Phase II Trial of Standard Dose Cyclophosphamide, Doxorubicin, Vincristine, Prednisone (CHOP) and Rituximab Plus Bevacizumab for Advanced Stage Diffuse Large B-Cell NHL
OBJECTIVES:
Primary
- Determine the 1-year progression-free survival rate in patients with bulky stage II or
stage III or IV diffuse large B-cell lymphoma treated with cyclophosphamide,
doxorubicin, vincristine, prednisone (CHOP) and rituximab in combination with
bevacizumab.
Secondary
- Determine the response rate (complete response, complete unconfirmed response, and
partial response) and 2-year progression-free survival of patients treated with this
regimen.
- Determine the toxic effects of this regimen in these patients.
- Correlate angiogenic biomarkers with outcome in patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients receive rituximab IV, bevacizumab IV over 30-90 minutes, cyclophosphamide IV over
15 minutes, doxorubicin IV, and vincristine IV on day 1. Patients also receive oral
prednisone on days 1-5. Treatment repeats every 21 days for 8 courses in the absence of
disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed at least every 6 months for 2
years and then annually for 3 years.
PROJECTED ACCRUAL: A total of 70 patients will be accrued for this study within 18 months.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression-free Survival at 1 Year
Measured from time of registration to date of of first observation of progression/relapse, or death due to any cause, or last contact date
0-1 year
No
Alison T. Stopeck, MD
Study Chair
University of Arizona
United States: Food and Drug Administration
NCI-2012-03062
NCT00121199
June 2005
Name | Location |
---|---|
Fred Hutchinson Cancer Research Center | Seattle, Washington 98109 |
Tripler Army Medical Center | Honolulu, Hawaii 96859-5000 |
CCOP - Wichita | Wichita, Kansas 67214-3882 |
Medical City Dallas Hospital | Dallas, Texas 75230 |
CCOP - Atlanta Regional | Atlanta, Georgia 30342-1701 |
Providence Saint Joseph Medical Center - Burbank | Burbank, California 91505 |
CCOP - Cancer Research for the Ozarks | Springfield, Missouri 65807 |
CCOP - Montana Cancer Consortium | Billings, Montana 59101 |
CCOP - Columbus | Columbus, Ohio 43206 |
LDS Hospital | Salt Lake City, Utah 84143 |
CCOP - Grand Rapids | Grand Rapids, Michigan 49503 |
Charles M. Barrett Cancer Center at University Hospital | Cincinnati, Ohio 45267-0526 |
CCOP - Columbia River Oncology Program | Portland, Oregon 97225 |
Veterans Affairs Medical Center - Denver | Denver, Colorado 80220 |
Brooke Army Medical Center | Fort Sam Houston, Texas 78234-6200 |
Veterans Affairs Medical Center - Houston | Houston, Texas 77030 |
Utah Valley Regional Medical Center - Provo | Provo, Utah 84604 |
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences | Little Rock, Arkansas 72205 |
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus | Seattle, Washington 98104 |
Blumenthal Cancer Center at Carolinas Medical Center | Charlotte, North Carolina 28232-2861 |
Northside Hospital Cancer Center | Atlanta, Georgia 30342-1611 |
Hulston Cancer Center at Cox Medical Center South | Springfield, Missouri 65807 |
St. John's Regional Health Center | Springfield, Missouri 65804 |
Wilford Hall Medical Center | Lackland Air Force Base, Texas 78236-5300 |
Sacred Heart Cancer Center at Sacred Heart Hospital | Pensacola, Florida 32504 |
Via Christi Cancer Center at Via Christi Regional Medical Center | Wichita, Kansas 67214 |
Breslin Cancer Center at Ingham Regional Medical Center | Lansing, Michigan 48910 |
Mission Hospitals - Memorial Campus | Asheville, North Carolina 28801 |
Baylor University Medical Center - Houston | Houston, Texas 77030-2399 |
Alaska Regional Hospital Cancer Center | Anchorage, Alaska 99508 |
Southwest Medical Center | Liberal, Kansas 67901 |
Battle Creek Health System Cancer Care Center | Battle Creek, Michigan 49017 |
Holland Community Hospital | Holland, Michigan 49423 |
Hackley Hospital | Muskegon, Michigan 49443 |
Munson Medical Center | Traverse City, Michigan 49684 |
