Combination Chemotherapy With or Without Etoposide in Treating Older Patients With Non-Hodgkin's Lymphoma

NCT00060385 | Terminated Phase 2

• 1 other identifier: EORTC-20991
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

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 cancer cells. It is not yet known which combination chemotherapy regimen is more effective in treating non-Hodgkin's lymphoma. PURPOSE: Randomized phase II/III trial to compare the effectiveness of combination chemotherapy with or without etoposide in treating older patients who have non-Hodgkin's lymphoma that has not been previously treated.

Conditions

Lymphoma

Keywords

stage I adult T-cell leukemia/lymphoma; stage I cutaneous T-cell non-Hodgkin lymphoma; stage II adult T-cell leukemia/lymphoma; stage II cutaneous T-cell non-Hodgkin lymphoma; stage III adult T-cell leukemia/lymphoma; stage III cutaneous T-cell non-Hodgkin lymphoma; stage IV adult T-cell leukemia/lymphoma; stage IV cutaneous T-cell non-Hodgkin lymphoma; stage I mycosis fungoides/Sezary syndrome; stage II mycosis fungoides/Sezary syndrome; stage III mycosis fungoides/Sezary syndrome; stage IV mycosis fungoides/Sezary syndrome; contiguous stage II adult diffuse large cell lymphoma; noncontiguous stage II adult diffuse large cell lymphoma; stage I adult diffuse large cell lymphoma; stage III adult diffuse large cell lymphoma; stage IV adult diffuse large cell lymphoma

Interventions

CHOP regimen DRUG

EPOCH regimen DRUG

cyclophosphamide DRUG

doxorubicin hydrochloride DRUG

etoposide DRUG

prednisone DRUG

vincristine sulfate DRUG

radiation therapy RADIATION

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

DISEASE CHARACTERISTICS: * Diagnosis of diffuse large B-cell\* or peripheral T-cell non-Hodgkin's lymphoma by REAL/WHO classification, including the following: * All morphological and clinical variants * All Ann Arbor stages NOTE: \*Presence of a small cell, indolent lymphoma component in the bone marrow biopsy is allowed * No Burkitt-like lymphoma * Previously untreated disease * No cerebral or meningeal involvement * At least 1 measurable target lesion at least 1.1 cm by the Cheson criteria PATIENT CHARACTERISTICS: Age * 70 and over Performance status * WHO 0-2 Life expectancy * Not specified Hematopoietic * Absolute neutrophil count greater than 1,500/mm\^3 * Platelet count greater than 100,000/mm\^3 (unless related to bone marrow infiltration) Hepatic * Bilirubin less than 1.8 mg/dL\* * AST or ALT less than 2.5 times upper limit of normal (ULN)\* * Alkaline phosphatase less than 4 times ULN\* NOTE: \*Values above these thresholds are allowed only if related to non-Hodgkin's lymphoma Renal * Creatinine clearance at least 50 mL/min Cardiovascular * LVEF at least 50% Other * HIV negative * No history of concurrent severe disease that would preclude study treatment * No other prior or concurrent malignancy except adequately treated basal cell skin cancer, curatively treated carcinoma in situ of the cervix, or other curatively treated solid malignancy with no evidence of disease for at least 5 years prior to study entry * No psychological, familial, sociological, or geographical condition that would preclude study compliance and follow-up PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * Not specified Endocrine therapy * Not specified Radiotherapy * Not specified Surgery * Not specified Other * No concurrent participation in another investigational drug study * No other concurrent antineoplastic agents

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• European Organisation for Research and Treatment of Cancer - EORTC: lead

Study Sites (1)

U.Z. Gasthuisberg

Leuven, B-3000, Belgium

Location

MeSH Terms

Conditions

Lymphoma; Precursor T-Cell Lymphoblastic Leukemia-Lymphoma; Lymphoma, T-Cell, Cutaneous; Mycosis Fungoides; Sezary Syndrome; Lymphoma, Large B-Cell, Diffuse

Interventions

VAP-cyclo protocol; EPOCH protocol; Cyclophosphamide; Doxorubicin; Etoposide; Prednisone; Vincristine; Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid; Leukemia; Hematologic Diseases; Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma, B-Cell

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Glucosides; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Therapeutics

Study Officials

• Pierre Soubeyran, MD, PhD

  Institut Bergonié

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2003
• First Posted: May 7, 2003
• Study Start: March 1, 2003
• Primary Completion: August 1, 2004
• Last Updated: September 24, 2012

Record last verified: 2012-09

Locations

BE (1)