- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00006454
Paclitaxel Plus Carboplatin With or Without Topotecan in Treating Patients With Stage IIB, Stage III, or Stage IV Ovarian Epithelial 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
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 if paclitaxel plus carboplatin is more effective with or without topotecan for ovarian epithelial cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of paclitaxel plus carboplatin with or without topotecan in treating patients who have stage IIB, stage III, or stage IV ovarian epithelial cancer.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
OBJECTIVES: I. Compare survival of patients with stage IIB, III, or IV ovarian epithelial carcinoma after receiving treatment with paclitaxel and carboplatin with or without topotecan. II. Compare progression-free survival of these patients after receiving these treatment regimens. III. Compare the response rate and response duration in these patients treated with these regimens. IV. Determine the toxic effects of the combination of paclitaxel, carboplatin, and topotecan in these patients. V. Compare the toxic effects of these treatment regimens in these patients. VI. Compare quality of life of these patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center and stage (stage IIB and stage III optimally debulked to no greater than 1 cm residual tumor vs stage IV regardless of residual tumor or residual tumor greater than 1 cm). Patients are randomized to one of two treatment arms. Arm I: Patients receive paclitaxel IV over 3 hours and carboplatin IV over 0.5-1 hour on day 1 and topotecan IV over 0.5 hour on days 1-5. Treatment repeats every 21 days for 6 courses (topotecan is administered for 4 courses only). Arm II: Patients receive paclitaxel and carboplatin as in arm I. Treatment repeats every 21 days for 6 courses. Quality of life is assessed before courses 1, 3, and 5 and at 3 weeks and 3 months after completion of treatment in both treatment arms; before courses 1 and 3 of topotecan in arm I; and at 6 months after completion of treatment in arm II. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 914 patients (457 per treatment arm) will be accrued for this study over 2 years.
Studietyp
Fas
- Fas 3
Kontakter och platser
Studieorter
-
-
-
Berlin, Tyskland, D-10117
- Universitaetsklinikum Charite
-
Bonn, Tyskland, D-53105
- Universitaetskliniken Bonn
-
Bremen, Tyskland, D-28205
- Zentralkrankenhaus
-
Dresden, Tyskland, D-01307
- Medizinische Klinik I
-
Duesseldorf, Tyskland, D-40225
- Universitaetsklinik Duesseldorf
-
Dusseldorf, Tyskland, DOH-4-0217
- Evangelisches Krankenhaus
-
Frankfurt, Tyskland, D-60590
- Klinikum der J.W. Goethe Universitaet
-
Frankfurt, Tyskland, DOH-6-5929
- Stadtische Kliniken Frankfurt-Hochst
-
Gottingen, Tyskland, D-37075
- Universitaetsklinik Goettingen
-
Greifswald, Tyskland, D-17487
- Klinik Fuer Innere Medizin Hematology/Oncology, Ernst Moritz Armdt Universitaet
-
Hannover, Tyskland, 30659
- Frauenklinik der MHH
-
Karlsruhe, Tyskland, D-76137
- Vincentius Krankenhaus
-
Kiel, Tyskland, D-24105
- Christian-Albrechts University of Kiel
-
Magdeburg, Tyskland, 39108
- Klinik der Otto-v.-Guericke-Universitat
-
Muenster, Tyskland, D-48129
- Klinik und Poliklinik fuer Kinderheilkunde
-
Munich, Tyskland, D-81377
- Klinikum Großhadern
-
Munich, Tyskland, D-81675
- Klinikum Rechts Der Isar/Technische Universitaet Muenchen
-
Tuebingen, Tyskland, D-72076
- Universitaetsklinikum Tuebingen
-
Wiesbaden, Tyskland, D-65199
- Dr. Horst-Schmidt-Kliniken
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
DISEASE CHARACTERISTICS: Histologically confirmed stage IIB, III, or IV ovarian epithelial carcinoma, fallopian tube, or extraovarian papillary serous carcinoma extending to the ovary No mixed epithelial/non-epithelial tumors (e.g., mixed Mullerian tumors) No tumors of low malignant potential (e.g., borderline tumors) No symptomatic brain metastases
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 OR Karnofsky 70-100% Life expectancy: More than 12 weeks Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times the upper limit of normal (ULN) Alkaline phosphatase no greater than 3 times ULN Renal: Creatinine no greater than 1.25 times ULN Estimated glomerular filtration rate at least 60 mL/min Cardiovascular: No history of congestive heart failure (even if medically controlled) No New York Heart Association class III or IV heart disease No myocardial infarction within the past 6 months No history of atrial or ventricular arrhythmias Other: No motor or sensory neurologic pathology or symptoms greater than grade 1 No active infection or other serious medical condition that would preclude study No prior allergy to drug containing Cremophor EL No dementia or significantly altered mental state that would preclude informed consent No complete bowel obstruction No other prior malignancy except curatively treated nonmelanomatous skin cancer or carcinoma in situ of the cervix Not pregnant or nursing Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent immunotherapy No concurrent WBC transfusions Chemotherapy: No prior chemotherapy No other concurrent chemotherapy Endocrine therapy: No concurrent hormonal therapy Radiotherapy: No prior radiotherapy No concurrent radiotherapy Surgery: No more than 6 weeks since prior definitive laparotomy and recovered Other: No other concurrent antineoplastic agents No other concurrent investigational drugs
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
Samarbetspartners och utredare
Sponsor
Utredare
- Studiestol: Jacobus Pfisterer, MD, University Hospital Schleswig-Holstein
Publikationer och användbara länkar
Allmänna publikationer
- Pfisterer J, Weber B, Reuss A, Kimmig R, du Bois A, Wagner U, Bourgeois H, Meier W, Costa S, Blohmer JU, Lortholary A, Olbricht S, Stahle A, Jackisch C, Hardy-Bessard AC, Mobus V, Quaas J, Richter B, Schroder W, Geay JF, Luck HJ, Kuhn W, Meden H, Nitz U, Pujade-Lauraine E; AGO-OVAR; GINECO. Randomized phase III trial of topotecan following carboplatin and paclitaxel in first-line treatment of advanced ovarian cancer: a gynecologic cancer intergroup trial of the AGO-OVAR and GINECO. J Natl Cancer Inst. 2006 Aug 2;98(15):1036-45. doi: 10.1093/jnci/djj296.
