Comparison of Two Combination Chemotherapy Regimens in Treating Patients With Stage III or Stage IV Hodgkin's Lymphoma

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Lymphoma Trials Office
Lymphoma Study Association
Grup per l'Estudi dels Limfomes de Catalunya i Balears
NCIC Clinical Trials Group
Australasian Leukaemia and Lymphoma Group
Nordic Lymphoma Group
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier:
NCT00049595
First received: November 12, 2002
Last updated: June 13, 2014
Last verified: June 2014
  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 cancer cells. It is not yet known which combination chemotherapy regimen is more effective in treating stage III or stage IV Hodgkin's lymphoma.

PURPOSE: Randomized phase III trial to compare the effectiveness of two combination chemotherapy regimens in treating patients who have stage III or stage IV Hodgkin's lymphoma.


Condition Intervention Phase
Lymphoma
Biological: bleomycin sulfate
Biological: filgrastim
Biological: pegfilgrastim
Drug: ABVD regimen
Drug: BEACOPP regimen
Drug: cyclophosphamide
Drug: dacarbazine
Drug: doxorubicin hydrochloride
Drug: etoposide
Drug: prednisone
Drug: procarbazine hydrochloride
Drug: vinblastine sulfate
Drug: vincristine sulfate
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: BEACOPP (4 Cycles Escalated + 4 Cycles Baseline) Versus ABVD (8 Cycles) In Stage III & IV Hodgkin's Lymphoma

Resource links provided by NLM:


Further study details as provided by European Organisation for Research and Treatment of Cancer - EORTC:

Primary Outcome Measures:
  • Event-free survival [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Complete response as assessed by Cheson criteria adapted to Hodgkin's lymphoma [ Designated as safety issue: No ]
  • Disease-free survival in patients with complete response [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • Quality of life as assessed by European Organization for Research of the Treatment of Cancer (EORTC) Quality of Life Questionnaire (QoLQ) C30 version 3.0 [ Designated as safety issue: No ]
  • Occurrence of secondary malignancies [ Designated as safety issue: No ]

Enrollment: 552
Study Start Date: August 2002
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: ABVD
8 cycles of ABVD
Biological: bleomycin sulfate Drug: ABVD regimen Drug: dacarbazine Drug: doxorubicin hydrochloride Drug: vinblastine sulfate
Experimental: BEACOPP
4 cycles of BEACOPP Escalated + 4 cycles of BEACOPP Baseline
Biological: bleomycin sulfate Biological: filgrastim Biological: pegfilgrastim Drug: BEACOPP regimen Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: etoposide Drug: prednisone Drug: procarbazine hydrochloride Drug: vincristine sulfate

Detailed Description:

OBJECTIVES:

  • Compare event-free survival of patients with stage III or IV Hodgkin's lymphoma treated with bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, and prednisone vs doxorubicin, bleomycin, vinblastine, and dacarbazine.
  • Compare complete response, disease-free survival, and overall survival of patients treated with these regimens.
  • Compare quality of life of patients treated with these regimens.
  • Compare occurrence of second malignancies in patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to International Prognostic Score (3 vs 4 or more) and participating center. Patients are randomized to 1 of 2 treatment arms.

  • Arm I (BEACOPP): Patients receive doxorubicin IV over 5 minutes and cyclophosphamide IV on day 1; etoposide IV over 30 minutes on days 1-3; oral procarbazine on days 1-7; oral prednisone on days 1-14; and vincristine IV and bleomycin IV or intramuscularly (IM) on day 8. Patients may receive dexamethasone in place of prednisone. Patients also receive filgrastim (G-CSF) subcutaneously (SC) beginning on day 9 and continuing until blood counts recover or pegfilgrastim SC on day 9 only. Treatment repeats every 22 days for 8 courses (4 courses escalated dose followed by 4 courses baseline dose) in the absence of disease progression or unacceptable toxicity.
  • Arm II (ABVD): Patients receive doxorubicin IV over 5 minutes, bleomycin IV or IM, vinblastine IV, and dacarbazine IV over 5-10 minutes on days 1 and 15. Treatment repeats every 28 days for 8 courses in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, at the end of therapy, and then annually for 10 years.

