Irinotecan Liposome and Bevacizumab for the Treatment of Platinum Resistant, Recurrent, or Refractory Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Exclusion Criteria

• •Subjects must have recurrent, platinum resistant or refractory disease, defined as progression \< 6 months after completion of a platinum-based chemotherapy regimen or as persistent disease that remains after completion of a platinum-based therapy
• •Subjects must have measurable disease as assessed by RECIST 1.1
• •Subjects must have received at least 1 but no more than 3 prior platinum-based chemotherapy regimens
• •Subjects must have adequately recovered (in the opinion of the treating investigator) from adverse events due to prior anti-cancer therapy, with the exceptions of any grade alopecia and =\< grade 2 peripheral neuropathy per NCI-CTCAE version 5.0
• •Subjects must be age \>= 18 years
• •Subjects must exhibit an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
• •Hemoglobin \>= 9.0 g/dL (within =\< 28 days prior to registration)
• •White blood cell (WBC) count \>= 3.0 x 10\^9/L (within =\< 28 days prior to registration)
• •Absolute neutrophil count (ANC) \>= 1.5 x 10\^9/L (within =\< 28 days prior to registration)
• •Platelet count \>= 75 x 10\^9/L (within =\< 28 days prior to registration)
• •Serum total bilirubin =\< 1.5 x upper limit of normal (ULN) or direct bilirubin =\< ULN for subjects with total bilirubin levels \> 1.5 x ULN
• •Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\]) and alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \[SPGT\]) =\< 2.5 x ULN or =\< 5.0 x ULN for subjects with liver metastases
• •Serum albumin \>= 3.0 g/dL
• •Serum creatinine =\< 1.5 x ULN
• •Urine protein \< 2+ (urine dipstick) or \< 100 mg/dL (random protein urinalysis) or \< 1 g/24h (24 hour urine collection)
• •International normalized ratio (INR) =\< 1.5 x ULN or for subjects receiving anticoagulant therapy, INR must be within the therapeutic range of intended use of anticoagulants, as determined by the treating investigator
• •Activated partial thromboplastin Time (aPTT) =\< 1.5 x ULN or for subjects receiving anticoagulant therapy, aPTT must be within the therapeutic range of intended use of anticoagulants, as determined by the treating investigator
• •For subjects with a known history of human immunodeficiency virus (HIV), the HIV viral load must be undetectable for \>= 6 months prior to registration, and subjects must be receiving effective anti-retroviral HIV therapy, if indicated
• •* NOTE: HIV testing is not required for subjects without a known history of HIV, unless mandated by a local health authority
• •For subjects with a known history of hepatitis B virus (HBV) infection or hepatitis C virus (HCV) infection, the HBV/HCV viral load must be undetectable, and subjects must be receiving effective suppressive HBV/HCV therapy, if indicated.
• •* NOTE: HBV and HCV testing is not required for subjects without a known history of HBV or HCV, unless mandated by a local health authority
• •Exclusions for receipt of prior systemic anti-cancer therapy:
• •* Subjects must not have received any prior irinotecan-based therapies.
• •* Subjects must not have received more than 3 prior platinum-based chemotherapy regimens.
• •* Subjects must not have received more than 2 prior non-platinum, cytotoxic chemotherapy regimens.
• •* Note: Prior receipt of non-VEGF-targeting biological therapies is permitted. These may include but are not limited to hormonal therapies, immunotherapies, monoclonal antibodies (mAbs), tyrosine kinase inhibitors (TKIs), poly (ADP-ribose) polymerase (PARP) inhibitors, or other targeted agents. Refer to the below exclusion criterion for washout rules
• •Exclusions for washout from prior systemic anti-cancer therapy:
• •* Subjects must not have received chemotherapy, immunotherapy, monoclonal antibody (mAb) therapy, hormonal therapy, or other targeted therapy within =\< 14 days prior to registration.
• •* Subjects must not have received investigational agents or investigational devices within =\< 14 days prior to registration.
