- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00005964
Comparison of Two Combination Chemotherapy Regimens in Treating Patients With Previously Untreated Aggressive Stage II, Stage III, or Stage IV Non-Hodgkin's Lymphoma
Randomized Phase II Study of Dose-Adjusted EPOCH vs. NHL-15 Chemotherapy for Patients With Previously Untreated Aggressive Non-Hodgkin's Lymphoma (NHL)
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.
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Alabama
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Birmingham, Alabama, United States, 35233-1996
- Veterans Affairs Medical Center - Birmingham
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California
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La Jolla, California, United States, 92093-0658
- University of California San Diego Cancer Center
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San Francisco, California, United States, 94121
- Veterans Affairs Medical Center - San Francisco
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San Francisco, California, United States, 94143-0128
- UCSF Cancer Center and Cancer Research Institute
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Delaware
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Wilmington, Delaware, United States, 19899
- CCOP - Christiana Care Health Services
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District of Columbia
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Washington, District of Columbia, United States, 20307-5000
- Walter Reed Army Medical Center
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Washington, District of Columbia, United States, 20007
- Lombardi Cancer Center
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Florida
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Miami Beach, Florida, United States, 33140
- CCOP - Mount Sinai Medical Center
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Illinois
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Chicago, Illinois, United States, 60612
- Veterans Affairs Medical Center - Chicago (Westside Hospital)
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Chicago, Illinois, United States, 60637-1470
- University of Chicago Cancer Research Center
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Iowa
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Iowa City, Iowa, United States, 52242-1009
- Holden Comprehensive Cancer Center at the University of Iowa
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Maine
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Togus, Maine, United States, 04330
- Veterans Affairs Medical Center - Togus
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Maryland
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Baltimore, Maryland, United States, 21201
- Marlene & Stewart Greenebaum Cancer Center, University of Maryland
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Massachusetts
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Boston, Massachusetts, United States, 02115
- Dana-Farber Cancer Institute
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Worcester, Massachusetts, United States, 01655
- University of Massachusetts Memorial Medical Center
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Minnesota
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Minneapolis, Minnesota, United States, 55417
- Veterans Affairs Medical Center - Minneapolis
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Minneapolis, Minnesota, United States, 55455
- University of Minnesota Cancer Center
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Missouri
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Columbia, Missouri, United States, 65201
- Veterans Affairs Medical Center - Columbia (Truman Memorial)
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Columbia, Missouri, United States, 65203
- Ellis Fischel Cancer Center - Columbia
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Saint Louis, Missouri, United States, 63110
- Barnes-Jewish Hospital
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Nebraska
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Omaha, Nebraska, United States, 68198-3330
- University of Nebraska Medical Center
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Nevada
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Las Vegas, Nevada, United States, 89106
- CCOP - Southern Nevada Cancer Research Foundation
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New Hampshire
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Lebanon, New Hampshire, United States, 03756-0002
- Norris Cotton Cancer Center
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New York
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Buffalo, New York, United States, 14263-0001
- Roswell Park Cancer Institute
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Buffalo, New York, United States, 14215
- Veterans Affairs Medical Center - Buffalo
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Manhasset, New York, United States, 11030
- CCOP - North Shore University Hospital
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Manhasset, New York, United States, 11030
- North Shore University Hospital
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New York, New York, United States, 10021
- Memorial Sloan-Kettering Cancer Center
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New York, New York, United States, 10021
- New York Presbyterian Hospital - Cornell Campus
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New York, New York, United States, 10029
- Mount Sinai Medical Center, NY
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Syracuse, New York, United States, 13210
- State University of New York - Upstate Medical University
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Syracuse, New York, United States, 13210
- Veterans Affairs Medical Center - Syracuse