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

PROJECTED ACCRUAL: A total of 550 patients (225 per treatment arm) will be accrued for this study within 5.5 years.

  Eligibility

Ages Eligible for Study:   16 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed Hodgkin's lymphoma

    • No lymphocyte predominant, nodular type (nodular paragranuloma)
    • Clinical stage III or IV disease
  • At least 1 bidimensionally measurable target lesion or extranodal lesion
  • International Prognostic Score of at least 3

PATIENT CHARACTERISTICS:

Age

  • 16 to 60

Performance status

  • WHO 0-2

Life expectancy

  • Not specified

Hematopoietic

  • WBC greater than 2,000/mm^3
  • Platelet count greater than 100,000/mm^3

Hepatic

  • No prior uncontrolled hepatitis B viral infection
  • Bilirubin no greater than 2.5 times normal (unless due to Hodgkin's lymphoma)

Renal

  • Creatinine no greater than 2.0 mg/dL (unless due to Hodgkin's lymphoma)

Cardiovascular

  • No severe cardiac disease that would limit normal life expectancy or preclude study
  • LVEF at least 50%

Pulmonary

  • No severe pulmonary disease that would limit normal life expectancy or preclude study
  • Respiratory function at least 30%

Other

  • HIV negative
  • HTLV1 negative
  • No severe active infection
  • No severe neurological or metabolic disease that would limit normal life expectancy or preclude study
  • No other prior or concurrent malignancy except basal cell skin cancer or carcinoma in situ of the cervix
  • No psychological, familial, sociological, or geographical condition that would preclude study
  • Not pregnant or nursing
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • Not specified

Endocrine therapy

  • Not specified

Radiotherapy

  • No concurrent radiotherapy

Surgery

  • Not specified

Other

  • No prior therapy for Hodgkin's lymphoma
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00049595

