Comparison of Two Combination Chemotherapy Regimens in Treating Patients With Previously Untreated Aggressive Stage II, Stage III, or Stage IV Non-Hodgkin's Lymphoma
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.
Drug: EPOCH regimen
Drug: doxorubicin hydrochloride
Drug: vincristine sulfate
|Study Design:||Primary Purpose: 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.