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Fast Fact Sheet for Protocol 0186-I (Ovary) Bevacizumab With or Without Fosbretabulin Tromethamine in Patients With Recurrent or Persistent Ovarian Epithelial, Fallopian Tube, or Peritoneal Cavity Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=9BF343E9-48AD-0577-E040-BB89AD437EA3

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https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=9BF343E9-48AD-0577-E040-BB89AD437EA3

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  1. 9/19/12
  2. 1/9/15
  3. 9/17/21
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September 17, 2021

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Creative Commons BY-NC 3.0 Legacy
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Fallopian Tube Cancer NCT01305213 Pre-Study - Fast Fact Sheet for Protocol 0186-I (Ovary) - 3190753v1.0

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  1. StudyEvent: Fast Fact Sheet for Protocol 0186-I (Ovary)
    1. No Instruction available.
Tracking Information
Header
Did the patient sign an approved informed consent
Has HIPAA authorization been obtained
Is the patient eligible for a higher priority GOG protocol
Is the patient under age 18?
What is the primary disease site
What is the cell type?
What was the grade of the primary tumor
Is the disease recurrent or persistent with documented progression? Which one?
How was it established to be recurrent or persistent?
Does the patient have measurable disease or detectable disease?
Does patient have measurable disease defined as at least one lesion that can be accurately measured in at least one dimension (longest dimension to be recorded) using RECIST 1.1 criteria?
What method of evaluation is used to obtain tumor measurements?
Is the measurable disease > or = 10 mm when measured by CT, MRI or caliper measurement by clinical exam; or > or = 20 mm when measured by chest x-ray or lymph nodes > or = 15 mm in short axis when measured by CT or MRI?
Does the patient have at least one target lesion to be used to assess response on this protocol as defined by RECIST 1.1?
Is the measurable disease in a previously irradiated field?
If yes, does the patient have disease in an irradiated field as the only site of measurable disease and has progression been documented or a biopsy obtained to confirm persistent disease at least 90 days following completion of radiation treatment?
How was detectable disease determined?
Has the patient recovered from the effects of recent surgery, radiotherapy or chemotherapy?
Is the patient free of acute hepatitis and active infection requiring parenteral antibiotics with the exception of uncomplicated urinary tract infection (UTI)?
Has any hormonal therapy directed at the malignant tumor been discontinued at least one week prior to registration?
Has all other prior therapy directed at the malignant tumor, including chemotherapy, biologic/targeted, and immunological agents, been discontinued for at least three weeks prior to today?
Have all chimeric or human or humanized monoclonal antibodies (including Bevacizumab) or VEGF receptor fusion proteins (including VEGF Trap/aflibercept) been discontinued for at least 12 weeks prior to today?
Will all investigational therapy be discontinued within 30 days prior to start of study treatment?
Has prior radiation therapy been discontinued for at least four weeks prior to registration?
Has the patient received one prior platinum-based chemotherapeutic regimen for management of primary disease containing carboplatin, cisplatin or another organoplatinum compound (may include intraperitoneal therapy, consolidation, non-cytotoxic agents, biologic/targeted agents, such as Bevacizumab) or extended therapy administered after surgical or non-surgical assessment?
How many cytotoxic regimens has the patient received for management of recurrent or persistent disease?
How many non-platinum, non-taxane regimens did the patient receive for recurrent or persistent disease?
Has the patient received any non-cytotoxic chemotherapy (biologic/targeted agents) for management of recurrent or persistent disease?
Performance Status (Patients who have received one prior regimen must have GOG performance status of 0, 1 or 2; patients who have received two or three prior regimens must must have GOG performance status of 0 or 1)
Has the patient received Bevacizumab for management of primary disease?
Is the platinum-free interval from the last platinum containing regimen greater than 6 months?
Did the patient have a documented recurrence (or disease progression) following (or during) her most recent course of platinum-based chemotherapy?
What was the PFI in months (period of time between the last dose of platinum-based chemotherapy and the first date of recurrence or progression)
What method of evaluation was used to determine that recurrence or progression?
g/dL
Is the creatinine less than or equal to 1.5 x ULN?
Is the potassium greater than or equal to 4.0 mEq/L (or mmol/L)?
Is the magnesium greater than or equal to 1.8 mmol/L?
