Comparison of Two Combination Chemotherapy Regimens in Treating Patients With Previously Untreated Aggressive Stage II, Stage III, or Stage IV Non-Hodgkin's Lymphoma
- Conditions
- Lymphoma
- Interventions
- Registration Number
- NCT00005964
- Lead Sponsor
- Alliance for Clinical Trials in Oncology
- Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one chemotherapy drug may kill more tumor cells. It is not yet known which combination chemotherapy regimen is most effective in treating aggressive non-Hodgkin's lymphoma.
PURPOSE: Randomized phase II trial to compare the effectiveness of two combination chemotherapy regimens in treating patients who have previously untreated aggressive stage II, stage III, or stage IV non-Hodgkin's lymphoma.
- Detailed Description
OBJECTIVES: I. Determine the response rates in patients with previously untreated aggressive non-Hodgkin's lymphoma treated with doxorubicin, etoposide, vincristine, cyclophosphamide, and prednisone (EPOCH). II. Determine the toxic effects of this regimen in these patients.
OUTLINE: This is a multicenter study. Patients receive doxorubicin IV, etoposide IV, vincristine IV, and cyclophosphamide IV continuously over days 1-4. Patients also receive oral prednisone twice daily on days 1-5 and filgrastim (G-CSF) subcutaneously beginning on day 6 until blood counts recover. Treatment continues every 21 days for a maximum of 8 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 2 years and then every 6 months for 3 years.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 59
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Chemotherapy + prednisone + filgrastim vincristine sulfate Patients receive doxorubicin IV, etoposide IV, vincristine IV, and cyclophosphamide IV continuously over days 1-4. Patients also receive oral prednisone twice daily on days 1-5 and filgrastim (G-CSF) subcutaneously beginning on day 6 until blood counts recover. Treatment continues every 21 days for a maximum of 8 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 2 years and then every 6 months for 3 years. Chemotherapy + prednisone + filgrastim filgrastim Patients receive doxorubicin IV, etoposide IV, vincristine IV, and cyclophosphamide IV continuously over days 1-4. Patients also receive oral prednisone twice daily on days 1-5 and filgrastim (G-CSF) subcutaneously beginning on day 6 until blood counts recover. Treatment continues every 21 days for a maximum of 8 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 2 years and then every 6 months for 3 years. Chemotherapy + prednisone + filgrastim cyclophosphamide Patients receive doxorubicin IV, etoposide IV, vincristine IV, and cyclophosphamide IV continuously over days 1-4. Patients also receive oral prednisone twice daily on days 1-5 and filgrastim (G-CSF) subcutaneously beginning on day 6 until blood counts recover. Treatment continues every 21 days for a maximum of 8 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 2 years and then every 6 months for 3 years. Chemotherapy + prednisone + filgrastim etoposide Patients receive doxorubicin IV, etoposide IV, vincristine IV, and cyclophosphamide IV continuously over days 1-4. Patients also receive oral prednisone twice daily on days 1-5 and filgrastim (G-CSF) subcutaneously beginning on day 6 until blood counts recover. Treatment continues every 21 days for a maximum of 8 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 2 years and then every 6 months for 3 years. Chemotherapy + prednisone + filgrastim prednisone Patients receive doxorubicin IV, etoposide IV, vincristine IV, and cyclophosphamide IV continuously over days 1-4. Patients also receive oral prednisone twice daily on days 1-5 and filgrastim (G-CSF) subcutaneously beginning on day 6 until blood counts recover. Treatment continues every 21 days for a maximum of 8 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 2 years and then every 6 months for 3 years. Chemotherapy + prednisone + filgrastim doxorubicin hydrochloride Patients receive doxorubicin IV, etoposide IV, vincristine IV, and cyclophosphamide IV continuously over days 1-4. Patients also receive oral prednisone twice daily on days 1-5 and filgrastim (G-CSF) subcutaneously beginning on day 6 until blood counts recover. Treatment continues every 21 days for a maximum of 8 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 2 years and then every 6 months for 3 years.
