Phase II Feasibility Trial Incorporating Bevacizumab Into Dose Dense Doxorubicin and Cyclophosphamide Followed by Paclitaxel in Patients With Lymph Node Positive Breast Cancer
PRIMARY OBJECTIVES:
I. Determine the incidence of clinically apparent cardiac dysfunction in patients with
resected lymph node-positive breast cancer treated with adjuvant bevacizumab and dose dense
doxorubicin and cyclophosphamide followed by paclitaxel.
SECONDARY OBJECTIVES:
I. Determine the changes in left ventricular ejection fraction (LVEF) in patients treated
with this regimen.
II. Determine the non-cardiac toxicity of this regimen in these patients.
OUTLINE: This is a non-randomized, multicenter study. Patients are sequentially assigned to
1 of 2 treatment arms.
ARM A: Patients receive doxorubicin IV, cyclophosphamide IV over 20-30 minutes, and
bevacizumab IV over 30-90 minutes on day 1. Patients also receive filgrastim (G-CSF)
subcutaneously (SQ) on days 2-11 or pegfilgrastim SC on day 2. Treatment repeats every 14
days for 4 courses. Patients then receive paclitaxel IV over 3 hours and bevacizumab IV over
30-90 minutes on day 1. Patients also receive G-CSF or pegfilgrastim as above. Treatment
with paclitaxel, bevacizumab, and G-CSF or pegfilgrastim repeats every 14 days for 4
courses. Patients then receive bevacizumab alone every 14 days for up to 18 courses.
ARM B: Patients receive doxorubicin, cyclophosphamide, and G-CSF or pegfilgrastim as in
group I. Patients then receive paclitaxel, bevacizumab, and G-CSF or pegfilgrastim as in
group I. Patients then receive bevacizumab alone every 14 days for up to 22 courses.
Treatment in both groups continues in the absence of disease recurrence or unacceptable
toxicity.
Patients who require radiotherapy (post-lumpectomy) or who plan radiotherapy at the
discretion of the investigator (post-mastectomy) undergo radiotherapy beginning within 6
weeks after the completion of chemotherapy.
Premenopausal patients with estrogen receptor (ER) and / or progesterone receptor (PR)
positive disease receive oral tamoxifen once daily for 5 years beginning at the time of
radiotherapy or within 6 weeks after the completion of chemotherapy. Postmenopausal patients
with ER and / or PR positive disease receive an aromatase inhibitor (e.g., anastrozole,
letrozole, or exemestane) or tamoxifen followed by an aromatase inhibitor once daily for up
to 10 years.
After completion of study treatment, patients are followed every 3 months for 2 years and
then every 6 months for up to 3 years from study entry.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Congestive Heart Failure Rate
Clinical congestive heart failure includes patients with symptomatic decline in LVEF to at or below the lower limit of normal (LLN), or symptomatic diastolic dysfunction. 223 treated patients were included in the analysis.
assessed on day 1 of cycles 5, 9, 17 and 25, and at end of treatment, then every 3 months for <2 years and every 6 months for 2-3 years from study entry
Yes
Kathy Miller, MD
Study Chair
Indiana University Melvin and Bren Simon Cancer Center
United States: Federal Government
NCI-2012-02977
NCT00119262
October 2005
September 2009
Name | Location |
---|---|
George Washington University Medical Center | Washington, District of Columbia 20037 |
Mayo Clinic - Jacksonville | Jacksonville, Florida 32224 |
Mayo Clinic Cancer Center | Rochester, Minnesota 55905 |
Indiana University Cancer Center | Indianapolis, Indiana 46202-5265 |
CCOP - Wichita | Wichita, Kansas 67214-3882 |
Hurley Medical Center | Flint, Michigan 48503 |
CCOP - Missouri Valley Cancer Consortium | Omaha, Nebraska 68131 |