Is the calcium greater than or equal to 8.4 mg/dL (or 2.0 mmol/L)?
Is the bilirubin less than or equal to 1.5 x ULN
Does the patient have a urine protein of less than 2+ on dipstick or a 24-hour urine protein of < 1000 mg (<1.0 g/24hrs)
Is the SGOT less than or equal to 3 X ULN
Is the alkaline phosphatase less than or equal to 2.5 x ULN?
Is the Prothrombin Time (PT) such that the International Normalized Ratio (INR) is:
Is the PTT less than or equal to 1.5 times the institutional upper limit of normal?
If the patient is of childbearing potential will she have a serum pregnancy test within 72 hours of starting protocol therapy and has she agreed to practice an effective form of birth control during study treatment and for six months after completion of treatment?
Has the patient met the pre-entry requirements as specified in section 7.0
Has the patient had prior treatment with fosbretabulin tromethamine or any other VDA?
Has the patient had another invasive malignancy other than non-melanoma of the skin, localized cancer of the breast, head and neck or skin diagnosed, present or recur within the past 3 years?
Has the patient received prior radiotherapy to any portion of the abdominal cavity or pelvis other than for the treatment of ovarian, fallopian tube or primary peritoneal cancer within the last three years? (Prior radiation for localized cancer of the breast, head and neck or skin is permitted as long as it was completed more than 3 years prior to registration and the patient remains free of recurrent or metastatic disease)
Has the patient received prior chemotherapy for any abdominal or pelvic tumor other than for the treatment of ovarian, fallopian tube or primary peritoneal cancer within the last three years? (Prior adjuvant chemotherapy for localized breast cancer is permitted provided it was completed more than 3 years prior to registration and the patient remains free of recurrent or metastatic disease)
Is the treatment of previous cancer a contraindication to the current protocol therapy?
Does the patient have a serious non-healing wound, ulcer or bone fracture?
Does the patient have a history of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess?
Did the abdominal fistula, gastrointestinal perforation or intra-abdominal abscess occur within 90 days of the first date of the therapy on this protocol?
Does the patient have active bleeding or pathologic conditions that carry high risk of bleeding such as known bleeding disorder, coagulopathy or tumor involving major vessels?
Does the patient have a history or evidence upon physical examination of CNS disease, including primary brain tumor, seizures not controlled with standard medical therapy or any brain metastases?
Does the patient have a history of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) or subarachnoid hemorrhage within six months of the first date of study therapy?
Does the patient have uncontrolled hypertension defined as systolic greater than 150 mm Hg or diastolic greater than 90 mm Hg despite anti-hypertensive therapy?
Does the patient have a history of torsade de pointes, ventricular tachycardia or fibrillation, pathologic sinus bradycardia (<60 bpm), heart block (1st degree block, being, PR interval prolongation only), congenital long QT syndrome, new ST segment elevation or depression or new Q waves on ECG?
Does the patient require any drug known to prolong QTc interval, including anti-arrhythmic medication?
Is the QTc interval greater than or equal to 470 msec?
Has the patient had a myocardial infarction or unstable angina within 6 months of the first date of study therapy?
Using the New York Heart Association (NYHA) guideline, does the patient have Class II or greater congestive heart failure?
Has the patient had clinically significant cardiovascular disease
Does patient have serious cardiac arrhythmia requiring medication (except for asymptomatic atrial fibrillation with controlled ventricular rate)?
Has the patient received prior treatment with an anthracycline? (including Doxorubicin or Pegylated liposomal Doxorubicin [Doxil, PLD])
If yes, has the patient had an echocardiogram assessment and is the LVEF less than 50%?
Does the patient have CTCAE Grade 2 or greater peripheral vascular disease? (Note: at least brief less than 24 hours episodes of ischemia managed non-surgically and without permanent deficit.)
Does the patient have known hypersensitivity to any components of fosbretabulin tromethamine or bevacizumab?
Has the patient had a major surgical procedure within 28 days prior to the first date of treatment on this study?
Is a major surgical procedure anticipated for this patient during the course of this study
Will a core biopsy be done within 7 days prior to the start of study drug?
Does the patient have clinical symptoms or signs of gastrointestinal obstruction and require parenteral hydration and/or nutrition
Does the patient have any condition which in the investigator's opinion makes the patient unsuitable for study participation?
Is the patient pregnant or nursing?
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