Combination Chemotherapy and Monoclonal Antibody Therapy in Treating Patients With Non-Hodgkin's Lymphoma

Phase 2

Completed

• Conditions: Lymphoma
• Interventions: Biological: filgrastim; Biological: rituximab; Drug: cyclophosphamide; Drug: doxorubicin hydrochloride; Drug: etoposide; Drug: prednisone; Drug: vincristine sulfate

• Registration Number: NCT00032019
• Lead Sponsor: Alliance for Clinical Trials in Oncology

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies such as rituximab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining rituximab with combination chemotherapy may kill more cancer cells.

PURPOSE: Phase II trial to study the effectiveness of combining rituximab with combination chemotherapy in treating patients who have previously untreated non-Hodgkin's lymphoma.

Detailed Description

OBJECTIVES:

* Determine the response rate, progression-free survival, and overall survival of patients with previously untreated aggressive CD20+ B-cell diffuse large cell or immunoblastic large cell lymphoma treated with rituximab, doxorubicin, etoposide, vincristine, prednisone, and cyclophosphamide.

* Determine the toxic effects of this regimen in these patients.

* Correlate tumor proliferation rate (MIB-1), bcl-2 expression, and p53 overexpression with complete response rate, progression-free survival, and overall survival in patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive rituximab IV on day 1; doxorubicin IV continuously, etoposide IV continuously, and vincristine IV continuously on days 1-4; oral prednisone twice daily on days 1-5; and cyclophosphamide IV on day 5. Patients also receive filgrastim (G-CSF) subcutaneously beginning on day 6 and continuing until blood counts recover. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. After 4 courses, patients with complete or partial response receive 2 additional courses.

Patients are followed every 3 months for 2 years and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 25-50 patients will be accrued for this study within 1 year.

Study Timeline

• Study Start: 2002-02
• Study First Submitted: 2002-03-08
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Primary Completion: 2004-12
• Study Completion: 2009-04
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-15
• Last Update Posted: 2016-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 78

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
EPOCH-Rituximab	prednisone	Addition of monoclonal antibody therapy to chemotherapy for treatment of pts with aggressive CD20+ NHL
EPOCH-Rituximab	filgrastim	Addition of monoclonal antibody therapy to chemotherapy for treatment of pts with aggressive CD20+ NHL
EPOCH-Rituximab	rituximab	Addition of monoclonal antibody therapy to chemotherapy for treatment of pts with aggressive CD20+ NHL
EPOCH-Rituximab	etoposide	Addition of monoclonal antibody therapy to chemotherapy for treatment of pts with aggressive CD20+ NHL
EPOCH-Rituximab	vincristine sulfate	Addition of monoclonal antibody therapy to chemotherapy for treatment of pts with aggressive CD20+ NHL
EPOCH-Rituximab	cyclophosphamide	Addition of monoclonal antibody therapy to chemotherapy for treatment of pts with aggressive CD20+ NHL
EPOCH-Rituximab	doxorubicin hydrochloride	Addition of monoclonal antibody therapy to chemotherapy for treatment of pts with aggressive CD20+ NHL

Primary Outcome Measures

Name	Time	Method
Response	5 months

Secondary Outcome Measures

Name	Time	Method
Progression free Survival	Study entry to progression or tx related death
Overall survival	Study entry to death from any cause
Toxicity	q 2cycles on Tx, then q 6 mon for 2 yrs, then at relapse

Trial Locations

Locations (81)

Northeast Alabama Regional Medical Center; 🇺🇸 Anniston, Alabama, United States

Rebecca and John Moores UCSD Cancer Center; 🇺🇸 La Jolla, California, United States

Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center; 🇺🇸 Los Angeles, California, United States

Naval Medical Center - San Diego; 🇺🇸 San Diego, California, United States

Veterans Affairs Medical Center - San Diego; 🇺🇸 San Diego, California, United States

UCSF Comprehensive Cancer Center; 🇺🇸 San Francisco, California, United States

Veterans Affairs Medical Center - San Francisco; 🇺🇸 San Francisco, California, United States

CCOP - Christiana Care Health Services; 🇺🇸 Newark, Delaware, United States

Lombardi Cancer Center at Georgetown University Medical Center; 🇺🇸 Washington, District of Columbia, United States

Walter Reed Army Medical Center; 🇺🇸 Washington, District of Columbia, United States

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