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



Status:Completed
Conditions:Cervical Cancer, Cancer, Cancer, Endometrial Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/17/2018
Start Date:November 6, 2009
End Date:September 22, 2013

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A Phase II Study of Postoperative Intensity Modulated Radiation Therapy (IMRT) With Concurrent Cisplatin and Bevacizumab Followed by Carboplatin and Paclitaxel for Patients With Endometrial Cancer

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.

PRIMARY OBJECTIVE:

I. To assess the treatment-related, grade 3+, non-hematologic adverse-event rate within 90
days from the start of treatment with concurrent intensity-modulated radiotherapy, cisplatin,
and bevacizumab followed by carboplatin and paclitaxel in patients with high-risk endometrial
cancer.

SECONDARY OBJECTIVES:

I. To evaluate treatment-related adverse events occurring within 1 year from the start of
treatment.

II. To evaluate all treatment-related adverse events. III. To evaluate disease-free and
overall survival. IV. To evaluate local, regional, and distant failure.

OUTLINE:

Patients undergo pelvic intensity-modulated radiotherapy (IMRT) once daily, 5 days a week,
for 5 weeks. Patients may also undergo optional nodal boost radiotherapy and/or vaginal
brachytherapy boost. Patients also receive concurrent cisplatin intravenously (IV) over 1
hour on days 1 and 29 and bevacizumab IV over 30-90 minutes on days 1, 15, and 29. Beginning
4-6 weeks after completing IMRT, cisplatin, and bevacizumab, patients receive carboplatin IV
over 1 hour and paclitaxel IV over 3 hours on day 1. Treatment with carboplatin and
paclitaxel repeats every 21 days for 4 courses in the absence of disease progression or
unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for 1 year,
every 6 months for 2 years, and then annually thereafter.

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
We found this trial at
39
sites
2000 Circle of Hope Dr
Salt Lake City, Utah 84112
(801) 585-0303
Huntsman Cancer Institute at University of Utah Huntsman Cancer Institute (HCI) is part of the...
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75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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Boston, MA
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655 West 8th Street
Jacksonville, Florida 32209
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Jacksonville, FL
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200 North Park Street
Kalamazoo, Michigan 49007
(269) 382-2500
West Michigan Cancer Center In 1994, Borgess Health Alliance and Bronson Healthcare Group opened the...
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Kalamazoo, MI
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Akron, OH
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Anderson, IN
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22 South Greene Street
Baltimore, Maryland 21201
410-328-7904
University of Maryland Greenebaum Cancer Center The University of Maryland Marlene and Stewart Greenebaum Cancer...
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Baltimore, MD
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155 5th St NE
Barberton, Ohio 44203
(330) 615-3000
Summa Barberton Hospital Summa Barberton Hospital is a full member of Summa Health System and...
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Berkeley, CA
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303 East Superior Street
Chicago, Illinois 60611
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1969 W Ogden Ave
Chicago, Illinois 60612
(312) 864-6000
John H. Stroger, Jr. Hospital of Cook County The Level 1 Trauma Center is one...
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Chicago, IL
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6001 E Woodmen Rd
Colorado Springs, Colorado 80923
(719) 776-5000
Penrose-Saint Francis Healthcare Founded by the Sisters of St. Francis and the Sisters of Charity,...
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2799 W Grand Blvd
Detroit, Michigan 48202
(313) 916-2600
Henry Ford Hospital Founded in 1915 by auto pioneer Henry Ford and now one of...
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1024 S Lemay Ave
Fort Collins, Colorado 80524
(970) 495-7000
Poudre Valley Hospital A 270-bed regional medical center offering a wide array of treatments, surgeries,...
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Houston, Texas 77030
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Indianapolis, Indiana 46260
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Jacksonville, Florida 32207
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Jacksonville, Florida 32258
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Manchester, New Hampshire 03103
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9200 W Wisconsin Ave
Milwaukee, Wisconsin 53226
(414) 805-3666
Froedtert and the Medical College of Wisconsin Froedtert Health combines with the Medical College of...
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4755 Ogletown-Stanton Road
Newark, Delaware 19718
302-733-1000
Christiana Care Health System - Christiana Hospital A 913-bed, 1.3-million-square-foot, modern facility in Newark, Delaware,...
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940 NE 13th St
Oklahoma City, Oklahoma 73190
(405) 271-6458
University of Oklahoma Health Sciences Center The OU Health Sciences Center is composed of seven...
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Orange Park, Florida 32073
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Palatka, Florida 32177
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Panama City, Florida 32401
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255 W Lancaster Ave
Paoli, Pennsylvania 19301
(484) 565-1000
Paoli Memorial Hospital Paoli is recognized regionally and nationally for outstanding medical and surgical services,...
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Philadelphia, Pennsylvania 19103
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101 Nicolls Rd
Stony Brook, New York 11794
(631) 444-4000
Stony Brook University Medical Center Stony Brook Medicine expresses our shared mission of research, clinical...
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5200 Harroun Rd
Sylvania, Ohio 43560
(419) 824-1444
Flower Hospital ProMedica's Mission is to improve your health and well-being. And ProMedica Flower Hospital...
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Walnut Creek, California 94598
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Wheeling, West Virginia 26003
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1 Medical Center Blvd
Winston-Salem, North Carolina 27157
336-716-2011
Wake Forest University Health Sciences Welcome to Wake Forest Baptist Medical Center, a fully integrated...
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Wynnewood, Pennsylvania 19096
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