Comparison of Two Combination Chemotherapy Regimens in Treating Patients With Previously Untreated Aggressive Stage II, Stage III, or Stage IV Non-Hodgkin's Lymphoma



Status:Completed
Conditions:Lymphoma, Lymphoma
Therapuetic Areas:Oncology
Healthy:No
Age Range:Any
Updated:7/14/2016
Start Date:May 2000
End Date:March 2006

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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.

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.

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
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