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Sponsors and Collaborators: |
Cancer and Leukemia Group B National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00032019 |
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies such as rituximab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining rituximab with combination chemotherapy may kill more cancer cells.
PURPOSE: Phase II trial to study the effectiveness of combining rituximab with combination chemotherapy in treating patients who have previously untreated non-Hodgkin's lymphoma.
Condition | Intervention | Phase |
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Lymphoma |
Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: etoposide Drug: filgrastim Drug: prednisone Drug: rituximab Drug: vincristine sulfate |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | 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) |
Study Start Date: | February 2002 |
OBJECTIVES:
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.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed stage II, III, or IV diffuse large cell lymphoma and WHO variants
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Study Chair: | Wyndham H. Wilson, MD, PhD | National Cancer Institute (NCI) |
Study ID Numbers: | CDR0000069249, CALGB-50103 |
Study First Received: | March 8, 2002 |
Last Updated: | December 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00032019 |
Health Authority: | United States: Federal Government |
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 |
Prednisone Lymphoma, Large B-Cell, Diffuse Immunoproliferative Disorders Rituximab Lymphoma, small cleaved-cell, diffuse Vincristine Cyclophosphamide Etoposide phosphate Doxorubicin Lymphoma, large-cell, immunoblastic Antibodies, Monoclonal Lymphoma, B-Cell |
Lymphoma, large-cell Lymphatic Diseases Antibodies B-cell lymphomas Lymphoma, Large-Cell, Immunoblastic Lymphoma, Non-Hodgkin Aggression Lymphoproliferative Disorders Etoposide Lymphoma Immunoglobulins |
Anti-Inflammatory Agents Neoplasms by Histologic Type Antineoplastic Agents, Hormonal Immune System Diseases Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Mitosis Modulators Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Antimitotic Agents Antibiotics, Antineoplastic |
Hormones Glucocorticoids Immunosuppressive Agents Pharmacologic Actions Neoplasms Therapeutic Uses Tubulin Modulators Myeloablative Agonists Antineoplastic Agents, Alkylating Antirheumatic Agents Antineoplastic Agents, Phytogenic Alkylating Agents |