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Sponsored by: |
EBMT Solid Tumors Working Party |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00004921 |
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 III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
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 |
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:
Patients receive PBSC and G-CSF as in courses 3 and 4.
Treatment repeats every 3-4 weeks.
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.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
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
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 | |
Klinikum Nuernberg - Klinikum Nord | |
Nuernberg, Germany, D-90419 | |
Staedt Klinikum Karlsruhe GGMBH | |
Karlsruhe, Germany, 76133 | |
Italy | |
Azienda Ospedaliera Di Bologna Policlinico S. Orsola - Malpighi | |
Bologna, Italy, 40138 | |
Ospedale San Bortolo | |
Vicenza, Italy, 36100 | |
Ospedale Santa Chiara | |
Pisa, Italy, 56100 | |
S. Camillo Hospital | |
Rome, Italy, 00152 | |
Slovakia | |
National Cancer Institute - Bratislava | |
Bratislava, Slovakia, 833 10 | |
Spain | |
Hospital Clinico Universitario de Valencia | |
Valencia, Spain, 46010 | |
Hospital Universitario San Carlos | |
Madrid, Spain, 28040 | |
Switzerland | |
Centre Hospitalier Universitaire Vaudois | |
Lausanne, Switzerland, CH-1011 | |
United Kingdom, England | |
Cancer Research Centre at Weston Park Hospital | |
Manchester, England, United Kingdom, M20 9BX | |
Cancer Research UK and University College London Cancer Trials Centre | |
London, England, United Kingdom, NW1 2ND | |
Leeds Cancer Centre at St. James's University Hospital | |
Leeds, England, United Kingdom, LS9 7TF |
Study Chair: | Jonathan A. Ledermann, MD | Cancer Research UK |
Study ID Numbers: | CDR0000067604, EBMT-HIDOC-EIS, EBMT-OVCAT, EU-99040 |
Study First Received: | March 7, 2000 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00004921 History of Changes |
Health Authority: | United States: Federal Government |
stage III ovarian epithelial cancer stage IV ovarian epithelial cancer |
Melphalan Ovarian Neoplasms Immunologic Factors Gonadal Disorders Adjuvants, Immunologic Genital Neoplasms, Female Endocrine System Diseases Urogenital Neoplasms Antimitotic Agents Carboplatin Ovarian Diseases Cyclophosphamide |
Ovarian Epithelial Cancer Immunosuppressive Agents Genital Diseases, Female Paclitaxel Tubulin Modulators Ovarian Cancer Antineoplastic Agents, Alkylating Endocrinopathy Antirheumatic Agents Antineoplastic Agents, Phytogenic Alkylating Agents Endocrine Gland Neoplasms |
Immunologic Factors Molecular Mechanisms of Pharmacological Action Gonadal Disorders Antineoplastic Agents Physiological Effects of Drugs Urogenital Neoplasms Cyclophosphamide Ovarian Diseases Genital Diseases, Female Neoplasms by Site Therapeutic Uses Alkylating Agents Endocrine Gland Neoplasms Ovarian Neoplasms Mitosis Modulators |
Genital Neoplasms, Female Endocrine System Diseases Antimitotic Agents Carboplatin Immunosuppressive Agents Pharmacologic Actions Adnexal Diseases Neoplasms Paclitaxel Tubulin Modulators Myeloablative Agonists Antineoplastic Agents, Alkylating Antirheumatic Agents Antineoplastic Agents, Phytogenic |