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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00004921
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : September 17, 2013
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

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 or disease Intervention/treatment Phase
Ovarian Cancer Biological: filgrastim Drug: carboplatin Drug: cyclophosphamide Drug: melphalan Drug: paclitaxel Procedure: adjuvant therapy Procedure: bone marrow ablation with stem cell support Procedure: peripheral blood stem cell transplantation Phase 3

Detailed Description:


  • Compare the two-year progression-free survival in patients with optimally debulked stage III or IV ovarian epithelial cancer undergoing high-dose sequential chemotherapy vs standard chemotherapy.
  • Compare the overall survival, toxicity, and quality of life in this patient population receiving these two treatment regimens.

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

  • Arm I: 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.

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Primary Purpose: Treatment
Official Title: A Randomized Phase III Trial of Sequential High Dose Chemotherapy or Standard Chemotherapy for Optimally Debulked FIGO Stage III and IV Ovarian Cancer
Study Start Date : September 1998
Actual Study Completion Date : September 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer
U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • Histologically confirmed stage III or IV ovarian epithelial cancer
  • Bilateral salpingo-oophorectomy, hysterectomy, and omentectomy within 6 weeks of study

    • Less than 2 cm maximum diameter of residual tumor remaining



  • 18 to 65

Performance status:

  • ECOG 0-2

Life expectancy:

  • Not specified


  • Normal hematological function


  • Normal hepatic function


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


  • No active cardiac disease


  • No other uncontrolled serious medical illness, including hearing problems
  • No other malignancy within the past 5 years except basal cell skin cancer or carcinoma in situ of the cervix


Biologic therapy

  • Not specified


  • No prior chemotherapy

Endocrine therapy

  • Not specified


  • Not specified


  • See Disease Characteristics

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00004921

Sozialmedizinisches Zentrum Ost - Donauspital
Vienna, Austria, A-1220
Centre Hospitalier Notre Dame - Reine Fabiola
Charleroi, Belgium, 6000
Czech Republic
Charles University
Prague 10, Czech Republic, 10034
Thomayer Memorial Teaching Hospital
Prague 4, Czech Republic, 14000
Staedt Klinikum Karlsruhe GGMBH
Karlsruhe, Germany, 76133
Klinikum Nuernberg - Klinikum Nord
Nuernberg, Germany, D-90419
Azienda Ospedaliera Di Bologna Policlinico S. Orsola - Malpighi
Bologna, Italy, 40138
Ospedale Santa Chiara
Pisa, Italy, 56100
S. Camillo Hospital
Rome, Italy, 00152
Ospedale San Bortolo
Vicenza, Italy, 36100
National Cancer Institute - Bratislava
Bratislava, Slovakia, 833 10
Hospital Universitario San Carlos
Madrid, Spain, 28040
Hospital Clinico Universitario de Valencia
Valencia, Spain, 46010
Centre Hospitalier Universitaire Vaudois
Lausanne, Switzerland, CH-1011
United Kingdom
Leeds Cancer Centre at St. James's University Hospital
Leeds, England, United Kingdom, LS9 7TF
Cancer Research UK and University College London Cancer Trials Centre
London, England, United Kingdom, NW1 2ND
Cancer Research Centre at Weston Park Hospital
Manchester, England, United Kingdom, M20 9BX
Sponsors and Collaborators
EBMT Solid Tumors Working Party
Study Chair: Jonathan A. Ledermann, MD Cancer Research UK

Publications of Results: Identifier: NCT00004921     History of Changes
Other Study ID Numbers: CDR0000067604
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: September 17, 2013
Last Verified: July 2002

Keywords provided by National Cancer Institute (NCI):
stage III ovarian epithelial cancer
stage IV ovarian epithelial cancer

Additional relevant MeSH terms:
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists