Know Cancer

or
forgot password

Phase II Study Of Dose-Adjusted Epoch-Rituximab (EPOCH-R) Chemotherapy For Patients With Previously Untreated Aggressive CD20+ B-Cell Non-Hodgkin's Lymphoma (NHL)


Phase 2
N/A
N/A
Not Enrolling
Both
Lymphoma

Thank you

Trial Information

Phase II Study Of Dose-Adjusted Epoch-Rituximab (EPOCH-R) Chemotherapy For Patients With Previously Untreated Aggressive CD20+ B-Cell Non-Hodgkin's Lymphoma (NHL)


OBJECTIVES:

- Determine the response rate, progression-free survival, and overall survival of
patients with previously untreated aggressive CD20+ B-cell diffuse large cell or
immunoblastic large cell lymphoma treated with rituximab, doxorubicin, etoposide,
vincristine, prednisone, and cyclophosphamide.

- Determine the toxic effects of this regimen in these patients.

- Correlate tumor proliferation rate (MIB-1), bcl-2 expression, and p53 overexpression
with complete response rate, progression-free survival, and overall survival in
patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive rituximab IV on day 1; doxorubicin IV continuously, etoposide IV
continuously, and vincristine IV continuously on days 1-4; oral prednisone twice daily on
days 1-5; and cyclophosphamide IV on day 5. Patients also receive filgrastim (G-CSF)
subcutaneously beginning on day 6 and continuing until blood counts recover. Treatment
repeats every 21 days for up to 8 courses in the absence of disease progression or
unacceptable toxicity. After 4 courses, patients with complete or partial response receive 2
additional courses.

Patients are followed every 3 months for 2 years and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 25-50 patients will be accrued for this study within 1 year.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed stage II, III, or IV diffuse large cell lymphoma and WHO
variants

- CD20+ large B-cell lymphoma, including those with immunoblastic features

- CD20+ thymic B-cell lymphoma

- No evidence of indolent lymphoma

- No mantle cell lymphomas or equivocal B-cell lymphomas that express markers of
mantle cell lymphoma (e.g., cyclin D) or other subtypes

- No known lymphomatous involvement of the CNS, including the parenchyma or
leptomeninges

PATIENT CHARACTERISTICS:

Age:

- Not specified

Performance status:

- CALGB 0-2

Life expectancy:

- Not specified

Hematopoietic:

- Absolute neutrophil count at least 1,000/mm3*

- Platelet count at least 100,000/mm3* NOTE: * Unless due to lymphoma

Hepatic:

- Bilirubin no greater than 2.0 mg/dL* NOTE: * Unless due to lymphoma or Gilbert's
disease

Renal:

- Creatinine no greater than 1.5 mg/dL* NOTE: * Unless due to lymphoma

Cardiovascular:

- LVEF greater than 45%

- No ischemic heart disease

- No myocardial infarction or congestive heart failure within the past year

Other:

- HIV negative

- Not pregnant or nursing

- Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- No prior cytotoxic chemotherapy

- No other concurrent chemotherapy

Endocrine therapy:

- Prior short-course of glucocorticoids allowed

- No concurrent hormones except for non-disease-related conditions (e.g., insulin for
diabetes)

- No concurrent steroids except for adrenal failure

- No concurrent dexamethasone or other steroidal antiemetics

Radiotherapy:

- Prior limited-field radiotherapy allowed

Surgery:

- Not specified

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Response

Outcome Time Frame:

5 months

Safety Issue:

No

Principal Investigator

Wyndham H. Wilson, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

National Cancer Institute (NCI)

Authority:

United States: Federal Government

Study ID:

CDR0000069249

NCT ID:

NCT00032019

Start Date:

February 2002

Completion Date:

April 2009

Related Keywords:

  • Lymphoma
  • stage III adult diffuse large cell lymphoma
  • stage III adult immunoblastic large cell lymphoma
  • stage IV adult diffuse large cell lymphoma
  • stage IV adult immunoblastic large cell lymphoma
  • contiguous stage II adult immunoblastic large cell lymphoma
  • contiguous stage II adult diffuse large cell lymphoma
  • noncontiguous stage II adult immunoblastic large cell lymphoma
  • noncontiguous stage II adult diffuse large cell lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoma, B-Cell
  • Lymphoma, Large-Cell, Immunoblastic

