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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 CenterSeattle, Washington  98109
Tripler Army Medical CenterHonolulu, Hawaii  96859-5000
CCOP - WichitaWichita, Kansas  67214-3882
Medical City Dallas HospitalDallas, Texas  75230
CCOP - Atlanta RegionalAtlanta, Georgia  30342-1701
Providence Saint Joseph Medical Center - BurbankBurbank, California  91505
CCOP - Cancer Research for the OzarksSpringfield, Missouri  65807
CCOP - Montana Cancer ConsortiumBillings, Montana  59101
CCOP - ColumbusColumbus, Ohio  43206
LDS HospitalSalt Lake City, Utah  84143
CCOP - Grand RapidsGrand Rapids, Michigan  49503
Charles M. Barrett Cancer Center at University HospitalCincinnati, Ohio  45267-0526
CCOP - Columbia River Oncology ProgramPortland, Oregon  97225
Veterans Affairs Medical Center - DenverDenver, Colorado  80220
Brooke Army Medical CenterFort Sam Houston, Texas  78234-6200
Veterans Affairs Medical Center - HoustonHouston, Texas  77030
Utah Valley Regional Medical Center - ProvoProvo, Utah  84604
Arkansas Cancer Research Center at University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
Swedish Cancer Institute at Swedish Medical Center - First Hill CampusSeattle, Washington  98104
Blumenthal Cancer Center at Carolinas Medical CenterCharlotte, North Carolina  28232-2861
Northside Hospital Cancer CenterAtlanta, Georgia  30342-1611
Hulston Cancer Center at Cox Medical Center SouthSpringfield, Missouri  65807
St. John's Regional Health CenterSpringfield, Missouri  65804
Wilford Hall Medical CenterLackland Air Force Base, Texas  78236-5300
Sacred Heart Cancer Center at Sacred Heart HospitalPensacola, Florida  32504
Via Christi Cancer Center at Via Christi Regional Medical CenterWichita, Kansas  67214
Breslin Cancer Center at Ingham Regional Medical CenterLansing, Michigan  48910
Mission Hospitals - Memorial CampusAsheville, North Carolina  28801
Baylor University Medical Center - HoustonHouston, Texas  77030-2399
Alaska Regional Hospital Cancer CenterAnchorage, Alaska  99508
Southwest Medical CenterLiberal, Kansas  67901
Battle Creek Health System Cancer Care CenterBattle Creek, Michigan  49017
Holland Community HospitalHolland, Michigan  49423
Hackley HospitalMuskegon, Michigan  49443
Munson Medical CenterTraverse City, Michigan  49684
Northern Rockies Radiation Oncology CenterBillings, Montana  59101
Hematology-Oncology Centers of the Northern Rockies - BillingsBillings, Montana  59101
St. Peter's HospitalHelena, Montana  59601
Kalispell Regional Medical CenterKalispell, Montana  59901
Glacier Oncology, PLLCKalispell, Montana  59901
Montana Cancer Center at St. Patrick Hospital and Health Sciences CenterMissoula, Montana  59802
Montana Cancer Specialists at Montana Cancer CenterMissoula, Montana  59802
Community Medical CenterMissoula, Montana  59801
Wayne Memorial Hospital, IncorporatedGoldsboro, North Carolina  27534
Adena Regional Medical CenterChillicothe, Ohio  54601
Doctors Hospital at Ohio HealthColumbus, Ohio  43228
Riverside Methodist Hospital Cancer CareColumbus, Ohio  43214
Grady Memorial HospitalDelaware, Ohio  43015
Fairfield Medical CenterLancaster, Ohio  43130
Strecker Cancer Center at Marietta Memorial HospitalMarietta, Ohio  45750
Licking Memorial Cancer Care Program at Licking Memorial HospitalNewark, Ohio  43055
Community Hospital of Springfield and Clark CountySpringfield, Ohio  45505
Genesis - Good Samaritan HospitalZanesville, Ohio  43701
American Fork HospitalAmerican Fork, Utah  84003