Northern Rockies Radiation Oncology Center | Billings, Montana 59101 |
Hematology-Oncology Centers of the Northern Rockies - Billings | Billings, Montana 59101 |
St. Peter's Hospital | Helena, Montana 59601 |
Kalispell Regional Medical Center | Kalispell, Montana 59901 |
Glacier Oncology, PLLC | Kalispell, Montana 59901 |
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center | Missoula, Montana 59802 |
Montana Cancer Specialists at Montana Cancer Center | Missoula, Montana 59802 |
Community Medical Center | Missoula, Montana 59801 |
Wayne Memorial Hospital, Incorporated | Goldsboro, North Carolina 27534 |
Adena Regional Medical Center | Chillicothe, Ohio 54601 |
Doctors Hospital at Ohio Health | Columbus, Ohio 43228 |
Riverside Methodist Hospital Cancer Care | Columbus, Ohio 43214 |
Grady Memorial Hospital | Delaware, Ohio 43015 |
Fairfield Medical Center | Lancaster, Ohio 43130 |
Strecker Cancer Center at Marietta Memorial Hospital | Marietta, Ohio 45750 |
Licking Memorial Cancer Care Program at Licking Memorial Hospital | Newark, Ohio 43055 |
Community Hospital of Springfield and Clark County | Springfield, Ohio 45505 |
Genesis - Good Samaritan Hospital | Zanesville, Ohio 43701 |
American Fork Hospital | American Fork, Utah 84003 |
Logan Regional Hospital | Logan, Utah 84321 |
Utah Cancer Specialists at UCS Cancer Center | Salt Lake City, Utah 84106 |
Olympic Hematology and Oncology | Bremerton, Washington 98310 |
University Cancer Center at University of Washington Medical Center | Seattle, Washington 98195 |
Harborview Medical Center | Seattle, Washington 98104 |
Group Health Central Hospital | Seattle, Washington 98104 |
Cancer Care Northwest - Spokane South | Spokane, Washington 99202 |
Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center | Savannah, Georgia 31403-3089 |
Mountain States Tumor Institute at St. Luke's Regional Medical Center | Boise, Idaho 83712-6297 |
Butterworth Hospital at Spectrum Health | Grand Rapids, Michigan 49503-2560 |
Legacy Emanuel Hospital and Health Center and Children's Hospital | Portland, Oregon 97227 |
Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center | Orange, California 92868 |
Huntsman Cancer Institute at University of Utah | Salt Lake City, Utah 84112 |
Decatur Memorial Hospital Cancer Care Institute | Decatur, Illinois 62526 |
Mount Carmel Health - West Hospital | Columbus, Ohio 43222 |
Poudre Valley Hospital | Fort Collins, Colorado 80524 |
Saint Joseph's Hospital of Atlanta | Atlanta, Georgia 30342-1701 |
Piedmont Hospital | Atlanta, Georgia 30309 |
WellStar Cobb Hospital | Austell, Georgia 30106 |
Charles B. Eberhart Cancer Center at DeKalb Medical Center | Decatur, Georgia 30033 |
Gwinnett Medical Center | Lawrenceville, Georgia 30045 |
Kennestone Cancer Center at Wellstar Kennestone Hospital | Marietta, Georgia 30060 |
Southern Regional Medical Center | Riverdale, Georgia 30274-2600 |
Edward Hospital Cancer Center | Naperville, Illinois 60540 |
Hematology Oncology Consultants - Naperville | Naperville, Illinois 60540 |
Genesis Medical Center - West Campus | Davenport, Iowa 52804 |
Genesis Regional Cancer Center at Genesis Medical Center | Davenport, Iowa 52803 |
Cancer Center of Kansas, PA - Dodge City | Dodge City, Kansas 67801 |
Louisiana State University Health Sciences Center - Monroe | Monroe, Louisiana 71210 |
Feist-Weiller Cancer Center at Louisiana State University Health Sciences | Shreveport, Louisiana 71130-3932 |
Bay Regional Medical Center | Bay City, Michigan 48708 |
Mecosta County Medical Center | Big Rapids, Michigan 49307 |
Providence Cancer Institute at Providence Hospital - Southfield Campus | Southfield, Michigan 48075 |
Adirondack Cancer Care - Glens Falls | Glens Falls, New York 12801 |
Mercy Medical Center | Springfield, Ohio 45504 |
Legacy Mount Hood Medical Center | Gresham, Oregon 97030 |
Providence Milwaukie Hospital | Milwaukie, Oregon 97222 |
Providence Cancer Center at Providence Portland Medical Center | Portland, Oregon 97213-2967 |
Providence St. Vincent Medical Center | Portland, Oregon 97225 |