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Syracuse, New York, United States, 13217
- CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
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North Carolina
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Chapel Hill, North Carolina, United States, 27599-7295
- Lineberger Comprehensive Cancer Center, UNC
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Durham, North Carolina, United States, 27705
- Veterans Affairs Medical Center - Durham
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Durham, North Carolina, United States, 27710
- Duke Comprehensive Cancer Center
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Winston-Salem, North Carolina, United States, 27104-4241
- CCOP - Southeast Cancer Control Consortium
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Winston-Salem, North Carolina, United States, 27157-1082
- Comprehensive Cancer Center at Wake Forest University
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Ohio
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Columbus, Ohio, United States, 43210-1240
- Arthur G. James Cancer Hospital - Ohio State University
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Rhode Island
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Providence, Rhode Island, United States, 02903
- Rhode Island Hospital
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Tennessee
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Memphis, Tennessee, United States, 38103
- University of Tennessee, Memphis Cancer Center
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Memphis, Tennessee, United States, 38104
- Veterans Affairs Medical Center - Memphis
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Vermont
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Bennington, Vermont, United States, 05201
- CCOP - Southwestern Vermont Regional Cancer Center
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Burlington, Vermont, United States, 05401-3498
- Vermont Cancer Center
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White River Junction, Vermont, United States, 05009
- Veterans Affairs Medical Center - White River Junction
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Virginia
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Richmond, Virginia, United States, 23298-0037
- MBCCOP - Massey Cancer Center
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Richmond, Virginia, United States, 23249
- Veterans Affairs Medical Center - Richmond
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS: Histologically confirmed stage II, III, or IV non-Hodgkin's lymphoma (NHL) Diffuse large B-cell lymphoma (including immunoblastic features) OR Anaplastic large cell lymphoma No mantle cell lymphomas including equivocal B-cell lymphomas that are CD5+ and CD23-, have t(11;14), or express markers of mantle cell lymphoma or other subtypes No low-grade lymphoma (e.g., follicular center cells in bone marrow) Patients who have 3-5 International Prognostic Index risk factors must have refused participation in SWOG-S9704/CALGB-59903 trial No known lymphomatous CNS involvement, including parenchymal or leptomeningeal involvement
PATIENT CHARACTERISTICS: Age: Not specified Performance status: 0-2 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3* Platelet count at least 100,000/mm3* *unless attributable to NHL Hepatic: Bilirubin no greater than 2.0 mg/dL (without Gilbert's disease)* *unless attributable to NHL Renal: Creatinine no greater than 1.5 mg/dL* *unless attributable to NHL Cardiovascular: LVEF greater than 45% No ischemic heart disease No myocardial infarction or congestive heart failure in past year Other: Not pregnant or nursing Fertile patients must use effective contraception HIV negative
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior cytotoxic chemotherapy No other concurrent chemotherapy Endocrine therapy: Prior glucocorticoids allowed (less than 10 day course) for urgent local disease at diagnosis (e.g., cord compression, superior vena cava syndrome) No concurrent dexamethasone (except as indicated by protocol) or other steroidal antiemetics No concurrent hormonal therapy except for non-disease related conditions Radiotherapy: Prior limited field radiotherapy allowed Surgery: Not specified
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Chemotherapy + prednisone + 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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Response rate
Time Frame: Up to 5 years
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Up to 5 years
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Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Andrew Zelenetz, MD, PhD, Memorial Sloan Kettering Cancer Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- 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
- stage III adult lymphoblastic lymphoma
- stage IV adult lymphoblastic lymphoma
- noncontiguous stage II adult diffuse large cell lymphoma
- noncontiguous stage II adult lymphoblastic lymphoma
- noncontiguous stage II adult immunoblastic large cell lymphoma
- contiguous stage II adult immunoblastic large cell lymphoma
- contiguous stage II adult diffuse large cell lymphoma
- contiguous stage II adult lymphoblastic lymphoma
Additional Relevant MeSH Terms
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Lymphoma
- Lymphoma, Non-Hodgkin
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Myeloablative Agonists
- Antineoplastic Agents, Phytogenic
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Antibiotics, Antineoplastic
- Cyclophosphamide
- Etoposide
- Prednisone
- Doxorubicin
- Liposomal doxorubicin
- Vincristine
Other Study ID Numbers
- CALGB-C59910
- U10CA031946 (U.S. NIH Grant/Contract)
- CLB-C59910
- CDR0000067947 (Registry Identifier: NCI Physician Data Query)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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