Logan Regional HospitalLogan, Utah  84321
Utah Cancer Specialists at UCS Cancer CenterSalt Lake City, Utah  84106
Olympic Hematology and OncologyBremerton, Washington  98310
University Cancer Center at University of Washington Medical CenterSeattle, Washington  98195
Harborview Medical CenterSeattle, Washington  98104
Group Health Central HospitalSeattle, Washington  98104
Cancer Care Northwest - Spokane SouthSpokane, Washington  99202
Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical CenterSavannah, Georgia  31403-3089
Mountain States Tumor Institute at St. Luke's Regional Medical CenterBoise, Idaho  83712-6297
Butterworth Hospital at Spectrum HealthGrand Rapids, Michigan  49503-2560
Legacy Emanuel Hospital and Health Center and Children's HospitalPortland, Oregon  97227
Chao Family Comprehensive Cancer Center at University of California Irvine Medical CenterOrange, California  92868
Huntsman Cancer Institute at University of UtahSalt Lake City, Utah  84112
Decatur Memorial Hospital Cancer Care InstituteDecatur, Illinois  62526
Mount Carmel Health - West HospitalColumbus, Ohio  43222
Poudre Valley HospitalFort Collins, Colorado  80524
Saint Joseph's Hospital of AtlantaAtlanta, Georgia  30342-1701
Piedmont HospitalAtlanta, Georgia  30309
WellStar Cobb HospitalAustell, Georgia  30106
Charles B. Eberhart Cancer Center at DeKalb Medical CenterDecatur, Georgia  30033
Gwinnett Medical CenterLawrenceville, Georgia  30045
Kennestone Cancer Center at Wellstar Kennestone HospitalMarietta, Georgia  30060
Southern Regional Medical CenterRiverdale, Georgia  30274-2600
Edward Hospital Cancer CenterNaperville, Illinois  60540
Hematology Oncology Consultants - NapervilleNaperville, Illinois  60540
Genesis Medical Center - West CampusDavenport, Iowa  52804
Genesis Regional Cancer Center at Genesis Medical CenterDavenport, Iowa  52803
Cancer Center of Kansas, PA - Dodge CityDodge City, Kansas  67801
Louisiana State University Health Sciences Center - MonroeMonroe, Louisiana  71210
Feist-Weiller Cancer Center at Louisiana State University Health SciencesShreveport, Louisiana  71130-3932
Bay Regional Medical CenterBay City, Michigan  48708
Mecosta County Medical CenterBig Rapids, Michigan  49307
Providence Cancer Institute at Providence Hospital - Southfield CampusSouthfield, Michigan  48075
Adirondack Cancer Care - Glens FallsGlens Falls, New York  12801
Mercy Medical CenterSpringfield, Ohio  45504
Legacy Mount Hood Medical CenterGresham, Oregon  97030
Providence Milwaukie HospitalMilwaukie, Oregon  97222
Providence Cancer Center at Providence Portland Medical CenterPortland, Oregon  97213-2967
Providence St. Vincent Medical CenterPortland, Oregon  97225
Legacy Meridian Park HospitalTualatin, Oregon  97062
Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical CenterKingsport, Tennessee  37662
Dixie Regional Medical Center - East CampusSaint George, Utah  84770
Danville Regional Medical CenterDanville, Virginia  24541
Minor and James Medical, PLLCSeattle, Washington  98104
Polyclinic First HillSeattle, Washington  98122
Southwest Washington Medical Center Cancer CenterVancouver, Washington  98668
North Star Lodge Cancer Center at Yakima Valley Memorial HospitalYakima, Washington  98902
Welch Cancer Center at Sheridan Memorial HospitalSheridan, Wyoming  82801
Montrose Memorial Hospital Cancer CenterMontrose, Colorado  81401
Exempla Lutheran Medical CenterWheat Ridge, Colorado  80033
West Florida Cancer Institute at West Florida Hospital - PensacolaPensacola, Florida  32514
