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Phase II Trial of Standard Dose Cyclophosphamide, Doxorubicin, Vincristine, Prednisone (CHOP) and Rituximab Plus Bevacizumab for Advanced Stage Diffuse Large B-Cell NHL


Phase 2
18 Years
N/A
Not Enrolling
Both
Lymphoma

Thank you

Trial Information

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.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed* diffuse large B-cell lymphoma, meeting 1 of the following
stage criteria:

- Bulky stage II

- Stage III

- Stage IV NOTE: *Adequate sections from the original diagnostic specimen must be
available; needle aspiration or cytology are not considered adequate

- Bidimensionally measurable disease

- CD20-positive disease

- No prior indolent lymphoma, including histologic transformation or mixed histology
with an indolent or nodular component

- No clinical evidence of CNS involvement by lymphoma

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- Zubrod 0-2

Life expectancy

- Not specified

Hematopoietic

- Absolute neutrophil count > 1,000/mm^3

- Platelet count > 100,000/mm^3

- No bleeding diathesis or coagulopathy

Hepatic

- Not specified

Renal

- Creatinine < 2 times upper limit of normal

- No proteinuria ≥ +1 by dipstick or urinalysis OR

- Urine protein:creatinine ratio < 1.0 OR

- Urine protein < 1 g by 24-hour urine collection

Cardiovascular

- No uncontrolled hypertension

- No myocardial infarction within the past 6 months

- No unstable angina within the past 6 months

- No stroke within the past 6 months

- No arterial thrombosis within the past 6 months

- No clinically significant peripheral vascular disease

- Ejection fraction ≥ 45% by MUGA or 2-dimensional echocardiogram (2-D ECHO)

- No significant cardiac abnormality by MUGA or 2-D ECHO

Pulmonary

- No requirement for continuous supplemental oxygen

Gastrointestinal

- No abdominal fistula within the past 6 months

- No gastrointestinal perforation within the past 6 months

- No intra-abdominal abscess within the past 6 months

Other

- Not pregnant or nursing

- Fertile patients must use effective contraception during and for 6 months after
completion of study therapy

- No known HIV positivity

- No history of hypersensitivity reaction to products containing polysorbate 20 (Tween
20), Chinese hamster ovary cell products, or recombinant human antibodies

- No traumatic injury within the past 28 days

- No serious or non-healing wound, ulcer, or bone fracture

- No other malignancy within the past 5 years except adequately treated basal cell or
squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated
stage I or II cancer in complete remission

PRIOR CONCURRENT THERAPY:

Biologic therapy

- No prior antibody-based therapy for lymphoma

Chemotherapy

- No prior chemotherapy for lymphoma

Endocrine therapy

- Not specified

Radiotherapy

- No prior radiotherapy for lymphoma

Surgery

- More than 28 days since prior and no concurrent major surgery

- No prior solid organ transplantation

Other

- Concurrent full-dose anticoagulants allowed for treatment of venous thrombosis
provided the following criteria are met:

- INR in range (i.e., 2-3)

- Patient is on a stable dose of warfarin or low molecular weight heparin

- No bleeding or pathological condition that would confer a high risk of bleeding
(e.g., tumor involving major vessels or known varices)

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free Survival at 1 Year

Outcome Description:

Measured from time of registration to date of of first observation of progression/relapse, or death due to any cause, or last contact date

Outcome Time Frame:

0-1 year

Safety Issue:

No

Principal Investigator

Alison T. Stopeck, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Arizona

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2012-03062

NCT ID:

NCT00121199

Start Date:

June 2005

Completion Date:

Related Keywords:

  • Lymphoma
  • stage III adult diffuse large cell lymphoma
  • stage IV adult diffuse large cell lymphoma
  • contiguous stage II adult diffuse large cell lymphoma
  • noncontiguous stage II adult diffuse large cell lymphoma
  • Lymphoma
  • Lymphoma, Large B-Cell, Diffuse

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