Intensity-Modulated Radiation Therapy, Cisplatin, and Bevacizumab Followed by Carboplatin and Paclitaxel in Treating Patients Who Have Undergone Surgery for Endometrial Cancer

This is an interventional treatment trial for Endometrial Adenocarcinoma Read More

Inclusion Criteria:

• Histologically confirmed endometrial cancer, including 1 of the following cellular types:

  • Endometrioid endometrial adenocarcinoma
  • Clear cell carcinoma
  • Papillary serous adenocarcinoma
  • Adenosquamous cell carcinoma
  • Other adenocarcinoma variant
• No carcinosarcoma

• Meets 1 of the following criteria:

  • Grade 3 carcinoma with > 50% myometrial invasion (stage IC or IIA) (all papillary serous or clear cell carcinoma will be considered grade 3)
  • Grade 2 or 3 carcinoma with any cervical stromal invasion (stage IIB)

  • Known extra-uterine disease confined to the pelvis (stage III or IVA)

    • Patients with stage III or IVA disease must have undergone computed tomography (CT) scan or positron emission tomography (PET)/CT scan of the abdomen and pelvis within the past 56 days
• Has undergone hysterectomy (i.e., total abdominal, vaginal, robotic-assisted, radical, or laparoscopic-assisted vaginal hysterectomy) and bilateral salpingo-oophorectomy within the past 56 days
• No positive common iliac or positive para-aortic nodal disease (defined as lymph nodes ? 2 cm in any dimension on CT scan or biopsy) or positive peritoneal cytology
• No evidence of metastatic extrauterine disease, gross or residual disease (not including pelvic nodal disease), or distant metastases
• Zubrod performance status 0-1
• Absolute neutrophil count (ANC) ? 1,500/mm^3 (without growth factor support)
• Platelet count ? 100,000/mm^3
• Hemoglobin ? 10 g/dL (transfusion allowed)
• Total bilirubin ? 1.5 times upper limit of normal (ULN)
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ? 2 times ULN
• Serum creatinine ? 1.5 mg/dL
• Urine protein:creatinine ratio ? 0.5 OR urine protein < 1,000 mg on 24-hour urine collection
• International normalized ratio (INR) < 1.5 (for patients treated with warfarin within the past 14 days)
• Not nursing
• No neuropathy ? Common Terminology Criteria for Adverse Events (CTCAE) grade 1
• No ototoxicity > CTCAE grade 2

• No serious, active comorbidity, including any of the following:

  • Unstable angina and/or New York Heart Association (NYHA) class II-IV congestive heart failure requiring hospitalization within the past 12 months
  • Transmural myocardial infarction within the past 12 months
  • Acute bacterial or fungal infection requiring IV antibiotics
  • Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy
  • Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
  • Acquired immune deficiency syndrome (AIDS) based upon current Center for Disease Control (CDC) definition (human immunodeficiency virus [HIV] testing is not required)
  • Active gastrointestinal (GI) ulcers, GI bleeding, inflammatory bowel disease, or GI obstruction
  • Inadequately controlled hypertension, defined as systolic blood pressure (BP) > 150 mm Hg and/or diastolic BP > 90 mm Hg on antihypertensive medications
  • Significant vascular disease, including aortic aneurysm, aortic dissection, or arteriovenous malformation within the past 12 months
  • Serious cardiac arrhythmia on medication (well-controlled atrial fibrillation on medication allowed)
  • Serious non-healing wound, ulcer, or bone fracture
• No history of hypertensive crisis or hypertensive encephalopathy
• No stroke/cerebrovascular event within the past 12 months
• No arterial thromboembolic events, including transient ischemic attack or clinically symptomatic peripheral artery disease within the past 12 months
• No abdominal fistula, GI perforation, or intra-abdominal abscess within the past 6 months
• No other invasive malignancies within the past 3 years other than nonmelanomatous skin cancer
• No significant trauma within the past 28 days
• No mental status changes or bladder problems that would preclude the ability to comply with bladder-filling instructions
• No mental or psychiatric illness that would preclude giving informed consent
• No known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies
• No prior allergic reaction to bevacizumab, cisplatin, carboplatin, or paclitaxel
• No concurrent erythropoietin, St. John's wort, therapeutic anticoagulants, aminoglycoside antibiotics, or amifostine
• No prior organ transplantation
• No prior external-beam radiotherapy to the pelvis resulting in overlapping of radiotherapy fields

• No prior systemic chemotherapy for uterine cancer

  • Prior chemotherapy for a different cancer is allowed
• No prior therapy with anti-vascular endothelial growth factor (VEGF) compounds
• More than 28 days since prior major surgical procedure requiring open biopsy incision
• No concurrent surgery (except for vascular access device placement or procedures that do not require significant incision)

• No concurrent warfarin at doses > 1 mg/day

  • Concurrent prophylactic low molecular weight heparin allowed