Cancer Center of Kansas, PA - ChanuteChanute, Kansas  66720
Cancer Center of Kansas, PA - El DoradoEl Dorado, Kansas  67042
Cancer Center of Kansas-IndependenceIndependence, Kansas  67301
Cancer Center of Kansas, PA - KingmanKingman, Kansas  67068
Cancer Center of Kansas, PA - NewtonNewton, Kansas  67114
Cancer Center of Kansas, PA - ParsonsParsons, Kansas  67357
Cancer Center of Kansas, PA - PrattPratt, Kansas  67124
Tammy Walker Cancer Center at Salina Regional Health CenterSalina, Kansas  67401
Cancer Center of Kansas, PA - SalinaSalina, Kansas  67401
Cotton-O'Neil Cancer CenterTopeka, Kansas  66606
Cancer Center of Kansas, PA - WellingtonWellington, Kansas  67152
Cancer Center of Kansas, PA - WichitaWichita, Kansas  67214
Associates in Womens Health, PA - North ReviewWichita, Kansas  67208
Cancer Center of Kansas, PA - Medical Arts TowerWichita, Kansas  67208
Cancer Center of Kansas, PA - WinfieldWinfield, Kansas  67156
Billings Clinic - DowntownBillings, Montana  59107-7000
Bozeman Deaconess Cancer CenterBozeman, Montana  59715
St. James Healthcare Cancer CareButte, Montana  59701
Great Falls Clinic - Main FacilityGreat Falls, Montana  59405
Northern Montana HospitalHavre, Montana  59501
Kalispell Medical Oncology at KRMCKalispell, Montana  59901
Mary Rutan HospitalBellefontaine, Ohio  43311
Grant Medical Center Cancer CareColumbus, Ohio  43215
Mount Carmel St. Ann's Cancer CenterWesterville, Ohio  43081
Adventist Medical CenterPortland, Oregon  97216
Legacy Good Samaritan Hospital & Comprehensive Cancer CenterPortland, Oregon  97210
Sandra L. Maxwell Cancer CenterCedar City, Utah  84720
Jon and Karen Huntsman Cancer Center at Intermountain Medical CenterMurray, Utah  84157
Val and Ann Browning Cancer Center at McKay-Dee Hospital CenterOgden, Utah  84403
Southwest Virginia Regional Cancer Center at Wellmonth HealthNorton, Virginia  24273
St. Joseph Cancer CenterBellingham, Washington  98225
Columbia Basin HematologyKennewick, Washington  99336
Community Comprehensive Cancer Center at Camden-Clark Memorial HospitalParkersburg, West Virginia  26102
Regional Cancer Center at Memorial Medical CenterSpringfield, Illinois  62781-0001
Ben Taub General HospitalHouston, Texas  77030
Methodist HospitalHouston, Texas  77030
Tucker Center for Cancer Care at Orange Regional Medical CenterMiddletown, New York  10940-4199
Pardee Memorial HospitalHendersonville, North Carolina  28791
Three Rivers Community HospitalGrants Pass, Oregon  97527
Dubs Cancer Center at Rogue Valley Medical CenterMedford, Oregon  97504
Sherman HospitalElgin, Illinois  60120-2198
Providence Cancer CenterAnchorage, Alaska  99508
Lacks Cancer Center at Saint Mary's Health CareGrand Rapids, Michigan  49503
Metro Health HospitalGrand Rapids, Michigan  49506
Great Falls, Montana  59405
Guardian Oncology and Center for WellnessMissoula, Montana  59804
St. Vincent Healthcare Cancer Care ServicesBillings, Montana  59101
University of Colorado Cancer Center at UC Health Sciences CenterAurora, Colorado  80045
Providence Cancer Center at PMCCMedford, Oregon  97504
Christus Schumpert Cancer Treatment CenterShreveport, Louisiana  71101
CaroMont Cancer Center at Gaston Memorial HospitalGastonia, North Carolina  28053
Ben E. Owens Cancer Treatment Center at St. Bernard's Medical CenterJonesboro, Arkansas  72401-9320
St. Luke's Texas Cancer Institute at St. Luke's Episcopal HospitalHouston, Texas  77030
Shaw Regional Cancer CenterEdwards, Colorado  81632