- Primary Outcome Measures
Name Time Method Response rate Up to 5 years
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (47)
Veterans Affairs Medical Center - Columbia (Truman Memorial)
🇺🇸Columbia, Missouri, United States
Ellis Fischel Cancer Center - Columbia
🇺🇸Columbia, Missouri, United States
State University of New York - Upstate Medical University
🇺🇸Syracuse, New York, United States
Veterans Affairs Medical Center - Syracuse
🇺🇸Syracuse, New York, United States
Walter Reed Army Medical Center
🇺🇸Washington, District of Columbia, United States
Barnes-Jewish Hospital
🇺🇸Saint Louis, Missouri, United States
Holden Comprehensive Cancer Center at The University of Iowa
🇺🇸Iowa City, Iowa, United States
Veterans Affairs Medical Center - Chicago (Westside Hospital)
🇺🇸Chicago, Illinois, United States
Veterans Affairs Medical Center - Togus
🇺🇸Togus, Maine, United States
CCOP - Southeast Cancer Control Consortium
🇺🇸Winston-Salem, North Carolina, United States
University of California San Diego Cancer Center
🇺🇸La Jolla, California, United States
Lombardi Cancer Center
🇺🇸Washington, District of Columbia, United States
CCOP - Christiana Care Health Services
🇺🇸Wilmington, Delaware, United States
CCOP - Mount Sinai Medical Center
🇺🇸Miami Beach, Florida, United States
University of Chicago Cancer Research Center
🇺🇸Chicago, Illinois, United States
Dana-Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Marlene & Stewart Greenebaum Cancer Center, University of Maryland
🇺🇸Baltimore, Maryland, United States
University of Massachusetts Memorial Medical Center
🇺🇸Worcester, Massachusetts, United States
CCOP - Southern Nevada Cancer Research Foundation
🇺🇸Las Vegas, Nevada, United States
Veterans Affairs Medical Center - Buffalo
🇺🇸Buffalo, New York, United States
Norris Cotton Cancer Center
🇺🇸Lebanon, New Hampshire, United States
Roswell Park Cancer Institute
🇺🇸Buffalo, New York, United States
CCOP - North Shore University Hospital
🇺🇸Manhasset, New York, United States
Memorial Sloan-Kettering Cancer Center
🇺🇸New York, New York, United States
New York Presbyterian Hospital - Cornell Campus
🇺🇸New York, New York, United States
Mount Sinai Medical Center, NY
🇺🇸New York, New York, United States
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
🇺🇸Syracuse, New York, United States
Lineberger Comprehensive Cancer Center, UNC
🇺🇸Chapel Hill, North Carolina, United States
Comprehensive Cancer Center at Wake Forest University
🇺🇸Winston-Salem, North Carolina, United States
Arthur G. James Cancer Hospital - Ohio State University
🇺🇸Columbus, Ohio, United States
Veterans Affairs Medical Center - Memphis
🇺🇸Memphis, Tennessee, United States
University of Tennessee, Memphis Cancer Center
🇺🇸Memphis, Tennessee, United States
CCOP - Southwestern Vermont Regional Cancer Center
🇺🇸Bennington, Vermont, United States
Vermont Cancer Center
🇺🇸Burlington, Vermont, United States
Veterans Affairs Medical Center - White River Junction
🇺🇸White River Junction, Vermont, United States
Veterans Affairs Medical Center - Richmond
🇺🇸Richmond, Virginia, United States
MBCCOP - Massey Cancer Center
🇺🇸Richmond, Virginia, United States
North Shore University Hospital
🇺🇸Manhasset, New York, United States
Veterans Affairs Medical Center - Birmingham
🇺🇸Birmingham, Alabama, United States
Veterans Affairs Medical Center - San Francisco
🇺🇸San Francisco, California, United States
UCSF Cancer Center and Cancer Research Institute
🇺🇸San Francisco, California, United States
Veterans Affairs Medical Center - Minneapolis
🇺🇸Minneapolis, Minnesota, United States
University of Minnesota Cancer Center
🇺🇸Minneapolis, Minnesota, United States
University of Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
Veterans Affairs Medical Center - Durham
🇺🇸Durham, North Carolina, United States
Duke Comprehensive Cancer Center
🇺🇸Durham, North Carolina, United States
Rhode Island Hospital
🇺🇸Providence, Rhode Island, United States