  Hide Study Locations
Locations
Australia, Australian Capital Territory
Canberra Hospital
Woden, Australian Capital Territory, Australia, 2606
Australia, New South Wales
Nepean Cancer Care Centre at Nepean Hospital
Kingswood, New South Wales, Australia, 2747
Westmead Institute for Cancer Research at Westmead Hospital
Westmead, New South Wales, Australia, 2145
Australia, Queensland
Princess Alexandra Hospital
Brisbane, Queensland, Australia, 4102
Australia, Victoria
Peter MacCallum Cancer Centre
East Melbourne, Victoria, Australia, 3002
St. Vincent's Hospital - Melbourne
Fitzroy, Victoria, Australia, 3065
Australia, Western Australia
Royal Perth Hospital
Perth, Western Australia, Australia, 6000
Belgium
Ziekenhuis Netwerk Antwerpen Middelheim
Antwerp, Belgium, 2020
AZ Sint-Jan
Brugge, Belgium, 8000
Hopital Universitaire Erasme
Brussels, Belgium, 1070
Institut Jules Bordet
Brussels, Belgium, 1000
Centre Hospitalier Universitaire Brugmann
Brussels, Belgium, B 1020
Cliniques Universitaires Saint-Luc
Brussels, Belgium, 1200
Centre Hospitalier Notre Dame - Reine Fabiola
Charleroi, Belgium, 6000
Universitair Ziekenhuis Antwerpen
Edegem, Belgium, B-2650
Algemeen Ziekenhuis Sint Lucas
Ghent, Belgium, B-9000
Hopital de Jolimont
Haine Saint Paul, Belgium, 7100
U.Z. Gasthuisberg
Leuven, Belgium, B-3000
Centre Hospitalier Regional de la Citadelle
Liege, Belgium, 4000
Clinique Universitaire De Mont-Godinne
Mont-Godinne Yvoir, Belgium, 5530
H. Hartziekenhuis - Roeselaere
Roeselare, Belgium, 8800
Canada, Alberta
Tom Baker Cancer Centre - Calgary
Calgary, Alberta, Canada, T2N 4N2
Cross Cancer Institute at University of Alberta
Edmonton, Alberta, Canada, T6G 1Z2
Canada, Manitoba
Centre Hospitalier De Dunkerque - CHD
Winnipeg, Manitoba, Canada, R3E 0V9
CancerCare Manitoba
Winnipeg, Manitoba, Canada, R3E 0V9
Canada, New Brunswick
Moncton Hospital
Moncton, New Brunswick, Canada, E1C 6ZB
Canada, Newfoundland and Labrador
Doctor H. Bliss Murphy Cancer Centre
St. Johns, Newfoundland and Labrador, Canada, A1B 3V6
Canada, Nova Scotia
Nova Scotia Cancer Centre
Halifax, Nova Scotia, Canada, B3H 1V7
Canada, Ontario
Cancer Centre of Southeastern Ontario at Kingston General Hospital
Kingston, Ontario, Canada, K7L 5P9
London Regional Cancer Program at London Health Sciences Centre
London, Ontario, Canada, N6A 4L6
Ottawa Hospital Regional Cancer Centre - General Campus
Ottawa, Ontario, Canada, K1H 8L6
Northeastern Ontario Regional Cancer Centre
Sudbury, Ontario, Canada, P3E 5J1
Edmond Odette Cancer Centre at Sunnybrook
Toronto, Ontario, Canada, M4N 3M5
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Windsor Regional Cancer Centre at Windsor Regional Hospital
Windsor, Ontario, Canada, N8W 2X3
Canada, Quebec
Hopital Charles Lemoyne
Greenfield Park, Quebec, Canada, J4V 2H1
CHUM - Hotel Dieu Hospital
Montreal, Quebec, Canada, H2L-4M1
Maisonneuve-Rosemont Hospital
Montreal, Quebec, Canada, H1T 2M4
McGill Cancer Centre at McGill University
Montreal, Quebec, Canada, H2W 1S6
Hopital Notre-Dame du CHUM
Montreal, Quebec, Canada, H2L 4M1
Centre Hospitalier Universitaire de Quebec
Quebec City, Quebec, Canada, G1R 2J6
Hopital du Saint-Sacrement - Quebec
Quebec City, Quebec, Canada, G1S 4L8
Canada, Saskatchewan
Saskatoon Cancer Centre at the University of Saskatchewan
Saskatoon, Saskatchewan, Canada, S7N 4H4
Croatia
University Hospital Rebro
Zagreb, Croatia, 41000
Czech Republic
Thomayer's University Hospital
Prague, Czech Republic, 14000
France
Centre Hospitalier d'Annecy
Annecy, France, 74011 Cedex
Centre Hospitalier de la Cote Basque
Bayonne, France, 64100
Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz
Besancon, France, 25030
Institut Bergonie
Bordeaux, France, 33076
Polyclinique Bordeaux Nord Aquitaine
Boucher, France, 33300
C.H. Bourg En Bresse
Bourg En Bresse, France, 01012
CHU de Caen
Caen, France, 14033
Centre Regional Francois Baclesse
Caen, France, 14076
Polyclinique Du Parc
Caen, France, 14052
Centre Hospitalier Regional de Chambery
Chambery, France, 73011
Hopital Antoine Beclere
Clamart, France, 92141
Hopital d'Instruction des Armees Percy
Clamart, France, 92140
CHR Clermont Ferrand, Hotel Dieu
Clermont-Ferrand, France, 63003
Hopital Louis Pasteur
Colmar, France, 68024
Centre Hospitalier Sud Francilien - Site Corbeil
Corbeil, France, 91100
Centre Hospitalier Universitaire Henri Mondor
Creteil, France, 94010
Hopital Du Bocage
Dijon, France, 21034
Institut Prive de Cancerologie
Grenoble, France, 38100
Hopital Andre Mignot
Le Chesnay, France, 78157
Hopital Saint Antoine Lille
Lille, France, 59000
Centre Hospitalier Regional et Universitaire de Lille
Lille, France, 59037
Centre Hospital Regional Universitaire de Limoges
Limoges, France, 87042
Centre Leon Berard
Lyon, France, 69373
Hopital Edouard Herriot - Lyon
Lyon, France, 69437
Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes
Marseille, France, 13273
Centre Hospitalier de Meaux
Meaux, France, 77104
Centre Hospitalier Marc Jacquet
Melun, France, 77011
Hopital Notre-Dame de Bon Secours
Metz, France, 55038
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
Montpellier, France, 34298
Centre Hospitalier de Mulhouse
Mulhouse, France, 68051
Hopital de l'Archet CHU de Nice
Nice, France, F-06202
Centre Antoine Lacassagne
Nice, France, 06189
Hopital Cochin
Paris, France, 75674
Hopital Saint-Louis
Paris, France, 75475
Institut Curie Hopital
Paris, France, 75248
CHU Pitie-Salpetriere
Paris, France, 75651
Hopital Saint Antoine
Paris, France, 75571
Hopital Necker
Paris, France, 75743
Hotel Dieu de Paris
Paris, France, 75181
Hopital Haut Leveque
Pessac, France, 33604
Centre Hospitalier Lyon Sud
Pierre Benite, France, 69495
Hopital Rene Dubos
Pontoise, France, 95300
Institut Jean Godinot
Reims, France, 51056
Hopital Sud
Rennes, France, 35056
Centre Henri Becquerel
Rouen, France, 76038
Centre Rene Huguenin
Saint Cloud, France, 92211
CHU Sainte-Etienne - Hopital Bellevue
Saint Etienne, France, 42055
Hopital de Saint Germain-en-Laye
Saint Germain-en-Laye, France, 78104
Hopital Universitaire Hautepierre
Strasbourg, France, 67098
Hopital Foch
Suresnes, France, 92151
Centre Hospitalier Valence
Valence, France, 26000
Centre Hospitalier de Valenciennes
Valenciennes, France, 59300
CHU de Nancy - Hopitaux de Brabois
Vandoeuvre-Les-Nancy, France, 54511
Hopital Paul Brousse
Villejuif, France, 94804
Institut Gustave Roussy
Villejuif, France, F-94805
Hungary
National Institute of Oncology
Budapest, Hungary, 1122
Netherlands
HagaZiekenhuis - Locatie Leyenburg
's-Gravenhage, Netherlands, 2545 CH
Jeroen Bosch Ziekenhuis
's-Hertogenbosch, Netherlands, 5211 NL
Meander Medisch Centrum
Amersfoort, Netherlands, 3816 CP
Onze Lieve Vrouwe Gasthuis
Amsterdam, Netherlands, 1091 HA
Academisch Medisch Centrum at University of Amsterdam
Amsterdam, Netherlands, 1105 AZ
Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital
Amsterdam, Netherlands, 1066 CX
Reinier de Graaf Group - Delft
Delft, Netherlands, NL 2600 GA
Medisch Spectrum Twente
Enschede, Netherlands, 7500 KA
University Medical Center Groningen
Groningen, Netherlands, 9713 EZ
Atrium Medical Centre - Heerlen
Heerlen, Netherlands, 6419 PC
Leiden University Medical Center
Leiden, Netherlands, 2300 CA
Academisch Ziekenhuis Maastricht