CCOP - Carle Cancer Center | Urbana, Illinois 61801 |
CCOP - Iowa Oncology Research Association | Des Moines, Iowa 50309-1016 |
Beth Israel Deaconess Medical Center | Boston, Massachusetts 02215 |
CCOP - Metro-Minnesota | Saint Louis Park, Minnesota 55416 |
Aurora Presbyterian Hospital | Aurora, Colorado 80012 |
Boulder Community Hospital | Boulder, Colorado 80301-9019 |
Penrose Cancer Center at Penrose Hospital | Colorado Springs, Colorado 80933 |
Porter Adventist Hospital | Denver, Colorado 80210 |
Presbyterian - St. Luke's Medical Center | Denver, Colorado 80218 |
St. Joseph Hospital | Denver, Colorado 80218 |
Rose Medical Center | Denver, Colorado 80220 |
Swedish Medical Center | Englewood, Colorado 80110 |
St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center | Grand Junction, Colorado 81502 |
Sky Ridge Medical Center | Lone Tree, Colorado 80124 |
Hope Cancer Care Center at Longmont United Hospital | Longmont, Colorado 80502 |
North Suburban Medical Center | Thornton, Colorado 80229 |
Rush-Copley Cancer Care Center | Aurora, Illinois 60507 |
Evanston Northwestern Healthcare - Evanston Hospital | Evanston, Illinois 60201-1781 |
Hinsdale Hematology Oncology Associates | Hinsdale, Illinois 60521 |
Joliet Oncology-Hematology Associates, Limited - West | Joliet, Illinois 60435 |
Carle Cancer Center at Carle Foundation Hospital | Urbana, Illinois 61801 |
Saint Anthony Memorial Health Centers | Michigan City, Indiana 46360 |
Cedar Rapids Oncology Associates | Cedar Rapids, Iowa 52403 |
Mercy Medical Center - Sioux City | Sioux City, Iowa 51104 |
Siouxland Hematology-Oncology Associates, LLP | Sioux City, Iowa 51101 |
St. Luke's Regional Medical Center | Sioux City, Iowa 51104 |
CCOP - Michigan Cancer Research Consortium | Ann Arbor, Michigan 48106 |
Oakwood Cancer Center at Oakwood Hospital and Medical Center | Dearborn, Michigan 48123-2500 |
Genesys Hurley Cancer Institute | Flint, Michigan 48503 |
Van Elslander Cancer Center at St. John Hospital and Medical Center | Grosse Pointe Woods, Michigan 48236 |
Foote Hospital | Jackson, Michigan 49201 |
Bronson Methodist Hospital | Kalamazoo, Michigan 49007 |
West Michigan Cancer Center | Kalamazoo, Michigan 49007-3731 |
Borgess Medical Center | Kalamazooaa, Michigan 49001 |
Sparrow Regional Cancer Center | Lansing, Michigan 48912-1811 |
Seton Cancer Institute - Saginaw | Saginaw, Michigan 48601 |
St. John Macomb Hospital | Warren, Michigan 48093 |
Fairview Ridges Hospital | Burnsville, Minnesota 55337 |
Mercy and Unity Cancer Center at Mercy Hospital | Coon Rapids, Minnesota 55433 |
Fairview Southdale Hospital | Edina, Minnesota 55435 |
Mercy and Unity Cancer Center at Unity Hospital | Fridley, Minnesota 55432 |
Hutchinson Area Health Care | Hutchinson, Minnesota 55350 |
Meeker County Memorial Hospital | Lichfield, Minnesota 55355 |
HealthEast Cancer Care at St. John's Hospital | Maplewood, Minnesota 55109 |
Hennepin County Medical Center - Minneapolis | Minneapolis, Minnesota 55415 |
Regions Hospital Cancer Care Center | St. Paul, Minnesota 55101 |
United Hospital | St. Paul, Minnesota 55102 |
Ridgeview Medical Center | Waconia, Minnesota 55387 |
Minnesota Oncology Hematology, PA - Woodbury | Woodbury, Minnesota 55125 |
CCOP - MeritCare Hospital | Fargo, North Dakota 58122 |
Mercy Cancer Center at Mercy Medical Center | Canton, Ohio 44708 |
Case Comprehensive Cancer Center | Cleveland, Ohio 44106-5065 |
St. Rita's Medical Center | Lima, Ohio 45801 |
Natalie Warren Bryant Cancer Center at St. Francis Hospital | Tulsa, Oklahoma 74136 |
Geisinger Medical Center | Danville, Pennsylvania 17822-0001 |
