Lymphoma Clinical Trial
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)
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.
;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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