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GOG-0227G: Fast Fact Sheet for Protocol 0227-G (Cervix) Brivanib in Treating Patients With Persistent or Recurrent Cervical Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=994603C2-7E97-D813-E040-BB89AD432944

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https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=994603C2-7E97-D813-E040-BB89AD432944

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  1. 8/27/12
  2. 1/9/15
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January 9, 2015

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Creative Commons BY-NC 3.0 Legacy
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Cervical Cancer NCT01267253 Pre-Study - GOG-0227G: Fast Fact Sheet for Protocol 0227-G (Cervix) - 3181753v1.0

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  1. StudyEvent: GOG-0227G: Fast Fact Sheet for Protocol 0227-G (Cervix)
    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
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 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?
Has the patient recovered from the effects of recent surgery, radiotherapy or chemotherapy?
Is the patient free of active infection requiring 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 prior therapy directed at the malignant tumor, including chemotherapy and immunologic agents, been discontinued for at least three weeks prior to registration?
Has any prior radiation therapy been completed at least 4 weeks prior to registration?
Has at least 4 weeks elapsed since the patient underwent any major surgery
Has the patient received one prior systemic chemotherapeutic regimen for management of advanced, metastatic or recurrent carcinoma of the cervix? (Chemotherapy administered concurrent with primary radiation e.g.; weekly cisplatin is not counted as a systemic chemotherapy regimen. Also, adjuvant chemotherapy given following the completion of radiation therapy or concurrent chemotherapy and radiation therapy is not counted as a systemic chemotherapy regimen.)
How many prior cytotoxic chemotherapy regimens has the patient received?
Performance Status (Patients who have received one prior regimen must have a performance status of 0, 1 or 2 - patients who have received two prior regimens must have a performance status of 0 or 1)
Has the patient received any non-cytotoxic (biologic or targeted) agents as part of their primary treatment or for management of recurrent or persistent disease? (Non-cytotoxic biologic or targeted agents include but are not limited to monoclonal antibodies, cytokines, and small-molecule inhibitors of signal transduction)
Platelets greater than or equal to 100,000/mcl?
ANC greater than or equal to 1,500/mcl?
Hemoglobin greater than or equal to 9 g/dL?
Is Serum Creatinine less than or equal to 1.5 X ULN
Does the patient have a urine protein of less than or equal to 2+ by dipstick or a 24-hour protein level of less than or equal to 3.5 g/24 hours?
Is the bilirubin less than or equal to 1.5 x ULN
Is the AST and ALT less than or equal to 3.0 X ULN
Is the alkaline phosphatase less than or equal to 2.5 x ULN?
Is the albumin greater than or equal to 2.5 g/dL?
Is Neuropathy (sensory and motor) less than or equal to CTCAE grade 1?
Is the prothrombin time such that the International Normalized Ratio (INR) is less than or equal to 1.5 X ULN?
Has the patient had a baseline electrocardiogram completed within 28 days prior to study entry and was the QTc found to be less than or equal to 450 msec?
Has the patient met the pre-entry requirements as specified in section 7.0
If the patient has childbearing potential, has she had a negative serum pregnancy test performed 48 hours prior to study entry?
Has the patient agreed to practice an effective form of contraception during the study and for at least three months after receiving the final treatment of Brivanib?
Has the patient had prior therapy with Brivanib or anti-vascular, anti-PDGFR (platelet-derived growth factor receptor) or anti-FGFR (fibroblast growth factor receptor) therapy?
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 had previous cancer treatment which contraindicates this protocol therapy
Has the patient received prior radiotherapy to any portion of the abdominal cavity or pelvis other than for the treatment of cervical cancer within the last three years?
Has the patient received prior radiation for localized cancer of the breast, head and neck or skin?
Was the prior radiation for localized cancer of the breast, head and neck or skin completed more than 3 years prior to registration and does the patient remain free of recurrent or metastatic disease?
Has the patient received prior chemotherapy for any abdominal or pelvic tumor other than for the treatment of cervical cancer within the last three years?
Has the patient received prior adjuvant chemotherapy for localized breast cancer?
Was the prior adjuvant chemotherapy for localized cancer of the breast completed more than 3 years prior to registration and does the patient remain free of recurrent or metastatic disease?
Does the patient require chronic anti-platelet therapy? (aspirin >300 mg/day or clopidogrel greater than or equal to 75 mg/day)
Has the patient experienced gastrointestinal bleeding or any other hemorrhage/bleeding event, Grade 3 or greater of the NCI CTCAE within 30 days prior to today?
Does the patient have a history of poor wound healing, non-healing ulcers or bone fractures within the last three months?
Has the patient had clinically significant cardiovascular disease
Has the patient had a myocardial infarction within 12 months of today?
Has the patient experienced uncontrolled angina within 12 months of today?
Using the New York Heart Association guidelines, does the patient have Class III-IV congestive heart failure?
Does the patient have uncontrolled hypertension defined as systolic greater than 140 mm Hg or diastolic greater than 90 mm Hg despite anti-hypertensive therapy?
Does the patient experience cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin?
Does the patient require the use of calcium channel blockers that are CYP3A4 inhibitors?
Does the patient have a history of stroke, TIA or other CNS ischemic event?
Has the patient had Left Ventricle Ejection Fraction (LVEF) testing done within 28 days of study entry and is the ejection fraction less than institutional LLN?
Does the patient have valvular heart disease greater than or equal to Grade 2?
Does the patient have a serious uncontrolled medical disorder or active infection which would impair the ability of the subject to receive protocol therapy or whose control may be jeopardized by the complications of this therapy?
Does the patient have a pre-existing thyroid abnormality with thyroid function that cannot be maintained in the normal range with medication?
Does the patient have hyponatremia (sodium less than 130 mEq/L)?
Does patient have a history of hepatitis B or hepatitis C infection
Does the patient have clinical evidence of brain metastases
Is the patient under age 18?
Is the patient pregnant or nursing?
Does the patient have untreated malabsorption syndrome?
Is the patient capable of taking and absorbing oral medications
Does the patient have a baseline serum potassium less than 3.5 mmol/L?
Is the patient receiving a stable dose of warfarin and has an in-range INR or receiving a stable dose of heparin
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