Maastricht, Netherlands, 6202 AZ
Universitair Medisch Centrum St. Radboud - Nijmegen
Nijmegen, Netherlands, NL-6500 HB
Saint Laurentius Ziekenhuis
Roermond, Netherlands, 6043 CV
Daniel Den Hoed Cancer Center at Erasmus Medical Center
Rotterdam, Netherlands, 3008 AE
University Medical Center Utrecht
Utrecht, Netherlands, 3584 CX
New Zealand
Auckland City Hospital
Auckland, New Zealand, 1
Waikato Hospital
Hamilton, New Zealand, 2020
Poland
Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology - Warsaw
Warsaw, Poland, 02-781
Spain
Hospital Clinic de Barcelona
Barcelona, Spain, 08036
Hospital de la Santa Cruz i Sant Pau
Barcelona, Spain, 08025
Hospital Universitari Germans Trias i Pujol
Barcelona, Spain, 08916
Sweden
Sahlgrenska University Hospital
Gothenburg (Goteborg), Sweden, S-413 45
University Hospital of Linkoping
Linkoping, Sweden, S-581 85
Lund University Hospital
Lund, Sweden, S-22185
Karolinska University Hospital - Huddinge
Stockholm, Sweden, S-141 86
Umea Universitet
Umea, Sweden, S-901 85
Uppsala University Hospital
Uppsala, Sweden, S-75185
United Kingdom
Raigmore Hospital
Birmingham, England, United Kingdom, B15 2TH
Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust
Birmingham, England, United Kingdom, B15 2TH
Kent and Canterbury Hospital
Canterbury, England, United Kingdom, CT2 7NR
Hull Royal Infirmary
Hull, England, United Kingdom, HU3 2KZ
Kettering General Hosptial
Kettering, Northants, England, United Kingdom, NNI6 8UZ
Leicester Royal Infirmary
Leicester, England, United Kingdom, LE1 5WW
Middlesex Hospital
London, England, United Kingdom, WC1E 6HX
Mount Vernon Cancer Centre at Mount Vernon Hospital
Northwood, England, United Kingdom, HA6 2RN
Nottingham City Hospital NHS Trust
Nottingham, England, United Kingdom, NG5 1PB
Cancer Research Centre at Weston Park Hospital
Sheffield, England, United Kingdom, S1O 2SJ
Staffordshire General Hospital
Stafford, England, United Kingdom, ST16 3SA
Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
Lymphoma Trials Office
Lymphoma Study Association
Grup per l'Estudi dels Limfomes de Catalunya i Balears
NCIC Clinical Trials Group
Australasian Leukaemia and Lymphoma Group
Nordic Lymphoma Group
Investigators
Study Chair: Patrice P. Carde, MD Gustave Roussy, Cancer Campus, Grand Paris
Study Chair: David C. Linch Middlesex Hospital
Study Chair: Marine Divine, MD Centre Hospitalier Universitaire Henri Mondor
Study Chair: Anna Sureda Hospital de la Santa Cruz i Sant Pau
Study Chair: Ralph M. Meyer, MD, FRCPC Margaret and Charles Juravinski Cancer Centre
Study Chair: David Ma, MD St. Vincent’s Hospital.
Study Chair: Devinder Gill, MD Princess Alexandra Hospital
Study Chair: Bengt Glimelius, MD Uppsala University Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier: NCT00049595     History of Changes
Other Study ID Numbers: EORTC-20012, EORTC-20012, GELA-EORTC-20012, BNLI-EORTC-20012, GELCAB-EORTC-20012, NORDICLG-EORTC-20012, CAN-NCIC-EORTC-20012, ALLG-HD04, 2004-001558-10
Study First Received: November 12, 2002
Last Updated: June 13, 2014
Health Authority: United States: Federal Government

Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
adult lymphocyte depletion Hodgkin lymphoma
adult mixed cellularity Hodgkin lymphoma
adult nodular sclerosis Hodgkin lymphoma
stage III adult Hodgkin lymphoma
stage IV adult Hodgkin lymphoma

Additional relevant MeSH terms:
Lymphoma
Hodgkin Disease
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Cyclophosphamide
Liposomal doxorubicin
Doxorubicin
Vincristine
Vinblastine
Procarbazine
Bleomycin
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on September 18, 2014