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Combination Chemotherapy and Monoclonal Antibody Therapy in Treating Patients With Non-Hodgkin's Lymphoma
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: Cancer and Leukemia Group B
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00032019
  Purpose

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.


Condition Intervention Phase
Lymphoma
Drug: cyclophosphamide
Drug: doxorubicin hydrochloride
Drug: etoposide
Drug: filgrastim
Drug: prednisone
Drug: rituximab
Drug: vincristine sulfate
Phase II

MedlinePlus related topics: Cancer Lymphoma
Drug Information available for: Doxorubicin Doxorubicin hydrochloride Cyclophosphamide Filgrastim Etoposide Prednisone Vincristine sulfate Vincristine Rituximab Etoposide phosphate Immunoglobulins Globulin, Immune
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment
Official Title: Phase II Study Of Dose-Adjusted Epoch-Rituximab (EPOCH-R) Chemotherapy For Patients With Previously Untreated Aggressive CD20+ B-Cell Non-Hodgkin's Lymphoma (NHL)

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: February 2002
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed stage II, III, or IV diffuse large cell lymphoma and WHO variants

    • CD20+ large B-cell lymphoma, including those with immunoblastic features
    • CD20+ thymic B-cell lymphoma
    • No evidence of indolent lymphoma
    • No mantle cell lymphomas or equivocal B-cell lymphomas that express markers of mantle cell lymphoma (e.g., cyclin D) or other subtypes
  • No known lymphomatous involvement of the CNS, including the parenchyma or leptomeninges

PATIENT CHARACTERISTICS:

Age:

  • Not specified

Performance status:

  • CALGB 0-2

Life expectancy:

  • Not specified

Hematopoietic:

  • Absolute neutrophil count at least 1,000/mm3*
  • Platelet count at least 100,000/mm3* NOTE: * Unless due to lymphoma

Hepatic:

  • Bilirubin no greater than 2.0 mg/dL* NOTE: * Unless due to lymphoma or Gilbert's disease

Renal:

  • Creatinine no greater than 1.5 mg/dL* NOTE: * Unless due to lymphoma

Cardiovascular:

  • LVEF greater than 45%
  • No ischemic heart disease
  • No myocardial infarction or congestive heart failure within the past year

Other:

  • HIV negative
  • Not pregnant or nursing
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • No prior cytotoxic chemotherapy
  • No other concurrent chemotherapy

Endocrine therapy:

  • Prior short-course of glucocorticoids allowed
  • No concurrent hormones except for non-disease-related conditions (e.g., insulin for diabetes)
  • No concurrent steroids except for adrenal failure
  • No concurrent dexamethasone or other steroidal antiemetics

Radiotherapy:

  • Prior limited-field radiotherapy allowed

Surgery:

  • Not specified
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00032019

  Show 81 Study Locations
Sponsors and Collaborators
Cancer and Leukemia Group B
Investigators
Study Chair: Wyndham H. Wilson, MD, PhD National Cancer Institute (NCI)
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Publications of Results:
Wilson WH, Porcu P, Hurd D, et al.: Phase II study of dose-adjusted EPOCH-R in untreated de novo CD20+ diffuse large B-cell lymphoma (DLBCL)-CALGB 50103. [Abstract] J Clin Oncol 23 (Suppl 16): A-6530, 567s, 2005.

Study ID Numbers: CDR0000069249, CALGB-50103
Study First Received: March 8, 2002
Last Updated: December 13, 2008
ClinicalTrials.gov Identifier: NCT00032019  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage III adult diffuse large cell lymphoma
stage III adult immunoblastic large cell lymphoma
stage IV adult diffuse large cell lymphoma
stage IV adult immunoblastic large cell lymphoma
contiguous stage II adult immunoblastic large cell lymphoma
contiguous stage II adult diffuse large cell lymphoma
noncontiguous stage II adult immunoblastic large cell lymphoma
noncontiguous stage II adult diffuse large cell lymphoma

Study placed in the following topic categories:
Prednisone
Lymphoma, Large B-Cell, Diffuse
Immunoproliferative Disorders
Rituximab
Lymphoma, small cleaved-cell, diffuse
Vincristine
Cyclophosphamide
Etoposide phosphate
Doxorubicin
Lymphoma, large-cell, immunoblastic
Antibodies, Monoclonal
Lymphoma, B-Cell
Lymphoma, large-cell
Lymphatic Diseases
Antibodies
B-cell lymphomas
Lymphoma, Large-Cell, Immunoblastic
Lymphoma, Non-Hodgkin
Aggression
Lymphoproliferative Disorders
Etoposide
Lymphoma
Immunoglobulins

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Neoplasms by Histologic Type
Antineoplastic Agents, Hormonal
Immune System Diseases
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Mitosis Modulators
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Antimitotic Agents
Antibiotics, Antineoplastic
Hormones
Glucocorticoids
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Therapeutic Uses
Tubulin Modulators
Myeloablative Agonists
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Antineoplastic Agents, Phytogenic
Alkylating Agents

ClinicalTrials.gov processed this record on January 16, 2009