Legacy Meridian Park Hospital | Tualatin, Oregon 97062 |
Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center | Kingsport, Tennessee 37662 |
Dixie Regional Medical Center - East Campus | Saint George, Utah 84770 |
Danville Regional Medical Center | Danville, Virginia 24541 |
Minor and James Medical, PLLC | Seattle, Washington 98104 |
Polyclinic First Hill | Seattle, Washington 98122 |
Southwest Washington Medical Center Cancer Center | Vancouver, Washington 98668 |
North Star Lodge Cancer Center at Yakima Valley Memorial Hospital | Yakima, Washington 98902 |
Welch Cancer Center at Sheridan Memorial Hospital | Sheridan, Wyoming 82801 |
Montrose Memorial Hospital Cancer Center | Montrose, Colorado 81401 |
Exempla Lutheran Medical Center | Wheat Ridge, Colorado 80033 |
West Florida Cancer Institute at West Florida Hospital - Pensacola | Pensacola, Florida 32514 |
Cancer Center of Kansas, PA - Chanute | Chanute, Kansas 66720 |
Cancer Center of Kansas, PA - El Dorado | El Dorado, Kansas 67042 |
Cancer Center of Kansas-Independence | Independence, Kansas 67301 |
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 |
Tammy Walker Cancer Center at Salina Regional Health Center | Salina, Kansas 67401 |
Cancer Center of Kansas, PA - Salina | Salina, Kansas 67401 |
Cotton-O'Neil Cancer Center | Topeka, Kansas 66606 |
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 |
Billings Clinic - Downtown | Billings, Montana 59107-7000 |
Bozeman Deaconess Cancer Center | Bozeman, Montana 59715 |
St. James Healthcare Cancer Care | Butte, Montana 59701 |
Great Falls Clinic - Main Facility | Great Falls, Montana 59405 |
Northern Montana Hospital | Havre, Montana 59501 |
Kalispell Medical Oncology at KRMC | Kalispell, Montana 59901 |
Mary Rutan Hospital | Bellefontaine, Ohio 43311 |
Grant Medical Center Cancer Care | Columbus, Ohio 43215 |
Mount Carmel St. Ann's Cancer Center | Westerville, Ohio 43081 |
Adventist Medical Center | Portland, Oregon 97216 |
Legacy Good Samaritan Hospital & Comprehensive Cancer Center | Portland, Oregon 97210 |
Sandra L. Maxwell Cancer Center | Cedar City, Utah 84720 |
Jon and Karen Huntsman Cancer Center at Intermountain Medical Center | Murray, Utah 84157 |
Val and Ann Browning Cancer Center at McKay-Dee Hospital Center | Ogden, Utah 84403 |
Southwest Virginia Regional Cancer Center at Wellmonth Health | Norton, Virginia 24273 |
St. Joseph Cancer Center | Bellingham, Washington 98225 |
Columbia Basin Hematology | Kennewick, Washington 99336 |
Community Comprehensive Cancer Center at Camden-Clark Memorial Hospital | Parkersburg, West Virginia 26102 |
Regional Cancer Center at Memorial Medical Center | Springfield, Illinois 62781-0001 |
Ben Taub General Hospital | Houston, Texas 77030 |
Methodist Hospital | Houston, Texas 77030 |
Tucker Center for Cancer Care at Orange Regional Medical Center | Middletown, New York 10940-4199 |
Pardee Memorial Hospital | Hendersonville, North Carolina 28791 |
Three Rivers Community Hospital | Grants Pass, Oregon 97527 |
Dubs Cancer Center at Rogue Valley Medical Center | Medford, Oregon 97504 |
Sherman Hospital | Elgin, Illinois 60120-2198 |
Providence Cancer Center | Anchorage, Alaska 99508 |
Lacks Cancer Center at Saint Mary's Health Care | Grand Rapids, Michigan 49503 |
Metro Health Hospital | Grand Rapids, Michigan 49506 |
Great Falls, Montana 59405 | |
Guardian Oncology and Center for Wellness | Missoula, Montana 59804 |
St. Vincent Healthcare Cancer Care Services | Billings, Montana 59101 |
University of Colorado Cancer Center at UC Health Sciences Center | Aurora, Colorado 80045 |
Providence Cancer Center at PMCC | Medford, Oregon 97504 |
Christus Schumpert Cancer Treatment Center | Shreveport, Louisiana 71101 |
CaroMont Cancer Center at Gaston Memorial Hospital | Gastonia, North Carolina 28053 |
Ben E. Owens Cancer Treatment Center at St. Bernard's Medical Center | Jonesboro, Arkansas 72401-9320 |
St. Luke's Texas Cancer Institute at St. Luke's Episcopal Hospital | Houston, Texas 77030 |
Shaw Regional Cancer Center | Edwards, Colorado 81632 |