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Combination Chemotherapy in Treating Patients With Advanced Hodgkin's Disease - Article


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Celiac Disease

Celiac Disease (Celiac Sprue); Celiac sprue


Clinical Trial: Combination Chemotherapy in Treating Patients With Advanced Hodgkin's Disease

This study is no longer recruiting patients.

Sponsored by: Medical Research Council
Information provided by: National Cancer Institute (NCI)

Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which chemotherapy regimen is more effective for advanced Hodgkin's disease. PURPOSE: Randomized phase III trial to compare different combination chemotherapy regimens in treating patients with advanced Hodgkin's disease.

Condition Treatment or Intervention Phase
stage II adult Hodgkin's disease
stage III adult Hodgkin's disease
stage IV adult Hodgkin's disease
stage I adult Hodgkin's disease
 Drug: bleomycin
 Drug: chlorambucil
 Drug: dacarbazine
 Drug: doxorubicin
 Drug: etoposide
 Drug: prednisolone
 Drug: procarbazine
 Drug: vinblastine
 Drug: vincristine
Phase III

MedlinePlus related topics:  Hodgkin's Disease

Study Type: Interventional
Study Design: Treatment

Official Title: Phase III Randomized Study of a Four-Drug Anthracycline Based Regimen or a Seven-Drug Hybrid or Eight-Drug Alternating Regimen in Patients with Advanced Hodgkin's Disease

Further Study Details: 

Study start: June 1998

OBJECTIVES: I. Determine whether a four-drug anthracycline based regimen or a seven-drug hybrid or eight-drug alternating regimen is the optimal treatment for patients with advanced Hodgkin's disease.

PROTOCOL OUTLINE: This is a randomized study. Patients are randomized to one of two treatment arms. Arm I (ABVD): Patients receive doxorubicin IV, bleomycin IV, vinblastine IV, and dacarbazine IV on days 1 and 15 of each 4 week course. Arm II (ChlVPP/PABLOE): Patients receive oral chlorambucil, procarbazine, and prednisolone on days 1-14; vinblastine IV on days 1 and 8; doxorubicin IV on day 29; vincristine IV and bleomycin IV on days 29 and 36; oral etoposide on days 29-31; and oral prednisolone again on days 29-38. Courses repeat every 7 weeks. OR (Hybrid - ChlVPP/EVA): Patients receive vincristine IV on day 1; oral etoposide on days 1-5; oral chlorambucil, procarbazine, and prednisolone on days 1-7; and doxorubicin IV and vinblastine IV on day 8. Courses repeat every 4 weeks. Patients in both arms receive up to 6-8 courses of treatment. Radiotherapy may be given to sites of previous bulk disease for patients in complete remission or uncertain remission. Patients who achieve partial remission may receive radiotherapy to residual disease sites. Patients who fail to respond, or have disease progression, may receive induction therapy followed by high dose consolidation therapy. Patients are followed every 3 months for 2 years, every 6 months for 5 years, and then annually for 5 years.

PROJECTED ACCRUAL: Approximately 200-800 patients will be accrued for this study.

Eligibility

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

  • Histologically confirmed advanced Hodgkin's disease requiring systemic therapy; Stage IA or IIA disease with bulky disease or more than three sites of involvement are also eligible

--Prior/Concurrent Therapy--

  • Biologic therapy: Not specified
  • Chemotherapy: No prior chemotherapy for Hodgkin's disease
  • Endocrine therapy: Not specified
  • Radiotherapy: No prior radiotherapy for Hodgkin's disease
  • Surgery: Not specified

--Patient Characteristics--

  • Age: Not specified
  • Performance status: Not specified
  • Hematopoietic: Not specified
  • Hepatic: Not specified
  • Renal: Not specified
  • Other: No other active malignancy within 5 years; Not HIV positive; Not pregnant or nursing; Fertile patients must use effective contraception

Location Information


United Kingdom, England
      St. James's Hospital, Leeds,  England,  LS9 7TF,  United Kingdom

      Weston Park Hospital, Sheffield,  England,  S1O 2SJ,  United Kingdom

Study chairs or principal investigators

B.W. Hancock,  Study Chair,  Medical Research Council   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000066441; MRC-UKLG-LY09; EU-98020
Record last reviewed:  March 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003421
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 8, 2005


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Page Updated: October 3, 2005
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