A Phase II Study of Bevacizumab in Combination With Definitive Radiotherapy and Cisplatin Chemotherapy in Untreated Patients With Locally Advanced Cervical Carcinoma
PRIMARY OBJECTIVES:
I. Determine treatment-related serious adverse-event rates and adverse-event rates within
the first 90 days from treatment start in patients with previously untreated locally
advanced carcinoma of the cervix treated with bevacizumab, cisplatin, and concurrent pelvic
radiotherapy.
SECONDARY OBJECTIVES:
I. Evaluate treatment-related serious adverse events and adverse events at any time.
II. Evaluate disease-free survival (local, regional, or distant failure, or death due to any
cause).
III. Evaluate overall survival (death due to any cause).
IV. To collect tissue to perform future immunohistochemical analyses for angiogenic markers
to correlate with clinical outcome; to collect tissue to perform future microarray testing
for evaluation of gene expression.
V. To collect urine and serum for future cytokine analysis.
VI. To implement the image-based brachytherapy guidelines proposed by the Transatlantic
Image-guided Brachytherapy Working Group and collect CT or MRI-based dosimetry of
brachytherapy applications used during the course of treatment for later analysis of
feasibility and consistency as well as dose/volume assessments of tumor control and
complications
OUTLINE: This is a multicenter study.
Patients undergo pelvic external-beam radiotherapy (EBRT) once daily, 5 days a week, for 5
weeks for a total of 45 Gy.
Some patients also undergo low-dose rate brachytherapy twice, 1-3 weeks apart, beginning >=
4 weeks after initiating EBRT or high-dose rate brachytherapy 5 times, >= 48 hours apart,
beginning >= 2 weeks after initiating EBRT. EBRT and chemotherapy are halted on the day of
high-dose rate brachytherapy. Patients receive bevacizumab IV over 30-90 minutes on days 1,
15, and 29 and cisplatin IV over 60 minutes on days 1, 8, 15, 22, 29, and 35.
After completion of study treatment, patients are followed periodically.
Interventional
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Subjects With Treatment-related Serious Adverse Events (SAEs) and Adverse Events (AEs) as Assessed by CTCAE v. 3.0 Criteria Within the First 90 Days From Treatment Start.
Treatment-related SAEs defined as Grade (Gr) >= 4 vaginal bleeding, Gr >=4 thrombotic event, Gr >=3 arterial event, gastrointestinal (GI) bleeding , or bowel/bladder perforation, and any Gr 5 treatment-related AE. Treatment-related AEs defined as all SAEs, Gr 3-4 nausea, vomiting, or diarrhea persisting for >2 weeks depsite medical intervention, Gr 4 neutropenia or leukopenia persisiting for >7 days, febrile neutropenia defined as a temperature >38.5 degree Celsius and granulocytes < 1000/mm3, Grade 3-4 hematologic toxicity with the exception of neutropenia and leukopenia, and Grade 3-4 GI, renal, cardiac, pulmonary, hepatic, or neurologic AEs. Based on a report by Laciano, et al. an SAE rate of 5% and AE rate of 35% were considered tolerable and an SAE rate >=20% and AE rate >=55% excessive. If there were >=6 pts with SAES or >=22 pts with AEs then the treatment would be rejected. This study design provides alpha of 0.05 and power of 90%.
From start of treatment to 90 days.