Name

Location

Roswell Park Cancer Institute Buffalo, New York  14263
Memorial Sloan-Kettering Cancer Center New York, New York  10021
Walter Reed Army Medical Center Washington, District of Columbia  20307-5000
University of Chicago Cancer Research Center Chicago, Illinois  60637
University of Minnesota Cancer Center Minneapolis, Minnesota  55455
Duke Comprehensive Cancer Center Durham, North Carolina  27710
Arthur G. James Cancer Hospital - Ohio State University Columbus, Ohio  43210
CCOP - Kansas City Kansas City, Missouri  64131
CCOP - Southern Nevada Cancer Research Foundation Las Vegas, Nevada  89106
CCOP - Christiana Care Health Services Wilmington, Delaware  19899
CCOP - Mount Sinai Medical Center Miami Beach, Florida  33140
Barnes-Jewish Hospital Saint Louis, Missouri  63110
CCOP - North Shore University Hospital Manhasset, New York  11030
CCOP - Southeast Cancer Control Consortium Winston-Salem, North Carolina  27104-4241
MBCCOP - Massey Cancer Center Richmond, Virginia  23298-0037
Mount Sinai Medical Center, NY New York, New York  10029
CCOP - Illinois Oncology Research Association Peoria, Illinois  61602
Comprehensive Cancer Center at Wake Forest University Winston-Salem, North Carolina  27157-1082
Western Pennsylvania Hospital Pittsburgh, Pennsylvania  15224
Green Mountain Oncology Group Rutland, Vermont  05701
Martha Jefferson Hospital Charlottesville, Virginia  22901
CCOP - Northern Indiana CR Consortium South Bend, Indiana  46601
Holden Comprehensive Cancer Center at University of Iowa Iowa City, Iowa  52242-1002
Ellis Fischel Cancer Center at University of Missouri - Columbia Columbia, Missouri  65203
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill Chapel Hill, North Carolina  27599-7570
North Shore University Hospital Manhasset, New York  11030
Veterans Affairs Medical Center - Chicago (Westside Hospital) Chicago, Illinois  60612
Naval Medical Center - San Diego San Diego, California  92134-3202
Veterans Affairs Medical Center - San Francisco San Francisco, California  94121
Baptist Hospital East - Louisville Louisville, Kentucky  40207
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C. Syracuse, New York  13217
Oncology and Hematology Associates of Southwest Virginia, Inc. Roanoke, Virginia  24014
Veterans Affairs Medical Center - Minneapolis Minneapolis, Minnesota  55417
Veterans Affairs Medical Center - Columbia (Truman Memorial) Columbia, Missouri  65201
Veterans Affairs Medical Center - Buffalo Buffalo, New York  14215
Veterans Affairs Medical Center - Syracuse Syracuse, New York  13210
Veterans Affairs Medical Center - Durham Durham, North Carolina  27705
Rebecca and John Moores UCSD Cancer Center La Jolla, California  92093-0658
Broward General Medical Center Fort Lauderdale, Florida  33316
Florida Hospital Cancer Institute Orlando, Florida  32804
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute Boston, Massachusetts  02115
University of Massachusetts Memorial Medical Center - University Campus Worcester, Massachusetts  01655
Northeast Alabama Regional Medical Center Anniston, Alabama  36207
Veterans Affairs Medical Center - San Diego San Diego, California  92161
UCSF Comprehensive Cancer Center San Francisco, California  94115
Veterans Affairs Medical Center - Washington, DC Washington, District of Columbia  20422
Memorial Regional Hospital Comprehensive Cancer Center Hollywood, Florida  33021
Louis A. Weiss Memorial Hospital Chicago, Illinois  60640
West Suburban Center for Cancer Care River Forest, Illinois  60305
Saint Anthony Medical Center Rockford, Illinois  61108
Fort Wayne Medical Oncology and Hematology, Incorporated Fort Wayne, Indiana  46885-5099
Veterans Affairs Medical Center - Las Vegas Las Vegas, Nevada  89106
Cooper University Hospital Camden, New Jersey  08103
Elmhurst Hospital Center Elmhurst, New York  11373
Queens Cancer Center of Queens Hospital Jamaica, New York  11432
Veterans Affairs Medical Center - Asheville Asheville, North Carolina  28805
NorthEast Oncology Associates Concord, North Carolina  28025
Cape Fear Valley Health System Fayetteville, North Carolina  28302-2000
Lenoir Memorial Hospital Cancer Center Kinston, North Carolina  28503-1678
FirstHealth Moore Regional Hospital Pinehurst, North Carolina  28374
New Hanover Regional Medical Center Wilmington, North Carolina  28402-9025
Lifespan: The Miriam Hospital Providence, Rhode Island  02906
Veterans Affairs Medical Center - Dallas Dallas, Texas  75216
Virginia Oncology Associates - Norfolk Norfolk, Virginia  23502
St. Mary's Medical Center Huntington, West Virginia  25701
Hematology Oncology Associates of the Quad Cities Bettendorf, Iowa  52722
Vermont Cancer Center at University of Vermont Burlington, Vermont  05405-0075
Lombardi Cancer Center at Georgetown University Medical Center Washington, District of Columbia  20007
Greenebaum Cancer Center at University of Maryland Medical Center Baltimore, Maryland  21201
UNMC Eppley Cancer Center at the University of Nebraska Medical Center Omaha, Nebraska  68198-7680
New Hampshire Oncology-Hematology, PA - Hooksett Hooksett, New Hampshire  03106
Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph Saint Joseph, Michigan  49085
New York Weill Cornell Cancer Center at Cornell University New York, New York  10021
Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center Los Angeles, California  90048
University Hospital at State University of New York - Upstate Medical University Syracuse, New York  13210
Norris Cotton Cancer Center at Dartmouth Medical School Lebanon, New Hampshire  03756-0002
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support Bethesda, Maryland  20892-1182
Missouri Baptist Cancer Center St. Louis, Missouri  63131
Oklahoma University Medical Center at University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma  73126
Palm Beach Cancer Institute West Palm Beach, Florida  33401