Clinical Trial: High-Dose Chemotherapy Compared With Standard Chemotherapy in Treating Patients With Stage III or Stage IV Ovarian Epithelial Cancer That Has Been Removed During Surgery

This study is currently recruiting patients.

Sponsored by: EBMT Solid Tumors Working Party
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 most effective for ovarian epithelial cancer.

PURPOSE: This randomized phase III trial is studying high-dose chemotherapy to see how well it works compared to standard chemotherapy in treating patients with stage III or stage IV ovarian epithelial cancer that has been removed during surgery.

Condition Treatment or Intervention Phase
stage III ovarian epithelial cancer
stage IV ovarian epithelial cancer
 Drug: carboplatin
 Drug: cyclophosphamide
 Drug: filgrastim
 Drug: melphalan
 Drug: paclitaxel
 Procedure: adjuvant therapy
 Procedure: biological response modifier therapy
 Procedure: bone marrow ablation with stem cell support
 Procedure: chemotherapy
 Procedure: colony-stimulating factor therapy
 Procedure: cytokine therapy
 Procedure: high-dose chemotherapy
 Procedure: peripheral blood stem cell transplantation
Phase III

MedlinePlus related topics:  Ovarian Cancer

Study Type: Interventional
Study Design: Treatment

Official Title: Phase III Randomized Study of High-Dose Sequential Chemotherapy Versus Standard Chemotherapy in Patients With Optimally Debulked Stage III or IV Ovarian Epithelial Cancer

Further Study Details: 

OBJECTIVES:

OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.

  • Patients receive 5 courses of sequential high-dose chemotherapy as follows:
  • Courses 1 and 2: Patients receive paclitaxel IV over 3 hours and cyclophosphamide IV over 2 hours on day 1 followed by peripheral blood stem cell (PBSC) collection. Patients receive filgrastim (G-CSF) subcutaneously (SC) beginning 24 hours following chemotherapy and continuing until target number of PBSC are reached.
  • Courses 3 and 4: Patients receive paclitaxel as in courses 1-2 and carboplatin IV over 4 hours on day 1. At 72 hours following completion of carboplatin, patients receive PBSC infusion. Beginning one day following PBSC infusion, patients receive G-CSF SC until blood counts recover.
  • Course 5: Patients receive paclitaxel as in courses 1 and 2 and carboplatin as in courses 3 and 4 and melphalan IV over 15 minutes on day 2 or 3. Patients receive PBSC and G-CSF as in courses 3 and 4.
  • Treatment repeats every 3-4 weeks.
  • Arm II: Patients receive standard chemotherapy consisting of carboplatin (or cisplatin) and paclitaxel IV over 3 hours every 3 weeks for 6 courses. Patients may receive doxorubicin or epirubicin in addition to the standard chemotherapy every 4 weeks. Quality of life is assessed prior to therapy, at 4-6 weeks following completion of therapy, and then at 3 months, 9 months, and 15 months.

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

PROJECTED ACCRUAL: A total of 208 patients (104 per treatment arm) will be accrued for this study.

Eligibility

Ages Eligible for Study:  18 Years   -   65 Years,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

PATIENT CHARACTERISTICS: Age:

  • 18 to 65

Performance status:

  • ECOG 0-2

Life expectancy:

  • Not specified

Hematopoietic:

  • Normal hematological function

Hepatic:

Renal:

  • Creatinine clearance greater than 60 mL/min
  • GFR greater than 60 mL/min

Cardiovascular:

Other:

PRIOR CONCURRENT THERAPY: Biologic therapy

  • Not specified

Chemotherapy

  • No prior chemotherapy

Endocrine therapy

  • Not specified

Radiotherapy

  • Not specified

Surgery

  • See Disease Characteristics

Location and Contact Information


Austria
      Sozialmedizinisches Zentrum Ost - Donauspital, Vienna,  A-1220,  Austria; Recruiting
R Ruckser, MD  43-1-288-2-0000    dr.reinhard.ruckser@aon.at 

Belgium
      Centre Hospitalier Notre Dame - Reine Fabiola, Charleroi,  6000,  Belgium; Recruiting
Jean-Luc Canon, MD  32-71-281666 

Czech Republic
      Charles University, Prague 10,  10034,  Czech Republic; Recruiting
T. Kozak, MD, PhD  420-2-6716-2292    kozak@fnkv.cz 

      Thomayer Memorial Teaching Hospital, PRAGUE 4,  14000,  Czech Republic; Recruiting
J Nepomuca, MD  420-2-422-4701    onkolog@volny.cz 

Germany
      Klinikum Nuernberg - Klinikum Nord, Nuernberg,  D-90419,  Germany; Recruiting
Hannes Wandt, MD  49-911-398-3060    wandt@klinikum-nuernberg.de 

      Staedt Klinikum Karlsruhe GGMBH, Karlsruhe,  76133,  Germany; Recruiting
Joerg Th Fischer, MD  49-721-974-3001    haematologie@klinikum-karlsruhe.de 

Italy
      Azienda Ospedaliera Di Bologna Policlinico S. Orsola - Malpighi, Bologna,  40138,  Italy; Recruiting
C Zamagni, MD  39-051-636-2206 

      Ospedale San Bortolo, Vicenza,  36100,  Italy; Recruiting
Laura Merlini, MD  39-0444-993-906    la.merlini@libero.it 

      Ospedale Santa Chiara, Pisa,  56100,  Italy; Recruiting
C Bengala, MD  39-050-992929    c.bengala@med.unipi.it 

      S. Camillo Hospital, Rome,  00152,  Italy; Recruiting
L De Rosal, MD  +39-0658704301    l.derosa@tin.it 

Slovakia
      National Cancer Institute - Bratislava, Bratislava,  833 10,  Slovakia; Recruiting
J. Lakota, PhD  00421-25937811    lakota@ba.sanet.sk 

Spain
      Hospital Clinico Universitario de Valencia, Valencia,  46010,  Spain; Recruiting
Javier Garcia-Conde, MD  34-96-386-2625    garciaco@uv.es 

      Hospital Universitario San Carlos, Madrid,  28040,  Spain; Recruiting
Antonio Casado Herraez, MD  34-91-330-3000 ext. 7551 

Switzerland
      Centre Hospitalier Universitaire Vaudois, Lausanne,  CH-1011,  Switzerland; Recruiting
Jean A. Bauer, MD  41-21-314-0169    jean.bauer@chuv.hospvd.ch 

United Kingdom, England
      Cancer Research Centre at Weston Park Hospital, Manchester,  England,  M20 9BX,  United Kingdom; Recruiting
Paul C. Lorigan, MD  44-161-446-3000    paul.lorigan@man.ac.uk 

      Cancer Research UK and University College London Cancer Trials Centre, London,  England,  NW1 2ND,  United Kingdom; Recruiting
Jonathan A. Ledermann, MD  44-20-7679-8040    j.ledermann@ctc.ucl.ac.uk 

      St. James's University Hospital at Leeds Teaching Hospital NHS Trust, Leeds,  England,  LS9 7TF,  United Kingdom; Recruiting
Tim J. Perren, MD  44-113-206-4670    t.j.perren@leeds.ac.uk 

Study chairs or principal investigators

Jonathan A. Ledermann, MD,  Study Chair,  Cancer Research UK   

More Information

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

Study ID Numbers:  CDR0000067604; EBMT-HIDOC-EIS; EBMT-OVCAT; EU-99040; NCT00004921
Record last reviewed:  October 2003
Last Updated:  April 4, 2005
Record first received:  March 7, 2000
ClinicalTrials.gov Identifier:  NCT00004921
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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