Penn State Cancer Institute at Milton S. Hershey Medical Center | Hershey, Pennsylvania 17033-0850 |
Abramson Cancer Center of the University of Pennsylvania | Philadelphia, Pennsylvania 19104-4283 |
Geisinger Medical Group - Scenery Park | State College, Pennsylvania 16801 |
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center | Wilkes-Barre, Pennsylvania 18711 |
Vanderbilt-Ingram Cancer Center | Nashville, Tennessee 37232-6838 |
Marshfield Clinic - Marshfield Center | Marshfield, Wisconsin 54449 |
University of Alabama at Birmingham Comprehensive Cancer Center | Birmingham, Alabama 35294-3300 |
Memorial Hospital of South Bend | South Bend, Indiana 46601 |
Reading Hospital and Medical Center | Reading, Pennsylvania 19612-6052 |
Mercy Hospital Cancer Center - Scranton | Scranton, Pennsylvania 18501 |
CCOP - MainLine Health | Wynnewood, Pennsylvania 19096 |
University of Miami Sylvester Comprehensive Cancer Center | Miami, Florida 33136 |
Hinsdale, Illinois 60521 | |
CCOP - Northern Indiana CR Consortium | South Bend, Indiana 46601 |
Saint Joseph Regional Medical Center | South Bend, Indiana 46617 |
Siteman Cancer Center at Barnes-Jewish Hospital | Saint Louis, Missouri 63110 |
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore, Maryland 21231-2410 |
John Stoddard Cancer Center at Iowa Methodist Medical Center | Des Moines, Iowa 50309 |
St. Vincent Mercy Medical Center | Toledo, Ohio 43608 |
CCOP - Colorado Cancer Research Program, Incorporated | Denver, Colorado 80224 |
Overlook Hospital | Summit, New Jersey 07902-0220 |
Washington Cancer Institute at Washington Hospital Center | Washington, District of Columbia 20010 |
Carol G. Simon Cancer Center at Morristown Memorial Hospital | Morristown, New Jersey 07962 |
Cancer Institute of New Jersey at Hamilton | Hamilton, New Jersey 08690 |
CCOP - Toledo Community Hospital | Toledo, Ohio 43623-3456 |
Florida Hospital Cancer Institute at Florida Hospital Orlando | Orlando, Florida 32803-1273 |
Via Christi Cancer Center at Via Christi Regional Medical Center | Wichita, Kansas 67214 |
Albert Einstein Cancer Center at Albert Einstein College of Medicine | Bronx, New York 10461 |
NYU Cancer Institute at New York University Medical Center | New York, New York 10016 |
Wake Forest University Comprehensive Cancer Center | Winston-Salem, North Carolina 27157-1096 |
Medical University of Ohio Cancer Center | Toledo, Ohio 43614 |
Toledo Hospital | Toledo, Ohio 43606 |
St. Vincent Hospital Regional Cancer Center | Green Bay, Wisconsin 54307-3508 |
Aultman Hospital Cancer Center at Aultman Health Foundation | Canton, Ohio 44710-1799 |
Green Bay Oncology, Limited - Escanaba | Escanaba, Michigan 49431 |
Hunterdon Regional Cancer Center at Hunterdon Medical Center | Flemington, New Jersey 08822 |
CCOP - Hematology-Oncology Associates of Central New York | East Syracuse, New York 13057 |
Lewistown Hospital | Lewistown, Pennsylvania 17044 |
Mount Nittany Medical Center | State College, Pennsylvania 16803 |
St. Mary's Hospital Medical Center - Green Bay | Green Bay, Wisconsin 54303 |
Green Bay Oncology, Limited at St. Mary's Hospital | Green Bay, Wisconsin 54303 |
Bay Area Cancer Care Center at Bay Area Medical Center | Marinette, Wisconsin 54143 |
Green Bay Oncology, Limited - Oconto Falls | Oconto Falls, Wisconsin 54154 |
Green Bay Oncology, Limited - Sturgeon Bay | Sturgeon Bay, Wisconsin 54235 |
Hematology Oncology Associates of the Quad Cities | Bettendorf, Iowa 52722 |
Baptist Cancer Institute - Jacksonville | Jacksonville, Florida 32207 |
Siouxland Regional Cancer Center | Sioux City, Iowa 51101-1733 |
Southwest Medical Center | Liberal, Kansas 67901 |
Wayne Memorial Hospital, Incorporated | Goldsboro, North Carolina 27534 |
