Description:

GOG-0241: Fast Fact Sheet for Protocol 0241 (Ovary, Fallopian Tube) Carboplatin and Paclitaxel or Oxaliplatin and Capecitabine, With or Without Bevacizumab, as First-Line Therapy in Treating Patients With Newly Diagnosed Stage II, Stage III, Stage IV, or Recurrent Stage I Epithelial Ovarian Cancer or Fallopian Tube Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=8DA7C30C-FD52-1F06-E040-BB89AD430C14

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https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=8DA7C30C-FD52-1F06-E040-BB89AD430C14

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Versions (4) ▾
  1. 9/19/12
  2. 1/9/15
  3. 1/9/15
  4. 9/20/21
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September 20, 2021

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Creative Commons BY-NC 3.0 Legacy
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Fallopian Tube Cancer NCT01081262 Eligibility - GOG-0241: Fast Fact Sheet for Protocol 0241 (Ovary, Fallopian Tube) - 3128347v1.0

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  1. StudyEvent: GOG-0241: Fast Fact Sheet for Protocol 0241 (Ovary, Fallopian Tube)
    1. No Instruction available.
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8 more items in the detailed view.
Header
Did the patient sign an approved informed consent
Has HIPAA authorization been obtained?
Does the patient have a histologic diagnosis of mucinous adenocarcinoma of the ovary or Fallopian tube
What is the site of the disease
Does the patient have either Stage II-IV disease (no brain metastasis) or recurrent Stage I disease (chemonaive)?
If the patient is newly diagnosed, will protocol therapy begin within 6 weeks of primary debulking?
If the patient is stage I (Recurrent), will protocol therapy begin within 14 days of randomization?
Has the patient had appropriate surgery including appendectomy (unless patient has history of prior appendectomy) for ovarian or fallopian tube carcinoma with appropriate tissue available for histologic evaluation to confirm diagnosis and stage?
Does this patient have measurable disease as defined by RECIST 1.1 criteria for assessing clinical response to treatment OR non-measurable disease? (see Section 8.0 in the protocol)
Does the patient have measurable disease defined as any tumor lesion that can be accurately measured in at least one dimension with a minimum size of 1.0 cm by CT scan (CT scan slice thickness < 0.5 cm), 1.0 cm caliper measurement by clinical exam, 2.0 cm by chest X-ray, or 1.5 cm malignant, pathologically enlarged lymph node by CT scan?
What method of evaluation is used to obtain tumor measurements?
What is the size of the largest residual lesion?
Has the patient had a negative colonoscopy within one year of today?
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1000/uL
Is Serum Creatinine less than or equal to 1.5 X ULN
Is the Creatinine Clearance greater than 50 cc/min?
Is the bilirubin less than or equal to 1.5 X ULN
Are SGOT and Alkaline Phosphatase less than or equal to 2.5 times institutional ULN
Are sensory or motor neuropathy less than or equal to CTC Grade 1
Does the patient have one of the following: a urine dipstick for proteinuria less then 2+ OR If urine dipstick for proteinuria is greater then 2+, does the 24 hour urine demonstrate less then or equal to 1 g protein in 24 hours OR a urine protein-to-creatinine ratio (UPCR) less then or equal to 1.0 mg/dL?
Are PT and APTT less than or equal to 1.5 X ULN?
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Will the patient have the following paramenters measured within 14 days prior to initiating protocol therapy (Toxicity Assessment, Coagulation parameters PT, APTT, CBC, Differential, Platelets, Electrolytes, BUN, Creatinine, Calcium, Magnesium, Phosphorus, UPCR or Urinalysis, Bilirubin, SGOT, Alkaline Phosphatase, Total protein albumin, CA-125)
Will the patient have the following parameters measured within 28 days prior to initiating protocol therapy (History and Physical Exam, EKG, Radiographic tumor Measurement, Chest Imaging and Blood Pressure Measurement)
Has the patient met the pre-entry requirements as specified in section 7.0
Performance Status
Is the patient age 18 years or older
Does the patient have a life expectancy of greater than 3 months?
Does the patient have colon cancer or a history of colon cancer?
Does the patient have primary peritoneal carcinoma?
If the patient has had a prior invasive malignancy (except non-melanoma skin cancer), has she had any evidence of disease within the last 5 years or does the prior malignancy treatment contraindicate the current protocol therapy
Has the patient ever received chemotherapy or radiotherapy for any gynecologic or colorectal cancer prior to enrollment?
Does the treating physician anticipate the need for major surgical procedure during the course of the study? (See Section 3.25)
Will the patient have any minor surgical procedures, fine needle aspirates or core biopsies within 7 days prior to the first date of Bevacizumab therapy?
Has the patient had surgery (including open biopsy) within 4 weeks prior to anticipated first dose of bevacizumab (allowing for the fact that bevacizumab can be omitted from first cycle of chemotherapy)?
Does the patient have any evidence of wound disruption or impaired healing?
Does the patient have a history of abdominal fistula or perforation within the past 12 months?
Does the patient have a serious non-healing wound, ulcer, or bone fracture? (Patients with granulating incisions healing by secondary intention with no evidence of fascial dehiscence or infection are eligible but require weekly wound re-examinations - See Section 7.1 in the protocol.)
Does the patient have known hypersensitivity to Chinese hamster ovary cell products or other recombinant human or humanized antibodies
Does the patient have mixed epithelial ovarian cancer histology?
Does the patient have a tumor of low malignant potential?
Does the patient have a history or evidence upon physical examination of CNS disease, including brain tumor, seizures not controlled with standard medical therapy or any brain metastases?
Does the patient have uncontrolled hypertension defined as systolic pressure greater than 150mm Hg or diastolic greater than 100mm Hg?
Has the patient had myocardial infarction or unstable angina within 12 months of the first date of Bevacizumab therapy?
Using New York Heart Association (NYHA) guidelines, does the patient have Grade II or greater congestive heart failure or serious cardiac arrhythmia requiring medication?
Does the patient have Grade 1, Category 2 or greater, peripheral vascular disease?
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 Bevacizumab therapy?
Does the patient have a history of pulmonary embolism or deep vein thrombosis within the past 6 months?
Does the patient have a history of malabsorption or other conditions preventing oral treatment?
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?
Is the patient pregnant or nursing
Does the patient have acute hepatitis or active infection requiring parenteral antibiotics
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?
Is the patient taking warfarin?
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