- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00102375
Paclitaxel, Carboplatin, and Topotecan in Patients With Ovarian Cancer
Phase III Multicenter Study in Epithelial Ovarian Carcinoma FIGO Stage IIB-IV Comparing Treatment With Paclitaxel and Carboplatin to Paclitaxel and Carboplatin Sequentially Followed by Topotecan
Studieoversigt
Detaljeret beskrivelse
Carboplatin-Paclitaxel is the current standard in the first-line treatment of advanced ovarian cancer. One option to further improve the therapeutic results is the incorporation of a third, non-cross-resistant drug into first line chemotherapy of advanced ovarian cancer. In two separate, single center phase II studies, a different combination of the three active agents (Carboplatin, Paclitaxel and Topotecan) has been tested. In these studies, Carboplatin and Paclitaxel were given at standard doses and schedules, followed sequentially by Topotecan which was well tolerated at a dose of 1.25 mg/m2/day given for five days and repeated every 21 days. The prolonged therapy is not associated with cumulative toxicity and the compliance of the patients was good.
Study Hypothesis/Comparison: The triple combination (Carboplatin/Paclitaxel/Topotecan) yields superior outcome in the treatment of first-line ovarian cancer compared with the combination of Carboplatin + Paclitaxel
Undersøgelsestype
Tilmelding
Fase
- Fase 3
Kontakter og lokationer
Studiesteder
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Aachen, Tyskland, 52074
- Gynecologic Hospital of the Medical Facilities RWTH
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Berlin, Tyskland, 10117
- Clinic for Gynecology and Gyn. Oncology, Humboldt University
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Dresden, Tyskland, 01307
- University Clinic Carl Gustav Carus, Gynecological hospital
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Duesseldorf, Tyskland, 40217
- Gynecologic Hospital
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Duesseldorf, Tyskland, 40225
- University Gynecologic Hospital
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Frankfurt, Tyskland, 60596
- University Gynecologic Hospital
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Greifswald, Tyskland, 17487
- Gynecologic Clinic of the Ernst-Moritz-Arndt-University
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Göttingen, Tyskland, 37075
- University Gynecologic Hospital
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Hannover, Tyskland, 30659
- Gynecological Clinic of the Medical University
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Karlsruhe, Tyskland, 76137
- St. Vincentius Gynecologic Hospital
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Kiel, Tyskland, 24105
- University Clinic Schleswig-Holstein, Campus Kiel, Clinic for gynecology and obstetrics
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Magdeburg, Tyskland, 39108
- Otto-von-Guericke University, University Gynecological Hospital
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Muenchen, Tyskland, 81377
- University Gynecologic Hospital Grosshadern
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Muenchen, Tyskland, 81675
- University Gynecologic Hospital "rechts der Isar"
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Muenster, Tyskland, 48149
- Clinic for Gynecology
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Tuebingen, Tyskland, 72076
- University Gynecologic Hospital
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Ulm, Tyskland, 89075
- University Gynecological Hospital
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Wiesbaden, Tyskland, 65199
- Clinic for Gnyecology and gyn. Oncology HSK
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Histologically proven epithelial carcinoma of the ovary or of the fallopian tube or extraovarian papillary serous carcinoma with extent to the ovary
- International Federation of Gynecology and Obstetrics (FIGO) stage IIB-IV, regardless of measurable or non-measurable disease
- No prior chemo- or radiotherapy
Adequate hematologic, renal and hepatic function:
- ANC ≥ 1.5 x 10^9/L,
- Platelet counts ≥ 100 x 10^9/L,
- Total bilirubin ≤ 1.5 x upper normal limit,
- Alkaline Phosphatase ≤ 3 x upper normal limit,
- Serum creatinine ≤ 1.25 upper normal limit,
- Estimated GFR ≥ 60 ml/min
- Performance status 0-2 (ECOG)
- Life expectancy must be greater than 12 weeks
Exclusion Criteria:
- Non-epithelial tumors or mixed epithelial/non-epithelial tumors (e.g. mixed Mullerian tumors) or tumors of low malignant potential (borderline tumors)
- Prior treatment with chemo- or radiotherapy
- Administration of other simultaneous chemotherapeutic drugs or hormonal therapy or simultaneous radiotherapy during the study treatment period or planned whole abdominal radiotherapy
- History of congestive heart failure
- Symptomatic brain metastasis
- Complete bowel obstruction
- Dementia
- Active infection or other serious underlying medical condition
- Pre-existing motor or sensory neurologic pathology
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
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Overlevelse
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Sekundære resultatmål
Resultatmål |
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Svarprocent
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Progressionsfri overlevelse
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Livskvalitet
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Svarvarighed
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Toksiciteter
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Jacobus Pfisterer, Prof. Dr., AGO Study Group
Publikationer og nyttige links
Hjælpsomme links
Datoer for undersøgelser
Studer store datoer
Studiestart
Studieafslutning
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Neoplasmer efter histologisk type
- Neoplasmer
- Urogenitale neoplasmer
- Neoplasmer efter sted
- Karcinom
- Neoplasmer, kirtel og epitel
- Genitale neoplasmer, kvindelige
- Sygdomme i det endokrine system
- Ovariesygdomme
- Adnexale sygdomme
- Gonadale lidelser
- Neoplasmer i endokrine kirtler
- Ovariale neoplasmer
- Karcinom, ovarieepitel
- Molekylære mekanismer for farmakologisk virkning
- Enzymhæmmere
- Antineoplastiske midler
- Topoisomerasehæmmere
- Topoisomerase I-hæmmere
- Topotecan
Andre undersøgelses-id-numre
- AGO-OVAR 7
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