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
NCT ID: NCT00004921
Last Updated: 2013-09-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
INTERVENTIONAL
1998-09-30
2007-09-30
Brief Summary
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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.
Detailed Description
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* 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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
TREATMENT
Interventions
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filgrastim
carboplatin
cyclophosphamide
melphalan
paclitaxel
adjuvant therapy
bone marrow ablation with stem cell support
peripheral blood stem cell transplantation
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
65 Years
FEMALE
No
Sponsors
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EBMT Solid Tumors Working Party
OTHER
Principal Investigators
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Jonathan A. Ledermann, MD
Role: STUDY_CHAIR
Cancer Research UK
Locations
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Sozialmedizinisches Zentrum Ost - Donauspital
Vienna, , Austria
Centre Hospitalier Notre Dame - Reine Fabiola
Charleroi, , Belgium
Charles University
Prague, , Czechia
Thomayer Memorial Teaching Hospital
Prague, , Czechia
Staedt Klinikum Karlsruhe GGMBH
Karlsruhe, , Germany
Klinikum Nuernberg - Klinikum Nord
Nuremberg, , Germany
Azienda Ospedaliera Di Bologna Policlinico S. Orsola - Malpighi
Bologna, , Italy
Ospedale Santa Chiara
Pisa, , Italy
S. Camillo Hospital
Rome, , Italy
Ospedale San Bortolo
Vicenza, , Italy
National Cancer Institute - Bratislava
Bratislava, , Slovakia
Hospital Universitario San Carlos
Madrid, , Spain
Hospital Clinico Universitario de Valencia
Valencia, , Spain
Centre Hospitalier Universitaire Vaudois
Lausanne, , Switzerland
Leeds Cancer Centre at St. James's University Hospital
Leeds, England, United Kingdom
Cancer Research UK and University College London Cancer Trials Centre
London, England, United Kingdom
Cancer Research Centre at Weston Park Hospital
Manchester, England, United Kingdom
Countries
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References
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Mobus V, Wandt H, Frickhofen N, Bengala C, Champion K, Kimmig R, Ostermann H, Hinke A, Ledermann JA; AGO-Ovar/AIO; EBMT. Phase III trial of high-dose sequential chemotherapy with peripheral blood stem cell support compared with standard dose chemotherapy for first-line treatment of advanced ovarian cancer: intergroup trial of the AGO-Ovar/AIO and EBMT. J Clin Oncol. 2007 Sep 20;25(27):4187-93. doi: 10.1200/JCO.2006.09.7527. Epub 2007 Aug 13.
Other Identifiers
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EBMT-HIDOC-EIS
Identifier Type: -
Identifier Source: secondary_id
EBMT-OVCAT
Identifier Type: -
Identifier Source: secondary_id
EU-99040
Identifier Type: -
Identifier Source: secondary_id
CDR0000067604
Identifier Type: -
Identifier Source: org_study_id