• •* Subjects must not have received VEGF-targeting agents, including bevacizumab, within =\< 6 months prior to registration
• •Subjects must not have received prior radiotherapy to the pelvis or abdomen within =\< 3 months prior to registration. Subjects must not have received prior radiotherapy to other areas within =\< 14 days prior to registration
• •Subjects must not have undergone a surgical procedure or jaw-invasive dental procedure (including tooth extraction) within =\< 28 days prior to registration
• •Subjects must not have a known history of hypersensitivity reactions attributed to compounds of similar chemical or biologic composition to bevacizumab, irinotecan liposome, or any of their excipients
• •Subjects must not have received hematologic growth factors and/or blood products (transfusions) within =\< 28 days prior to registration
• •Subjects must not be taking any of the medications listed as prohibited medications and therapies. Subjects receiving any medications or substances that are known strong CYP3A4 inducers, known strong CYP3A4 inhibitors, and/or known strong UGT1A1 inhibitors are ineligible.
• •* Known strong CYP3A4 inducers must be discontinued at least 2 weeks prior to initiation of irinotecan liposome to be eligible.
• •* Strong CYP3A4 inducers include, but are not limited to, the following: phenytoin, phenobarbital, primidone, carbamazepine, rifampin, rifabutin and rifapentine.
• •* Known strong CYP3A4 and UGT1A1 inhibitors must be discontinued at least 1 week prior to initiation of irinotecan liposome to be eligible.
• •* Strong CYP3A4 inhibitors include, but are not limited to, the following: ketoconazole, clarithromycin, indinavir, itraconazole, lopinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telaprevir, voriconazole. (Note: fosaprepitant is permitted).
• •* Strong UGT1A1 inhibitors include, but are not limited to, the following: atazanavir, gemfibrozil, indinavir and ketoconazole
• •* NOTE: Sites should refer to a current pharmacy reference manual for a full list of strong CYP3A4 inducers/inhibitors and strong UGTA1 inhibitors
• •Subjects must not have active peptic ulcer disease, active inflammatory bowel disease, active ulcerative colitis, or other active gastrointestinal condition with increased risk of perforation. Subjects must not have a history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within =\< 6 months prior to registration
• •Subjects must not have a history of bowel obstruction within =\< 6 months prior to registration. Subjects also must not have:
• •* Current evidence of tumor recto-sigmoid involvement by pelvic examination
• •* Current tumor bowel involvement on computed tomography (CT) scan
• •* Current clinical symptoms of bowel obstruction
• •Subjects must not have a history of a significant thromboembolic or vascular disorders within =\< 3 months prior to registration, including but not limited to:
• •* Pulmonary embolism
• •* Deep vein thrombosis
• •* Other arterial or venous thromboembolic events
• •* Cerebrovascular accident (CVA) or transient ischemic attack (TIA)
• •* Peripheral arterial ischemia \>= grade 3 (per NCI-CTCAE v5.0)
• •Subjects must not have a history of a significant bleeding disorder within =\< 6 months prior to registration, including but not limited to:
• •* Hematemesis, hematochezia, melena or other gastrointestinal bleeding \>= grade 2 (per NCI-CTCAE v5.0)
• •* Hemoptysis of 1/2 teaspoon (2.5 mL) or more of red blood, or other pulmonary bleeding \>= grade 2 (per NCI-CTCAE v5.0)
• •* Hematuria or other genitourinary bleeding \>= grade 2 (per NCI-CTCAE v5.0)
• •Subjects must not have a current non-healing wound, bone fracture, skin ulcer, or osteonecrosis of the jaw
• •Subjects must not be pregnant or expecting to conceive from the time of informed consent through 6 months after the last dose of trial treatment.
• •* NOTE: These subjects are excluded because there is an unknown but potential risk for adverse events to the developing fetus
• •Subjects must not have a known UGT1A1\* variant or Gilbert's syndrome
• •Subjects must not have received a live vaccine within =\< 30 days prior to registration.
• •* NOTE: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however, intranasal influenza vaccines (e.g., Flu-Mist) are live attenuated vaccines and are not allowed
• •Subjects must not have a condition or an uncontrolled intercurrent illness including, but not limited to any of the following:
• •* Ongoing or active infection requiring systemic treatment, except uncomplicated urinary tract infection (UTI) or uncomplicated upper respiratory tract infection (URI);
• •* Psychiatric illness/social situation that would limit compliance with study requirements;
• •* Any other illness or condition that the treating investigator feels would interfere with study compliance or would compromise the subject's safety or study endpoints