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Combination Chemotherapy in Treating Older Patients With Non-Hodgkin's Lymphoma
This study is ongoing, but not recruiting participants.
First Received: June 6, 2002   Last Updated: February 6, 2009   History of Changes
Sponsored by: European Organization for Research and Treatment of Cancer
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00039351
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

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


Condition Intervention Phase
Lymphoma
Drug: cyclophosphamide
Drug: prednisone
Drug: vincristine sulfate
Radiation: radiation therapy
Phase II

MedlinePlus related topics: Cancer Lymphoma Radiation Therapy
Drug Information available for: Cyclophosphamide Prednisone Vincristine Vincristine sulfate
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: Diffuse Large B Cell And Peripheral T-Cell Non-Hodgkin's Lymphoma In The Frail Elderly. Progressive And Cautious Treatment Strategy In Poor Status Patients. A Phase II Trial With Emphasis On Geriatric Assessment And Quality Of Life

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

Study Start Date: March 2002
Detailed Description:

OBJECTIVES:

  • Determine the complete remission (CR) rate and duration of CR in frail elderly patients with diffuse large B-cell or peripheral T-cell non-Hodgkin's lymphoma treated with cyclophosphamide, vincristine, and prednisone.
  • Determine the time to progression and overall survival of patients treated with this regimen.
  • Determine the severe toxicity rate of this regimen in these patients.
  • Assess the quality of life of patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive cyclophosphamide IV and vincristine IV on day 1 and oral prednisone on days 1-5. Treatment repeats every 3 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.

Patients with stage I or II non-Hodgkin's lymphoma (NHL), no baseline lactate dehydrogenase (LDH) elevation, baseline WHO performance status 0-1, and longest tumor diameter of less than 5 cm, who achieve partial response (PR) or complete response (CR), receive 1 additional course of chemotherapy.

Patients then undergo involved-field radiotherapy once daily 5 days a week for 3.5-4 weeks.

Patients with stage I or II NHL, a baseline LDH elevation, and/or baseline WHO performance status 2-4, and/or longest tumor diameter of at least 5 cm, who achieve PR or CR, receive 3 additional courses of chemotherapy. Patients then undergo involved-field radiotherapy once daily 5 days a week for 3.5-4 weeks.

Patients with stage III or IV NHL who achieve CR or PR receive 3 additional courses of chemotherapy. Patients then undergo consolidative radiotherapy once daily 5 days a week for 2.5-3 weeks.

Quality of life is assessed at baseline, after the third chemotherapy course, at the end of chemotherapy, every 6 months for 3 years, and then annually thereafter.

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

PROJECTED ACCRUAL: A total of 29-56 patients will be accrued for this study within 12-18 months.

  Eligibility

Ages Eligible for Study:   70 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of diffuse large B-cell or peripheral T-cell non-Hodgkin's lymphoma (NHL)

    • No Burkitt's-like lymphoma
    • Small cells in bone marrow allowed
  • Previously untreated NHL
  • At least 1 measurable lesion

    • At least 1.1 cm
  • Poor physiological status with at least 1 of the following:

    • WHO performance status of 3-4
    • LVEF less than 50%
    • Creatinine clearance less than 50 mL/min
    • Neutrophil count no greater than 1,500/mm^3
    • Platelet count no greater than 100,000/mm^3
    • Concurrent severe disease that would preclude cyclophosphamide, vincristine, prednisolone, and doxorubicin
  • No cerebral or meningeal involvement

PATIENT CHARACTERISTICS:

Age:

  • 70 and over

Performance status:

  • See Disease Characteristics

Life expectancy:

  • Not specified

Hematopoietic:

  • See Disease Characteristics

Hepatic:

  • Not specified

Renal:

  • See Disease Characteristics

Other:

  • HIV negative
  • No other malignancy within the past 5 years except adequately treated basal cell skin cancer, curatively treated carcinoma in situ of the cervix, or curatively treated solid tumor
  • No active infection
  • No psychological, familial, sociological, or geographical condition that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • See Disease Characteristics

Endocrine therapy:

  • Not specified

Radiotherapy:

  • Not specified

Surgery:

  • Not specified

Other:

  • No other concurrent investigational drugs
  • No other concurrent antineoplastic agents
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00039351

Locations
Belgium
Centre Hospitalier Universitaire Brugmann
Brussels, Belgium, B 1020
U.Z. Gasthuisberg
Leuven, Belgium, B-3000
Ziekenhuis Network Antwerpen Middelheim
Antwerp, Belgium, 2020
Egypt
National Cancer Institute of Egypt
Cairo, Egypt
France
Hopital Saint Andre
Bordeaux, France, 33075
Centre Hospitalier de Dax
Dax, France, 40107
Hopital Robert Boulin
Libourne, France, 33500
Centre D'Oncologie Du Pays-Basque
Bayonne, France, F-64100
Institut Bergonie
Bordeaux, France, 33076
Polyclinique de Francheville
Perigueux, France, 24004
Netherlands
Academisch Ziekenhuis Groningen
Groningen, Netherlands, 9700 RB
Onze Lieve Vrouwe Gasthuis
Amsterdam, Netherlands, 1091 HA
University Medical Center Nijmegen
Nijmegen, Netherlands, NL-6500 HB
Portugal
Hospitais da Universidade de Coimbra (HUC)
Coimbra, Portugal, 3001-301
Switzerland
Hopitaux Universitaires de Geneve
Thonex-Geneve, Switzerland, CH-1226
United Kingdom
Dumfries Royal Infirmary
Dumfries, United Kingdom, DG1 4AP
United Kingdom, England
New Cross Hospital
Wolverhampton, England, United Kingdom, WV10 0QP
Sponsors and Collaborators
European Organization for Research and Treatment of Cancer
Investigators
Investigator: Pierre Soubeyran, MD, PhD Institut Bergonie
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000069376, EORTC-20992
Study First Received: June 6, 2002
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00039351     History of Changes
Health Authority: United States: Federal Government

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

Study placed in the following topic categories:
Anti-Inflammatory Agents
Prednisone
Immunologic Factors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Quality of Life
Cyclophosphamide
Hormones
Lymphoma, Small Cleaved-cell, Diffuse
Lymphoma, T-Cell
Lymphoma, Large-cell
Lymphoma
Alkylating Agents
Lymphoma, Large B-Cell, Diffuse
Immunoproliferative Disorders
Antineoplastic Agents, Hormonal
Immunoblastic Lymphadenopathy
Vincristine
Antimitotic Agents
Immunosuppressive Agents
Glucocorticoids
Lymphatic Diseases
Tubulin Modulators
Antineoplastic Agents, Alkylating
Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin
Antirheumatic Agents
Antineoplastic Agents, Phytogenic

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

ClinicalTrials.gov processed this record on May 07, 2009