New Hampshire Oncology-Hematology, PA - Hooksett | Hooksett, New Hampshire 03106 |
Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph | Saint Joseph, Michigan 49085 |
Lenoir Memorial Cancer Center | Kinston, North Carolina 28503-1678 |
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center | Washington, District of Columbia 20007 |
Swedish-American Regional Cancer Center | Rockford, Illinois 61104-2315 |
St. Barnabas Medical Center Cancer Center | Livingston, New Jersey 07039 |
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School | New Brunswick, New Jersey 08903 |
Elkhart General Hospital | Elkhart, Indiana 46515 |
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton | Marlton, New Jersey 08053 |
Fox Chase Virtua Health Cancer Program at Virtua West Jersey | Voorhees, New Jersey 08043 |
Fox Chase Cancer Center - Philadelphia | Philadelphia, Pennsylvania 19111-2497 |
Front Range Cancer Specialists | Fort Collins, Colorado 80528 |
Joan Karnell Cancer Center at Pennsylvania Hospital | Philadelphia, Pennsylvania 19107 |
Memorial Medical Center Cancer Services | Modesto, California 95355 |
St. Mary-Corwin Regional Medical Center | Pueblo, Colorado 81004 |
Ingalls Cancer Care Center at Ingalls Memorial Hospital | Harvey, Illinois 60426 |
Trinity Medical Center - East | Moline, Illinois 61265 |
Fort Wayne Medical Oncology and Hematology | Fort Wayne, Indiana 46815 |
Howard Community Hospital at Howard Regional Health System | Kokomo, Indiana 46904 |
Center for Cancer Therapy at LaPorte Hospital and Health Services | La Porte, Indiana 46350 |
Bettendorf, Iowa 52722 | |
John Stoddard Cancer Center at Iowa Lutheran Hospital | Des Moines, Iowa 50316-2301 |
Mercy Capitol Hospital | Des Moines, Iowa 50307 |
Medical Oncology and Hematology Associates at John Stoddard Cancer Center | Des Moines, Iowa 50309 |
Medical Oncology and Hematology Associates at Mercy Cancer Center | Des Moines, Iowa 50314 |
Mercy Cancer Center at Mercy Medical Center - Des Moines | Des Moines, Iowa 50314 |
Medical Oncology and Hematology Associates - West Des Moines | West Des Moines, Iowa 50266 |
Cancer Center of Kansas, PA - Dodge City | Dodge City, Kansas 67801 |
Hickman Cancer Center at Bixby Medical Center | Adrian, Michigan 49221 |
St. Joseph Mercy Cancer Center at St. Joseph Mercy Hospital | Ann Arbor, Michigan 48106-0995 |
Green Bay Oncology, Limited - Iron Mountain | Iron Mountain, Michigan 49801 |
Community Cancer Center of Monroe | Monroe, Michigan 48162 |
Mercy Memorial Hospital System | Monroe, Michigan 48162 |
MeritCare Clinic - Bemidji | Bemidji, Minnesota 56601 |
Virginia Piper Cancer Institute at Abbott-Northwestern Hospital | Minneapolis, Minnesota 55407 |
Hubert H. Humphrey Cancer Center at North Memorial Medical Center | Robbinsdale, Minnesota 55422-2900 |
Park Nicollet Health Services | St. Louis Park, Minnesota 55416 |
Immanuel Medical Center | Omaha, Nebraska 68122 |
Creighton University Medical Center | Omaha, Nebraska 68131-2197 |
Mountainside Hospital Cancer Center | Montclair, New Jersey 07042 |
Booker Cancer Center at Riverview Medical Center | Red Bank, New Jersey 07701 |
Iredell Memorial Hospital | Statesville, North Carolina 28677 |
MeritCare Medical Group | Fargo, North Dakota 58122 |
Wood County Oncology Center | Bowling Green, Ohio 43402 |
Blanchard Valley Medical Associates | Findlay, Ohio 45840 |
Fremont Memorial Hospital | Fremont, Ohio 43420 |
Kenton Oncology, Incorporated | Kenton, Ohio 43326 |
Lima Memorial Hospital | Lima, Ohio 45804 |
St. Luke's Hospital | Maumee, Ohio 43537 |
Northwest Ohio Oncology Center | Maumee, Ohio 43537 |
