Phase
Condition
Ovarian Cysts
Fallopian Tube Cancer
Adenocarcinoma
Treatment
N/AClinical Study ID
Ages > 18 Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Patients must have histologic diagnosis of epithelial ovarian, fallopian tube, orprimary peritoneal carcinoma which is now recurrent; histologic documentation of theoriginal primary tumor is required via the pathology report
Patients with the following histologic epithelial cell types are eligible: high-gradeserous adenocarcinoma, endometrioid adenocarcinoma, undifferentiated carcinoma, clearcell adenocarcinoma, mixed epithelial carcinoma or adenocarcinoma not otherwisespecified (N.O.S.)
Patients must have recurrence documented by elevated cancer antigen (CA)-125 (biochemical recurrence) or clinically evident measurable or non-measurable recurrentdisease
Biochemical recurrence is defined as a CA-125 greater than or equal to two timesthe upper normal limit; patients whose CA-125 is less than 100 U/mL must undergoa second confirmatory value within a period of not more than 4 weeks; patientswith a level greater than or equal to 100 U/mL may be entered withoutconfirmatory measurement; the CA-125 assessment for eligibility must be done atleast 4 weeks after paracentesis or other surgical procedures
Detectable (non-measurable) disease is defined as symptomatic ascites or pleuraleffusions, solid and/or cystic abnormalities on radiographic imaging that do notmeet Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 definitions fortarget lesions and/or biopsy proven recurrence
Measurable disease will be defined by RECIST 1.1; measurable disease is definedas 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 bycomputed tomography (CT), magnetic resonance imaging (MRI) or caliper measurementby 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 with measurable disease must have had at least one "target lesion" to beused to assess response on this protocol as defined by RECIST 1.1; tumors withina previously irradiated field will be designated as "non-target" lesions unlessprogression is documented or a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy
Absolute neutrophil count (ANC) greater than or equal to 1,500/mcl
This ANC cannot have been induced or supported by granulocyte colony-stimulatingfactors
Platelets greater than or equal to 100,000/mcl
Creatinine =< 1.5 times institutional upper limit of normal (ULN)
Bilirubin < 1.2 times ULN
Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) andserum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 3.0times ULN
Alkaline phosphatase =< 2.5 times ULN
Left ventricular ejection fraction (LVEF) greater than or equal to institutional lowerlimit of normal (LLN) as determined by gated cardiac radionucleotide scan (MUGA) orechocardiogram
Neuropathy (sensory and motor) less than or equal to grade 1
Patients must have a platinum-free interval following initial platinum-basedchemotherapy of at least 6 months at first recurrence; front-line therapy may haveincluded a biologic/targeted agent (e.g., bevacizumab)
NOTE: Front-line treatment may have included maintenance therapy; patientsreceiving maintenance therapy (biological therapy, hormonal, or taxane therapy)are ELIGIBLE provided their platinum-free interval is at least 6 months frominitial chemotherapy AND a minimum of 4 weeks has elapsed since their last doseof biologic/targeted or taxane therapy or a minimum of 1 week has elapsed sincetheir last dose of hormonal therapy
Patients must have a Gynecologic Oncology Group (GOG) performance status of 0 or 1
Patients of childbearing potential must have a negative pregnancy test prior to thestudy entry and be practicing an effective form of contraception; if applicable,patients must discontinue breastfeeding prior to study entry
Patients who have met the pre-entry requirements
Patients must have signed an Institutional Review Board (IRB)-approved informedconsent and authorization permitting release of personal health information
ADDITIONAL CRITERIA FOR PATIENTS BEING TREATED ON BEVACIZUMAB COHORT
Prothrombin time (PT) such that international normalized ratio (INR) is =< 1.5 X ULN (or an in-range INR, usually between 2 and 3, if a patient is on a stable dose oftherapeutic warfarin) and a partial thromboplastin time (PTT) < 1.5 X ULN
Urine protein should be screened by urine analysis; if protein is 2+ or higher, 24-hour urine protein should be obtained and the level should be < 1000 mg for patientenrollment
Patients treating with enoxaparin are eligible for inclusion in the study
Fertile women must agree to use adequate contraceptive measures during study therapyand for at least 6 months after the completion of bevacizumab therapy; should a womanbecome pregnant or suspect she is pregnant while she or her partner is participatingin this study, the patient should inform the treating physician immediately
Exclusion
Exclusion Criteria:
Patients who have received more than one previous regimen of chemotherapy (maintenanceis not considered a second regimen)
Patients who have received prior ABT-888 or any other poly-adenosine diphosphate (ADP)--ribose polymerase (PARP) inhibitor
Patients who have received prior PLD
History of allergic reactions attributed to compounds of similar chemical or biologiccomposition to ABT-888 or other agents used in this study
Patients with other invasive malignancies, with the exception of non-melanoma skincancer and other specific malignancies are excluded if there is any evidence of othermalignancy being present within the last three years; patients are also excluded iftheir previous cancer treatment contraindicates this protocol therapy
Patients who have received prior radiotherapy to any portion of the abdominal cavityor pelvis are excluded; prior radiation for localized cancer of the breast, head andneck, or skin is permitted, provided that it was completed more than three years priorto registration, and the patient remains free of recurrent or metastatic disease
