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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT00032019
First received: March 8, 2002
Last updated: September 25, 2013
Last verified: September 2013

March 8, 2002
September 25, 2013
February 2002
December 2004   (final data collection date for primary outcome measure)
Response [ Time Frame: 5 months ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00032019 on ClinicalTrials.gov Archive Site
  • Progression free Survival [ Time Frame: Study entry to progression or tx related death ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: Study entry to death from any cause ] [ Designated as safety issue: No ]
  • Toxicity [ Time Frame: q 2cycles on Tx, then q 6 mon for 2 yrs, then at relapse ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
Not Provided
 
Combination Chemotherapy and Monoclonal Antibody Therapy in Treating Patients With Non-Hodgkin's Lymphoma
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)

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.

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.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Lymphoma
  • Biological: filgrastim
    Cycle 1: 300 ug (BW < = 70 kg) or 480ug (BW >70 kg) sub Q injection Day 6 until ANC > 5000/uL after nadir counts Subsequent cycle dosages based on previous cycle toxicity or Day 1 Tx toxicity
    Other Name: G-CSF
  • Biological: rituximab
    375 mg/sq m IV infusion Day 1 Cycle 1 Subsequent cycle dosage based on previous cycle or day 1 of tx toxicities
  • Drug: cyclophosphamide
    750 mg/sq m IV infusion on Day 5 Cycle 1 Subsequent cycle dosage based on previous cycle or day 1 treatment toxicities
  • Drug: doxorubicin hydrochloride
    10 mg/sq m/day continuous IV infusion on Days 1-4 Cycle 1 Subsequent cycle dosages based on previous cycle and Day 1 treatment toxicities
  • Drug: etoposide
    50 mg/sq m/day continuous IV infusion Days 1-4 Cycle 1 Subsequent cycle dosages based on previous cycle and day 1 of treatment toxicities
  • Drug: prednisone
    60 mg/sq m PO bid days 1-5 of ea cycle
  • Drug: vincristine sulfate
    0.4 mg/sq m/day continuous IV infusion uncapped on Days 1-4 Cycle 1 Subsequent cycle dosages based on previous cycle and day 1 of treatment toxicities
Experimental: EPOCH-Rituximab
Addition of monoclonal antibody therapy to chemotherapy for treatment of pts with aggressive CD20+ NHL
Interventions:
  • Biological: filgrastim
  • Biological: rituximab
  • Drug: cyclophosphamide
  • Drug: doxorubicin hydrochloride
  • Drug: etoposide
  • Drug: prednisone
  • Drug: vincristine sulfate

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
78
April 2009
December 2004   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States,   Puerto Rico
 
NCT00032019
CDR0000069249, U10CA031946, CALGB-50103
No
Alliance for Clinical Trials in Oncology
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Study Chair: Wyndham H. Wilson, MD, PhD National Cancer Institute (NCI)
Alliance for Clinical Trials in Oncology
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP