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GOG-0229K: Fast Fact Sheet for Protocol 0229-K (Endometrium) BIBF 1120 in Treating Patients With Recurrent or Persistent Endometrial Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=99D51BE9-A450-39B5-E040-BB89AD43255D

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https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=99D51BE9-A450-39B5-E040-BB89AD43255D
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  1. 12/18/14 12/18/14 - Martin Dugas
  2. 1/9/15 1/9/15 - Martin Dugas
  3. 9/17/21 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 NCT01225887 Pre-Study - GOG-0229K: Fast Fact Sheet for Protocol 0229-K (Endometrium) - 3183206v1.0

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  1. StudyEvent: GOG-0229K: Fast Fact Sheet for Protocol 0229-K (Endometrium)
    1. No Instruction available.
Tracking Information
Header
Did the patient sign an approved informed consent
Is the SGOT less than or equal to 3 X ULN (regardless of the presence of liver metastases)
Has HIPAA authorization been obtained
Is the patient eligible for a higher priority GOG protocol
What is the site of the disease
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 treatment?
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?
Performance Status
Does the patient have normal thyroid function?
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 immunologic agents, been discontinued for at least three weeks prior to registration?
Has the patient received one prior chemotherapeutic regimen for management of endometrial carcinoma?
How many prior cytotoxic chemotherapy regimens has the patient received?
Has the patient received any non-cytotoxic chemotherapy 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?
Is the creatinine less than or equal to 1.5 X ULN
Is the bilirubin less than or equal to 1.5 x ULN (regardless of the presence of liver metastases)
Is SGPT (ALT) less than or equal to 3.0 X Upper Limits of Normal
Is the alkaline phosphatase less than or equal to 2.5 x ULN? (regardless of the presence of liver metastases)
Is her urine protein creatinine (UPC) ratio less than 1 (or urinary 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?
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? (ventricular tachycardia must be less than 3 beats in a row or ventricular fibrillation)
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 within 14 days prior to initiation protocol therapy
If patient has the capacity to become pregnant, has she agreed to use adequate contraception (two barrier methods of birth control) prior to study entry and for the duration of the study and up to three months after the final dose of BIBF1120?
Has the patient received prior therapy with BIBF1120?
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?
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 endometrial 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?
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, intra-abdominal abscess within 28 days prior to first day of study therapy or an underlying lesion(s) that caused the fistula or perforation in the past that have not been corrected?
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, 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
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, 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
Has the patient had clinically significant cardiovascular disease
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?
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?
Does the patient have an ejection fraction of less than institutional LLN?
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 valvular heart disease greater than or equal to Grade 2?
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?
Is the patient under age 18?
Is the patient pregnant or nursing?
Does the patient have a history of major thromboembolic event defined as: symptomatic pulmonary embolism (PE), recurrent asymptomatic PE, or recurrent deep vein thrombosis?
Has the patient had prior thrombosis or thromboembolic event due to a known inherited coagulopathy? (ie, antithrombin-III deficiency, Protein C or Protein S deficiency, Factor V Leiden mutation presence, prothrombin G20210A mutation )
Has the patient had serious infections requiring systemic antibiotics or antiviral therapy including: known active Hepatitis B or C infection; known HIV infection?
Has the patient been treated with immune modulators such as systemic cyclosporine or tacrolimus within 30 days prior to enrollment?
Does the patient have a history of photosensitivity or must she take agents which increase photosensitivity?
Does the patient have the ability to swallow oral medication
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