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 has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00004921
First received: March 7, 2000
Last updated: September 16, 2013
Last verified: July 2002
  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 Intervention 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

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: September 1998
Study Completion Date: September 2007
Detailed Description:

OBJECTIVES:

  • 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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age:

  • 18 to 65

Performance status:

  • ECOG 0-2

Life expectancy:

  • Not specified

Hematopoietic:

  • Normal hematological function

Hepatic:

  • Normal hepatic function

Renal:

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

Cardiovascular:

  • No active cardiac disease

Other:

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • No prior chemotherapy

Endocrine therapy

  • Not specified

Radiotherapy

  • Not specified

Surgery

  • See Disease Characteristics
  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: NCT00004921

Locations
Austria
Sozialmedizinisches Zentrum Ost - Donauspital
Vienna, Austria, A-1220
Belgium
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
Germany
Staedt Klinikum Karlsruhe GGMBH
Karlsruhe, Germany, 76133
Klinikum Nuernberg - Klinikum Nord
Nuernberg, Germany, D-90419
Italy
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
Slovakia
National Cancer Institute - Bratislava
Bratislava, Slovakia, 833 10
Spain
Hospital Universitario San Carlos
Madrid, Spain, 28040
Hospital Clinico Universitario de Valencia
Valencia, Spain, 46010
Switzerland
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
Investigators
Study Chair: Jonathan A. Ledermann, MD Cancer Research UK
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00004921     History of Changes
Other Study ID Numbers: CDR0000067604, EBMT-HIDOC-EIS, EBMT-OVCAT, EU-99040
Study First Received: March 7, 2000
Last Updated: September 16, 2013
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Ovarian Neoplasms
Neoplasms, Glandular and Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Neoplasms by Histologic Type
Cyclophosphamide
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

ClinicalTrials.gov processed this record on September 30, 2014