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| Sponsors and Collaborators: |
Cancer and Leukemia Group B National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00005964 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Lymphoma |
Biological: filgrastim Drug: EPOCH regimen Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: etoposide Drug: prednisone Drug: vincristine sulfate |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | Randomized Phase II Study of Dose-Adjusted EPOCH vs. NHL-15 Chemotherapy for Patients With Previously Untreated Aggressive Non-Hodgkin's Lymphoma (NHL) |
| Study Start Date: | May 2000 |
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.
PROJECTED ACCRUAL: A total of 59 patients will be accrued for this study within 1 year.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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)*
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
Contacts and Locations
Show 47 Study Locations| Study Chair: | Andrew D. Zelenetz, MD, PhD | Memorial Sloan-Kettering Cancer Center |
More Information
| Study ID Numbers: | CDR0000067947, CLB-C59910 |
| Study First Received: | July 5, 2000 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00005964 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage III adult diffuse large cell lymphoma stage III adult immunoblastic large cell lymphoma stage III adult lymphoblastic lymphoma stage IV adult diffuse large cell lymphoma stage IV adult immunoblastic large cell lymphoma stage IV adult lymphoblastic lymphoma |
contiguous stage II adult immunoblastic large cell lymphoma contiguous stage II adult diffuse large cell lymphoma contiguous stage II adult lymphoblastic lymphoma noncontiguous stage II adult immunoblastic large cell lymphoma noncontiguous stage II adult diffuse large cell lymphoma noncontiguous stage II adult lymphoblastic lymphoma |
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Anti-Inflammatory Agents Prednisone Immunologic Factors Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Cyclophosphamide Hormones Lymphoblastic Lymphoma Etoposide phosphate Lymphoma, Large-cell, Immunoblastic Lymphoma, Small Cleaved-cell, Diffuse Anti-Bacterial Agents Lymphoma, Large-Cell, Immunoblastic Lymphoma, Large-cell Aggression |
Lymphoma Etoposide Alkylating Agents Lymphoma, Large B-Cell, Diffuse Immunoproliferative Disorders Antineoplastic Agents, Hormonal Vincristine Antimitotic Agents Immunosuppressive Agents Glucocorticoids Doxorubicin Lymphatic Diseases Tubulin Modulators Antineoplastic Agents, Alkylating Lymphoproliferative Disorders |
|
Anti-Inflammatory Agents Prednisone Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Cyclophosphamide Antibiotics, Antineoplastic Hormones Therapeutic Uses Lymphoma, Large-Cell, Immunoblastic Lymphoma Alkylating Agents Immunoproliferative Disorders |
Neoplasms by Histologic Type Antineoplastic Agents, Hormonal Immune System Diseases Mitosis Modulators Vincristine Antimitotic Agents Glucocorticoids Immunosuppressive Agents Doxorubicin Pharmacologic Actions Lymphatic Diseases Neoplasms Tubulin Modulators Myeloablative Agonists Antineoplastic Agents, Alkylating |
