Unesbulin in Treating Patients with Newly Diagnosed Unresectable Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Receiving Chemotherapy

Inclusion Criteria

• Patients with newly diagnosed epithelial ovarian, fallopian tube or primary peritoneal cancer and be previously untreated
• Patients with bulky disease that is considered by the clinician to be unresectable via primary debulking surgery and needs neoadjuvant chemotherapy prior to debulking surgery. This assessment of unresectability can be made via imaging or laparoscopic scoring
• Patients must have histologic diagnosis of epithelial ovarian, fallopian tube, or primary peritoneal carcinoma per pre-treatment biopsies by laparoscopy, or interventional radiology or computed tomography (CT) guided core biopsy. Histologic documentation of the original primary tumor is required via the pathology report
• Patients with the following histologic epithelial cell types are eligible: high grade serous adenocarcinoma, endometrioid adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, or adenocarcinoma not otherwise specified (N.O.S.)
• Absolute neutrophil count (ANC) greater than or to 1,500/mcl. This ANC cannot have been induced or supported by granulocyte colony stimulating factors
• Platelets greater than or equal to 100,000/mcl
• Creatinine =< 1.5 x institutional upper limit normal (ULN)
• Bilirubin =< 1.5 x ULN
• Serum glutamic-oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) and serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 3.0 x ULN
• Alkaline phosphatase =< 2.5 x ULN
• Neuropathy (sensory and motor) less than or equal to grade 1
• Patients should be free of active infection requiring parenteral antibiotics or a serious uncontrolled medical illness or disorder within four weeks of study entry
• Any hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to registration. Continuation of hormone replacement therapy is permitted
• Patients must have a performance status score of 0, 1, or 2 by Eastern Cooperative Group (ECOG) criteria
• Patients of childbearing potential must have a negative pregnancy test prior to the study entry and be practicing an effective form of contraception. If applicable, patients must discontinue breastfeeding prior to study entry
• Patients must have satisfactory results for the baseline laboratory analyses and diagnostic procedures as specified in the protocol
• Patients must be at least 18 years old
• Patients must have signed an Institutional Review Board (IRB)-approved informed consent and authorization permitting release of personal health information
• Patients must have pre-treatment tumor tissue available or agree for tissue collection from interventional radiology (IR) guided biopsy
• Life expectancy of at least 3 months

Exclusion Criteria

• Patients who have received prior treatment with unesbulin or standard of care drugs (cis- or carboplatin or paclitaxel)
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to unesbulin or other agents used in this study
• Patients who have a clinical requirement for ongoing systemic immunosuppressive therapy such as chronic steroid use not related to chemotherapy administration
• Patients receiving treatment for active autoimmune disease. “Active” refers to any condition currently requiring therapy. Examples of autoimmune disease include systemic lupus erythematosus, multiple sclerosis, inflammatory bowel disease and rheumatoid arthritis
• Patients with other invasive malignancies, with the exception of nonmelanoma skin cancer and other specific malignancies as noted in the protocol are excluded if there is any evidence of other malignancy being present within the last three years. Patients are also excluded if their previous cancer treatment contraindicates this protocol therapy. Patients with concomitant endometrial cancer diagnosed at the time of their ovarian cancer are allowed to participate if the endometrial cancer is Federation of Gynecology and Obstetrics (FIGO) stage IB or less
• Patients who have received prior radiotherapy to any portion of the abdominal cavity or pelvis are excluded. Prior radiation for localized cancer of the breast, head and neck, or skin is permitted, provided that it was completed more than three years prior to registration, and the patient remains free of recurrent or metastatic disease
• Patients who have received prior chemotherapy for any abdominal or pelvic tumor are excluded. Patients may have received prior adjuvant chemotherapy for localized breast cancer, provided that it was completed more than three years prior to registration, and that the patient remains free of recurrent or metastatic disease
• Patients with known active hepatitis, ongoing systemic bacterial, fungal, or viral infection; known human immunodeficiency virus (HIV) infection or acquired-immunodeficiency syndrome (AIDS)-related illness
• Patients with concurrent severe medical problems unrelated to the malignancy that would significantly limit full compliance with the study or expose the patient to extreme risk or decreased life expectancy
• Patients of childbearing potential, not practicing adequate contraception, patients who are pregnant, or patients who are breastfeeding are not eligible for this trial
• Patients with history or evidence upon physical examination of central nervous system (CNS) disease, including primary brain tumor, seizures not controlled with standard medical therapy, any brain metastases, or history of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) or subarachnoid hemorrhage within six months of the first date of treatment on this study
• Patients take concomitant therapy with any of the following: other non-study cytotoxic chemotherapy; other investigational therapies
• Prior bone marrow/hematopoietic stem cell transplantation
• History of solid organ, bone marrow, or progenitor cell transplantation
• History of major surgical procedure within 28 days prior to start of study treatment
• Presence or history of moderate to severe pulmonary dysfunction (e.g., moderate/severe chronic obstructive pulmonary disease, post-pneumonectomy, shortness of breath with limited exertion)
• Use of an investigational drug within 4 weeks of dosing in the current study