Comparison of Two Combination Chemotherapy Regimens in Treating Patients With Stage III or Stage IV Hodgkin's Lymphoma
The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by National Cancer Institute (NCI).
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
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:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00049595
First received: November 12, 2002
Last updated: November 2, 2010
Last verified: June 2009
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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 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:
Drug Information available for:
Cyclophosphamide
Prednisone
Vinblastine sulfate
Procarbazine hydrochloride
Procarbazine
Vinblastine
Vincristine sulfate
Dacarbazine
Bleomycin sulfate
Bleomycin
Sulfate ion
Doxorubicin
Doxorubicin hydrochloride
Etoposide
Etoposide phosphate
Filgrastim
Lenograstim
Granulocyte colony-stimulating factor
Pegfilgrastim
U.S. FDA Resources
Further study details as provided by National Cancer Institute (NCI):
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 ]
| Estimated Enrollment: | 550 |
| Study Start Date: | August 2002 |
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00049595
Show 140 Study Locations
Show 140 Study LocationsSponsors 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
| Investigator: | Patrice P. Carde, MD | Institut Gustave Roussy |
| 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 |
| Investigator: | David Ma, MD | St. Vincent’s Hospital. |
| Investigator: | Devinder Gill, MD | Princess Alexandra Hospital |
| Study Chair: | Bengt Glimelius, MD | Uppsala University Hospital |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00049595 History of Changes |
| Other Study ID Numbers: | CDR0000258125, EORTC-20012, GELA-EORTC-20012, BNLI-EORTC-20012, GELCAB-EORTC-20012, NORDICLG-EORTC-20012, CAN-NCIC-EORTC-20012, ALLG-HD04 |
| Study First Received: | November 12, 2002 |
| Last Updated: | November 2, 2010 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
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:
|
Hodgkin Disease Lymphoma Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Bleomycin Doxorubicin Cyclophosphamide Dacarbazine Etoposide Prednisone Procarbazine |
Vinblastine Vincristine Lenograstim Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Myeloablative Agonists |
ClinicalTrials.gov processed this record on May 16, 2013