Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| EBMT-HIDOC-EIS | |||
| EBMT-OVCAT | |||
| EU-99040 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
OBJECTIVES:
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:
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| filgrastim | Biological | |||
| carboplatin | Drug | |||
| cyclophosphamide | Drug | |||
| melphalan | Drug | |||
| paclitaxel | Drug | |||
| adjuvant therapy | Procedure | |||
| bone marrow ablation with stem cell support | Procedure | |||
DISEASE CHARACTERISTICS:
Histologically confirmed stage III or IV ovarian epithelial cancer
Bilateral salpingo-oophorectomy, hysterectomy, and omentectomy within 6 weeks of study
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jonathan A. Ledermann, MD | Cancer Research UK | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sozialmedizinisches Zentrum Ost - Donauspital | Vienna | A-1220 | Austria | |||
| Centre Hospitalier Notre Dame - Reine Fabiola |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17698804 | Result | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| peripheral blood stem cell transplantation |
| Procedure |
| Charleroi |
| 6000 |
| Belgium |
| Charles University | Prague | 10034 | Czechia |
| Thomayer Memorial Teaching Hospital | Prague | 14000 | Czechia |
| Staedt Klinikum Karlsruhe GGMBH | Karlsruhe | 76133 | Germany |
| Klinikum Nuernberg - Klinikum Nord | Nuremberg | D-90419 | Germany |
| Azienda Ospedaliera Di Bologna Policlinico S. Orsola - Malpighi | Bologna | 40138 | Italy |
| Ospedale Santa Chiara | Pisa | 56100 | Italy |
| S. Camillo Hospital | Rome | 00152 | Italy |
| Ospedale San Bortolo | Vicenza | 36100 | Italy |
| National Cancer Institute - Bratislava | Bratislava | 833 10 | Slovakia |
| Hospital Universitario San Carlos | Madrid | 28040 | Spain |
| Hospital Clinico Universitario de Valencia | Valencia | 46010 | Spain |
| Centre Hospitalier Universitaire Vaudois | Lausanne | CH-1011 | Switzerland |
| Leeds Cancer Centre at St. James's University Hospital | Leeds | England | LS9 7TF | United Kingdom |
| Cancer Research UK and University College London Cancer Trials Centre | London | England | NW1 2ND | United Kingdom |
| Cancer Research Centre at Weston Park Hospital | Manchester | England | M20 9BX | United Kingdom |
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| D000077216 | Carcinoma, Ovarian Epithelial |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069585 | Filgrastim |
| D016190 | Carboplatin |
| D003520 | Cyclophosphamide |
| D008558 | Melphalan |
| D017239 | Paclitaxel |
| D017024 | Chemotherapy, Adjuvant |
| D036102 | Peripheral Blood Stem Cell Transplantation |
| ID | Term |
|---|---|
| D016179 | Granulocyte Colony-Stimulating Factor |
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D016298 | Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D010649 | Phenylalanine |
| D024322 | Amino Acids, Aromatic |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
| D018380 | Hematopoietic Stem Cell Transplantation |
| D033581 | Stem Cell Transplantation |
| D017690 | Cell Transplantation |
| D064987 | Cell- and Tissue-Based Therapy |
| D001691 | Biological Therapy |
| D014180 | Transplantation |
| D013514 | Surgical Procedures, Operative |
Not provided
Not provided