Patients who have received prior chemotherapy for any abdominal or pelvic tumor (otherthan ovarian, fallopian tube and primary peritoneal) are excluded; patients may havereceived prior adjuvant chemotherapy for localized breast cancer, provided that it wascompleted more than three years prior to registration, and that the patient remainsfree of recurrent or metastatic disease
Patients with synchronous primary endometrial cancer or a history of endometrialcancer, unless all of the following conditions are met:
Stage not greater than IB
No more than superficial myometrial invasion
No vascular or lymphatic invasion
No poorly differentiated subtypes, including papillary serous, clear cell, orother International Federation of Gynecology and Obstetrics (FIGO) grade 3lesions
Patients with known chronic or active hepatitis or ongoing or active infection thatrequires parenteral antibiotics
Patients with concurrent severe medical problems unrelated to the malignancy thatwould significantly limit full compliance with the study or expose the patient toextreme risk or decreased life expectancy
Patients of childbearing potential, not practicing adequate contraception, patientswho are pregnant or patients who are breastfeeding are not eligible for this trial
Patients with seizures or a history of seizures are ineligible
Patients with history or evidence upon physical examination of central nervous system (CNS) disease, including primary brain tumor, any CNS metastases, or history ofcerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) orsubarachnoid hemorrhage within six months of the first date of treatment on thisstudy; patients with CNS metastases must be stable for > 3 months after treatment andoff steroid treatment prior to study enrollment
Patients who cannot swallow pills
ADDITIONAL CRITERIA FOR PATIENTS BEING TREATED ON BEVACIZUMAB COHORT:
History of allergic reactions attributed to compounds of similar chemical or biologiccomposition to bevacizumab
Pregnant women are excluded from this study; breastfeeding should be discontinued ifthe mother is treated with bevacizumab
Human immunodeficiency virus (HIV)-positive patients on combination antiretroviraltherapy are ineligible
Urine protein should be screened by urine analysis; if protein is 2 + or higher, 24-hour urine protein should be obtained and the level should be < 1000 mg for patientenrollment
Serious non-healing wound, ulcer, or bone fracture
History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscesswithin 6 months to day 1
Invasive procedures defined as follows:
Major surgical procedure, open biopsy or significant traumatic injury within 28days prior to day 1 therapy
Anticipation of need for major surgical procedures during the course of the study
Core biopsy within 7 days prior to day 1 (D1) therapy
Significant vascular disease (e.g., aortic aneurysm, requiring surgical repair orrecent peripheral arterial thrombosis) within 6 months prior to day 1
Known CNS disease except for treated brain metastases; treated brain metastases aredefined as having no ongoing requirement for steroids and no evidence of progressionor hemorrhage after treatment for at least 3 months, as ascertained by clinicalexamination and brain imaging (magnetic resonance imaging [MRI] or computed tomography [CT]); (stable dose of anticonvulsants are allowed); treatment for brain metastasesmay include whole brain radiotherapy (WBRT), radiosurgery (RS; Gamma Knife, LINAC, orequivalent) or a combination as deemed appropriate by the treating physician; patientswith CNS metastases treated by neurosurgical resection or brain biopsy performedwithin 3 months prior to Day 1 will be excluded
Patients with clinically significant cardiovascular disease are excluded
Inadequately controlled hypertension (HTN) (systolic blood pressure [SBP] > 160mm Hg and/or diastolic blood pressure [DBP] > 90 mm Hg despite antihypertensivemedication)
History of cerebrovascular accident (CVA) within 6 months
History of myocardial infraction or unstable angina within 6 months
New York Heart Association grade II or greater congestive heart failure
Serious and inadequately controlled cardiac arrhythmia
Significant vascular disease (e.g. aortic aneurysm, history of aortic dissection)
Clinically significant peripheral vascular disease
Evidence of bleeding diathesis or coagulopathy
Patients with known hypersensitivity to Chinese hamster ovary cell products or otherrecombinant human antibodies
Study Design
Study Description
Connect with a study center
Gynecologic Oncology Group of Arizona
Phoenix, Arizona 85012
United StatesSite Not Available
University of California Medical Center At Irvine-Orange Campus
Orange, California 92868
United StatesSite Not Available
University of Colorado Cancer Center - Anschutz Cancer Pavilion
Aurora, Colorado 80045
United StatesSite Not Available
Augusta University Medical Center
Augusta, Georgia 30912
United StatesSite Not Available
University of Chicago Comprehensive Cancer Center
Chicago, Illinois 60637
United StatesSite Not Available
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa 52242
United StatesSite Not Available
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland 21287
United StatesSite Not Available
Memorial Sloan-Kettering Cancer Center
New York, New York 10065
United StatesSite Not Available
Case Western Reserve University
Cleveland, Ohio 44106
United StatesSite Not Available
Cleveland Clinic Foundation
Cleveland, Ohio 44195
United StatesSite Not Available
Ohio State University Comprehensive Cancer Center
Columbus, Ohio 43210
United StatesSite Not Available
Hillcrest Hospital Cancer Center
Mayfield Heights, Ohio 44124
United StatesSite Not Available
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma 73104
United StatesSite Not Available
Gynecologic Oncology Group
Philadelphia, Pennsylvania 19103
United StatesSite Not Available
Women and Infants Hospital
Providence, Rhode Island 02905
United StatesSite Not Available
Froedtert and the Medical College of Wisconsin
Milwaukee, Wisconsin 53226
United StatesSite Not Available

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