Yes
Tracey Schefter
Principal Investigator
American College of Radiology Imaging Network
United States: Food and Drug Administration
NCI-2009-00722
NCT00369122
August 2006
Name | Location |
---|---|
Roswell Park Cancer Institute | Buffalo, New York 14263 |
University of Florida Health Science Center | Gainesville, Florida 32610-0296 |
Northwest Community Hospital | Arlington Heights, Illinois 60005 |
Newark Beth Israel Medical Center | Newark, New Jersey 07112 |
Reading Hospital and Medical Center | Reading, Pennsylvania 19612-6052 |
LDS Hospital | Salt Lake City, Utah 84143 |
Boston Medical Center | Boston, Massachusetts 02118 |
Central Baptist Hospital | Lexington, Kentucky 40503 |
American Fork Hospital | American Fork, Utah 84003 |
Logan Regional Hospital | Logan, Utah 84321 |
Cottonwood Hospital Medical Center | Murray, Utah 84107 |
McKay-Dee Hospital Center | Ogden, Utah 84403 |
Brigham and Women's Hospital | Boston, Massachusetts 02115 |
Paoli Memorial Hospital | Paoli, Pennsylvania 19301-1792 |
Bryn Mawr Hospital | Bryn Mawr, Pennsylvania 19010 |
Lawrence Memorial Hospital | Lawrence, Kansas 66044 |
Menorah Medical Center | Overland Park, Kansas 66209 |
Shawnee Mission Medical Center | Shawnee Mission, Kansas 66204 |
North Kansas City Hospital | Kansas City, Missouri 64116 |
Research Medical Center | Kansas City, Missouri 64132 |
Saint Luke's East - Lee's Summit | Lee's Summit, Missouri 64086 |
Liberty Hospital | Liberty, Missouri 64068 |
Heartland Regional Medical Center | Saint Joseph, Missouri 64506 |
Clinton Memorial Hospital | Wilmington, Ohio 45177 |
Saint James Hospital and Health Centers Comprehensive Cancer Institute | Olympia Fields, Illinois 60461 |
Providence Medical Center | Kansas City, Kansas 66112 |
Independence Regional Health Center | Independence, Missouri 64050 |
Northwestern University | Chicago, Illinois 60611 |
University of Rochester | Rochester, New York 14642 |
Emory University | Atlanta, Georgia 30322 |
Albert Einstein Medical Center | Philadelphia, Pennsylvania 19141 |
Huntsman Cancer Institute/University of Utah | Salt Lake City, Utah 84112 |
UC Davis Comprehensive Cancer Center | Sacramento, California 95817 |
Lankenau Hospital | Wynnewood, Pennsylvania 19096 |
M D Anderson Cancer Center | Houston, Texas 77030 |
Wake Forest University Health Sciences | Winston-Salem, North Carolina 27157 |
John H Stroger Jr Hospital of Cook County | Chicago, Illinois 60612-3785 |
Radiation Oncology Practice Corporation Southwest | Overland Park, Kansas 66210 |
Radiation Oncology Practice Corporation - North | Kansas City, Missouri 64154 |
Saint Luke's Cancer Institute | Kansas City, Missouri 64111 |
Radiation Oncology Practice Corporation South | Kansas City, Missouri 64114 |
Saint Luke's Hospital of Kansas City | Kansas City, Missouri 64111 |
Saint Joseph Health Center | Kansas City, Missouri 64114 |
Liberty Radiation Oncology Clinic | Kansas City, Missouri 64116 |
Truman Medical Center | Kansas City, Missouri 64108 |
Highland Hospital | Rochester, New York 14620 |
Samaritan North Health Center | Dayton, Ohio 45415 |
Wright-Patterson Medical Center | Wright-Patterson Afb, Ohio 45433-5529 |
Mainline Health CCOP | Wynnewood, Pennsylvania 19096 |
University of Michigan University Hospital | Ann Arbor, Michigan 48109 |
Sandra L Maxwell Cancer Center | Cedar City, Utah 84720 |
Intermountain Medical Center | Murray, Utah 84157 |
Utah Valley Regional Medical Center | Provo, Utah 84603 |
Dixie Medical Center Regional Cancer Center | Saint George, Utah 84770 |
Intermountain Health Care | Salt Lake City, Utah 84103 |
Utah Cancer Specialists-Salt Lake City | Salt Lake City, Utah 84106 |
Grady Health System | Atlanta, Georgia 30303 |
Saint Luke's South Hospital | Overland Park, Kansas 66213 |
Saint Vincent Oncology Center | Indianapolis, Indiana 46260 |
Emory University Hospital Midtown | Atlanta, Georgia 30308 |
Cape Radiation Oncology | Cape Girardeau, Missouri 63703 |
The New York Methodist Hospital | Brooklyn, New York 11215 |