Toledo Clinic - Oregon | Oregon, Ohio 43616 |
St. Charles Mercy Hospital | Oregon, Ohio 43616 |
North Coast Cancer Care, Incorporated | Sandusky, Ohio 44870 |
Firelands Regional Medical Center | Sandusky, Ohio 44870 |
Mercy Hospital of Tiffin | Tiffin, Ohio 44883 |
Toledo Clinic, Incorporated - Main Clinic | Toledo, Ohio 43623 |
Fulton County Health Center | Wauseon, Ohio 43567 |
Bryn Mawr Hospital | Bryn Mawr, Pennsylvania 19010 |
St. Mary Regional Cancer Center | Langhorne, Pennsylvania 19047 |
Hematology and Oncology Associates | Scranton, Pennsylvania 18510 |
Lankenau Cancer Center at Lankenau Hospital | Wynnewood, Pennsylvania 19096 |
Baptist Regional Cancer Center at Baptist Hospital of East Tennessee | Knoxville, Tennessee 37901 |
Green Bay Oncology, Limited at St. Vincent Hospital | Green Bay, Wisconsin 54301-3526 |
DeCesaris Cancer Institute at Anne Arundel Medical Center | Annapolis, Maryland 21401 |
Morton Hospital & Medical Center | Taunton, Massachusetts 02780 |
Cancer Care Center at St. Luke's Hospital | Duluth, Minnesota 55805 |
Saint Francis Cancer Center | Shakopee, Minnesota 55379 |
St. Joseph's Hospital | St Paul, Minnesota 55102 |
Carl and Dorothy Bennett Cancer Center at Stamford Hospital | Stamford, Connecticut 06904 |
William N. Wishard Memorial Hospital | Indianapolis, Indiana 46202 |
McFarland Clinic, PC | Ames, Iowa 50010 |
Cancer Center of Kansas, PA - Chanute | Chanute, Kansas 66720 |
Cancer Center of Kansas, PA - El Dorado | El Dorado, Kansas 67042 |
Cancer Center of Kansas, PA - Kingman | Kingman, Kansas 67068 |
Cancer Center of Kansas, PA - Newton | Newton, Kansas 67114 |
Cancer Center of Kansas, PA - Parsons | Parsons, Kansas 67357 |
Cancer Center of Kansas, PA - Pratt | Pratt, Kansas 67124 |
Cancer Center of Kansas, PA - Salina | Salina, Kansas 67401 |
Cancer Center of Kansas, PA - Wellington | Wellington, Kansas 67152 |
Cancer Center of Kansas, PA - Wichita | Wichita, Kansas 67214 |
Associates in Womens Health, PA - North Review | Wichita, Kansas 67208 |
Cancer Center of Kansas, PA - Medical Arts Tower | Wichita, Kansas 67208 |
Cancer Center of Kansas, PA - Winfield | Winfield, Kansas 67156 |
Haematology-Oncology Associates of Ohio and Michigan, PC | Lambertville, Michigan 48144 |
Willmar Cancer Center at Rice Memorial Hospital | Willmar, Minnesota 56201 |
Alegant Health Cancer Center at Bergan Mercy Medical Center | Omaha, Nebraska 68124 |
Flower Hospital Cancer Center | Sylvania, Ohio 43560 |
Ministry Medical Group at Saint Mary's Hospital | Rhinelander, Wisconsin 54501 |
Methodist Cancer Center at Methodist Hospital - Omaha | Omaha, Nebraska 68114 |
Stanford Comprehensive Cancer Center at Stanford University Medical Center | Stanford, California 94305 |
Elliot Regional Cancer Center at Elliot Hospital | Manchester, New Hampshire 03103 |
Manchester Memorial Hospital | Manchester, Connecticut 06040-4188 |
Sherman Hospital | Elgin, Illinois 60120-2198 |
Oncology/Hematology Associates of Southwest Indiana at St. Mary's Cancer Center | Evansville, Indiana 47714 |
Woodwinds Health Campus | Woodbury, Minnesota 55125 |
Cancer Center of Paoli Memorial Hospital | Paoli, Pennsylvania 19301-1792 |
Minnesota Oncology Hematology, PA at Maplewood Cancer Center | Maplewood, Minnesota 55109 |
Community Hospital of the Monterey Peninsula Comprehensive Cancer Center | Monterey, California 93940 |
Arnett Cancer Care | Lafayette, Indiana 47904 |
Bendheim Cancer Center at Greenwich Hospital | Greenwich, Connecticut 06830 |
Norwalk Hospital | Norwalk, Connecticut 06856 |
York Hospital | York, Maine 03909 |
Cancer Center at Erlanger Health | Chattanooga, Tennessee 37403 |