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

Sponsor

Alliance for Clinical Trials in Oncology (Other)

Overall Status

Completed

CT.gov ID

NCT00005964

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Locations

Arm

Duration (Months)

1.3

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Lymphoma	Biological: filgrastim Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: etoposide Drug: prednisone Drug: vincristine sulfate	Phase 2

Detailed Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

59 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

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 1, 2000

Actual Primary Completion Date :

Mar 1, 2006

Actual Study Completion Date :

Mar 1, 2006

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Chemotherapy + prednisone + filgrastim 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.	Biological: filgrastim Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: etoposide Drug: prednisone Drug: vincristine sulfate

Arm

Intervention/Treatment

Experimental: Chemotherapy + prednisone + filgrastim

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.

Biological: filgrastim

Drug: cyclophosphamide

Drug: doxorubicin hydrochloride

Drug: etoposide

Drug: prednisone

Drug: vincristine sulfate

Outcome Measures

Primary Outcome Measures

Response rate [Up to 5 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Veterans Affairs Medical Center - Birmingham	Birmingham	Alabama	United States	35233-1996
2	University of California San Diego Cancer Center	La Jolla	California	United States	92093-0658
3	Veterans Affairs Medical Center - San Francisco	San Francisco	California	United States	94121
4	UCSF Cancer Center and Cancer Research Institute	San Francisco	California	United States	94143-0128
5	CCOP - Christiana Care Health Services	Wilmington	Delaware	United States	19899
6	Lombardi Cancer Center	Washington	District of Columbia	United States	20007
7	Walter Reed Army Medical Center	Washington	District of Columbia	United States	20307-5000
8	CCOP - Mount Sinai Medical Center	Miami Beach	Florida	United States	33140
9	Veterans Affairs Medical Center - Chicago (Westside Hospital)	Chicago	Illinois	United States	60612
10	University of Chicago Cancer Research Center	Chicago	Illinois	United States	60637-1470
11	Holden Comprehensive Cancer Center at The University of Iowa	Iowa City	Iowa	United States	52242-1009
12	Veterans Affairs Medical Center - Togus	Togus	Maine	United States	04330
13	Marlene & Stewart Greenebaum Cancer Center, University of Maryland	Baltimore	Maryland	United States	21201
14	Dana-Farber Cancer Institute	Boston	Massachusetts	United States	02115
15	University of Massachusetts Memorial Medical Center	Worcester	Massachusetts	United States	01655
16	Veterans Affairs Medical Center - Minneapolis	Minneapolis	Minnesota	United States	55417
17	University of Minnesota Cancer Center	Minneapolis	Minnesota	United States	55455
18	Veterans Affairs Medical Center - Columbia (Truman Memorial)	Columbia	Missouri	United States	65201
19	Ellis Fischel Cancer Center - Columbia	Columbia	Missouri	United States	65203
20	Barnes-Jewish Hospital	Saint Louis	Missouri	United States	63110
21	University of Nebraska Medical Center	Omaha	Nebraska	United States	68198-3330
22	CCOP - Southern Nevada Cancer Research Foundation	Las Vegas	Nevada	United States	89106
23	Norris Cotton Cancer Center	Lebanon	New Hampshire	United States	03756-0002
24	Veterans Affairs Medical Center - Buffalo	Buffalo	New York	United States	14215
25	Roswell Park Cancer Institute	Buffalo	New York	United States	14263-0001
26	CCOP - North Shore University Hospital	Manhasset	New York	United States	11030
27	North Shore University Hospital	Manhasset	New York	United States	11030
28	Memorial Sloan-Kettering Cancer Center	New York	New York	United States	10021
29	New York Presbyterian Hospital - Cornell Campus	New York	New York	United States	10021
30	Mount Sinai Medical Center, NY	New York	New York	United States	10029
31	State University of New York - Upstate Medical University	Syracuse	New York	United States	13210
32	Veterans Affairs Medical Center - Syracuse	Syracuse	New York	United States	13210
33	CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.	Syracuse	New York	United States	13217
34	Lineberger Comprehensive Cancer Center, UNC	Chapel Hill	North Carolina	United States	27599-7295
35	Veterans Affairs Medical Center - Durham	Durham	North Carolina	United States	27705
36	Duke Comprehensive Cancer Center	Durham	North Carolina	United States	27710
37	CCOP - Southeast Cancer Control Consortium	Winston-Salem	North Carolina	United States	27104-4241
38	Comprehensive Cancer Center at Wake Forest University	Winston-Salem	North Carolina	United States	27157-1082
39	Arthur G. James Cancer Hospital - Ohio State University	Columbus	Ohio	United States	43210-1240
40	Rhode Island Hospital	Providence	Rhode Island	United States	02903
41	University of Tennessee, Memphis Cancer Center	Memphis	Tennessee	United States	38103
42	Veterans Affairs Medical Center - Memphis	Memphis	Tennessee	United States	38104
43	CCOP - Southwestern Vermont Regional Cancer Center	Bennington	Vermont	United States	05201
44	Vermont Cancer Center	Burlington	Vermont	United States	05401-3498
45	Veterans Affairs Medical Center - White River Junction	White River Junction	Vermont	United States	05009
46	Veterans Affairs Medical Center - Richmond	Richmond	Virginia	United States	23249
47	MBCCOP - Massey Cancer Center	Richmond	Virginia	United States	23298-0037