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

Completed · Phase 2

Conditions studied: Endometrial Adenocarcinoma, Endometrial Adenosquamous Carcinoma, Endometrial Clear Cell Adenocarcinoma, Endometrial Serous Adenocarcinoma, Stage IA Uterine Corpus Cancer AJCC v7, Stage IB Uterine Corpus Cancer AJCC v7, Stage II Uterine Corpus Cancer AJCC v7, Stage IIIA Uterine Corpus Cancer AJCC v7, Stage IIIB Uterine Corpus Cancer AJCC v7, Stage IIIC Uterine Corpus Cancer AJCC v7, Stage IVA Uterine Corpus Cancer AJCC v7, Stage IVB Uterine Corpus Cancer AJCC v7

In brief

This phase II trial studies the side effects of giving intensity-modulated radiation therapy together with cisplatin and bevacizumab followed by carboplatin and cisplatin and to see how well they work in treating patients who have undergone surgery for high-risk endometrial cancer. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as cisplatin, carboplatin, and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block the ability of tumor cells to grow and spread. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving intensity-modulated radiation therapy together with chemotherapy and bevacizumab after surgery may kill any tumor cells that remain after surgery.

Key facts

Study ID

NCT01005329

Run by

National Cancer Institute (NCI)

People needed

34

Starts

2009-11-06

Expected to finish

2013-09-22

Last updated by the study team

2018-03-15

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

Where it is running

• Alta Bates Summit Medical Center-Herrick Campus — Berkeley, California, United States
• John Muir Medical Center-Walnut Creek — Walnut Creek, California, United States
• Penrose-Saint Francis Healthcare — Colorado Springs, Colorado, United States
• Poudre Valley Hospital — Fort Collins, Colorado, United States
• Christiana Care Health System-Christiana Hospital — Newark, Delaware, United States
• Baptist MD Anderson Cancer Center — Jacksonville, Florida, United States
• Integrated Community Oncology Network-Southside Cancer Center — Jacksonville, Florida, United States
• University of Florida Health Science Center - Jacksonville — Jacksonville, Florida, United States
• Baptist Medical Center South — Jacksonville, Florida, United States
• Integrated Community Oncology Network-Florida Cancer Center Beaches — Jacksonville Beach, Florida, United States
• 21st Century Oncology-Orange Park — Orange Park, Florida, United States
• 21st Century Oncology-Palatka — Palatka, Florida, United States
• Bay Medical Center — Panama City, Florida, United States
• Integrated Community Oncology Network-Flager Cancer Center — Saint Augustine, Florida, United States
• Northwestern University — Chicago, Illinois, United States
• John H Stroger Jr Hospital of Cook County — Chicago, Illinois, United States
• Saint Vincent Anderson Regional Hospital/Cancer Center — Anderson, Indiana, United States
• Saint Vincent Hospital and Health Care Center — Indianapolis, Indiana, United States
• Kansas City NCI Community Oncology Research Program — Prairie Village, Kansas, United States
• University of Maryland/Greenebaum Cancer Center — Baltimore, Maryland, United States
• Central Maryland Radiation Oncology in Howard County — Columbia, Maryland, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• Henry Ford Hospital — Detroit, Michigan, United States
• West Michigan Cancer Center — Kalamazoo, Michigan, United States
• Elliot Hospital — Manchester, New Hampshire, United States

Full record on ClinicalTrials.gov

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