 times the upper limit of normal
• •The patient must provide study-specific informed consent prior to study entry and, for patients treated in the United States (U.S.), authorization permitting release of personal health information
• •Diabetic patients (type I or II diabetes mellitus) must have baseline hemoglobin (Hb)A1c levels NOT higher than 8.5% at study entry
• •Patients with hypertension on medical management must have systolic blood pressure \< 150 mmHG or diastolic pressure \< 90 mmHG at study entry
• •Note: ULN is institutional or laboratory upper limit of normal
• •Women of child-bearing potential (WOCBP) must have a negative serum pregnancy test within 28 days of registration; the patient and her sexual partner(s) must agree to use adequate contraception when sexually active for the duration of the study and for 6 months after finishing study drug; a woman is considered of childbearing potential following menarche and until becoming post-menopausal unless permanently sterile; permanent sterilization methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy; a postmenopausal state is defined as no menses for 12 months without an alternative medical cause; a high follicle stimulating hormone (FSH) level in the postmenopausal range maybe used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy