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GOG-0229L: Fast Fact Sheet for Protocol 0229L (Endometrium) AMG 386 in Treating Patients With Persistent or Recurrent Endometrial Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=9A223983-7B94-E221-E040-BB89AD437E30

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https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=9A223983-7B94-E221-E040-BB89AD437E30

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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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Endometrial Cancer NCT01210222 Pre-Study - GOG-0229L: Fast Fact Sheet for Protocol 0229L (Endometrium) - 3184152v1.0

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  1. StudyEvent: GOG-0229L: Fast Fact Sheet for Protocol 0229L (Endometrium)
    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?
Is the cancer refractory to curative therapy or established treatments?
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?
How many prior cytotoxic chemotherapy regimens has the patient received? (NOTE: Chemotherapy administered in conjunction with primary radiation as a radio-sensitizer WILL be counted as a chemotherapy regimen.)
Performance Status (Patients who have received one prior regimen must have performance status of 0, 1 or 2 - patients who have received two prior regimens must have 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?
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 creatinine less than or equal to 1.5 X ULN or a creatinine clearance greater than or equal to 60 ml/m2?
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 Neuropathy (sensory or motor) less than or equal to CTCAE grade 1?
Is the urine protein less than or equal to 1 on dipstick (or if 2+ or higher, is urine protein less than 1.0g/24 hours)?
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?
Is the serum albumin greater than or equal to 2.8 mg/dL?
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?
If patient has the capacity to become pregnant, has she agreed to use an accepted and effective non-hormonal method of contraception i.e., double barrier method (eg. condom plus diaphragm) from the time of signing the informed consent through six months after the last dose of study drug?
Is the patient currently receiving or has she been treated previously with AMG 386, or other molecules that inhibit the angiopoietins or Tie2 receptor?
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 endometrial 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 endometrial 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 (including gastrointestinal), ulcer or bone fracture
Does the patient have symptoms of partial or complete bowel obstruction or a history of fistula, intra-abdominal abscess or bowel perforation within 6 months prior to first day of study therapy
Does the patient require total parenteral nutrition or parenteral hydration
Has the patient had significant bleeding within 6 months of enrollment or any 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?
Has the patient had clinically significant cardiovascular disease
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 myocardial infarction or unstable angina within the past 12 months
Using the New York Heart Association (NYHA) guideline, does the patient have Class II or greater congestive heart failure?
Does the patient have a history of serious ventricular arrhythmia (ventricular tachycardia or ventricular fibrillation) or arrhythmias requiring anti-arrhythmic medications (except for atrial fibrillation that is well controlled with anti-arrhythmic medication)?
Does the patient have peripheral vascular disease greater than or equal to Grade 2
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 a history of arterial ischemia or thrombus?
Has the patient undergone a major surgical procedure, open biopsy or incurred a significant traumatic injury within 28 days prior to the first date of study therapy?
Is a major surgical procedure anticipated for this patient during the course of this study
Has the patient had any minor surgical procedures, fine needle aspirates or core biopsies within 7 days prior to the first date of study therapy? (Paracentesis and thoracentesis are permitted prior to and while on study at the discretion of the investigator and as clinically indicated.)
Is the patient under age 18?
Is the patient pregnant or nursing?
Has the patient been treated with immune modulators such as systemic cyclosporine or tacrolimus within 30 days prior to enrollment?
Does the patient have human immunodeficiency virus (HIV), hepatitis C or chronic or active hepatitis B
Does the patient have any condition which in the investigator's opinion makes the patient unsuitable for study participation?
Is the patient available for follow-up assessments?
Does the patient have known sensitivity to any of the products to be administered during dosing?
Does the patient have a history of allergic reactions to bacterially produced proteins?
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