- Greimel ER, Bjelic-Radisic V, Pfisterer J, Hilpert F, Daghofer F, Pujade-Lauraine E, du Bois A; Arbeitsgemeinschaft Gynaekologische Onkologie Ovarian Cancer Study Group (AGO-OVAR); Groupe d'Investigateurs Nationaux pour les Etudes des Cancers de l'Ovaire (GINECO). Toxicity and quality of life outcomes in ovarian cancer patients participating in randomized controlled trials. Support Care Cancer. 2011 Sep;19(9):1421-7. doi: 10.1007/s00520-010-0969-8. Epub 2010 Aug 6.
- Pfisterer J, Lortholary A, Kimmig R, et al.: Paclitaxel/carboplatin (TC) vs. paclitaxel/carboplatin followed by topotecan (TC-Top) in first-line treatment of ovarian cancer FIGO stages IIb - IV. Interim results of a gynecologic cancer intergroup phase III trial of the AGO Ovarian Cancer Study Group and GINECO. [Abstract] Proceedings of the American Society of Clinical Oncology 22: A-1793, 446, 2003.
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Neoplasmer efter histologisk typ
- Neoplasmer
- Urogenitala neoplasmer
- Neoplasmer efter plats
- Carcinom
- Neoplasmer, körtel och epitel
- Genitala neoplasmer, hona
- Sjukdomar i det endokrina systemet
- Ovariella sjukdomar
- Adnexala sjukdomar
- Gonadal sjukdomar
- Neoplasmer i endokrina körtel
- Äggledarsjukdomar
- Ovariella neoplasmer
- Äggledarneoplasmer
- Karcinom, äggstocksepitel
- Molekylära mekanismer för farmakologisk verkan
- Enzyminhibitorer
- Antineoplastiska medel
- Tubulin modulatorer
- Antimitotiska medel
- Mitosmodulatorer
- Antineoplastiska medel, fytogena
- Topoisomerasinhibitorer
- Topoisomeras I-hämmare
- Karboplatin
- Paklitaxel
- Topotecan
Andra studie-ID-nummer
- CDR0000067994
- AGOSG-OVAR-7
- NCI-V00-1602
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
Kliniska prövningar på Äggstockscancer
-
Ann & Robert H Lurie Children's Hospital of ChicagoOkändCystektomi | Godartade cystor Ovarian | Torsion | Maligna cystor OvarianFörenta staterna
-
Assistance Publique - Hôpitaux de ParisAktiv, inte rekryterandeOkomplicerad Tubo Ovarian AbscessFrankrike
-
Peking University Third HospitalHar inte rekryterat ännuOvarian clear cell carcinoma
-
Dansk FertilitetsklinikOkändKvinnlig infertilitet | Hypogonadism; OvarianDanmark
-
University Health Network, TorontoAvslutad
-
AstraZenecaAvslutadOvarian, Äggledaren, Peritoneal cancer, P53 MutationFörenta staterna, Kanada, Nederländerna
-
M.D. Anderson Cancer CenterGSK Pharma; LixteRekryteringOvarian clear cell carcinomaFörenta staterna
-
National University Hospital, SingaporeOkändOvarian clear cell carcinomaSingapore
-
Tongji HospitalWuhan University; Henan Cancer Hospital; Qilu Hospital of Shandong University och andra samarbetspartnersRekryteringOvarian clear cell carcinomaKina
-
SpringWorks Therapeutics, Inc.Aktiv, inte rekryterandeÄggstockscancer | Ovarian granulosa celltumör | Ovarian Granulosa-Stromal tumörFörenta staterna, Kanada, Polen
Kliniska prövningar på karboplatin
-
Samyang Biopharmaceuticals CorporationAvslutad
-
AkesoRekryteringAvancerad skivepitelcancer, icke-småcellig lungcancerKina
-
Samyang Biopharmaceuticals CorporationAvslutad
-
Gynecologic Oncology Trial & Investigation ConsortiumJapanese Gynecologic Oncology GroupAvslutadÄggledarcancer | Epitelial äggstockscancer | Primärt peritonealt karcinomJapan, Förenta staterna, Hong Kong, Korea, Republiken av, Nya Zeeland, Singapore
-
Myrexis Inc.OkändGlioblastoma MultiformeFörenta staterna
-
The First Affiliated Hospital of Guangzhou Medical...Okänd
-
National Cancer Institute (NCI)AvslutadBröstcancer | ÄggstockscancerFörenta staterna
-
Rennes University HospitalAvslutadÄggstockscancerFrankrike
-
Sharon SteinMerck Sharp & Dohme LLCAvslutad
-
Konstantin DragnevAbbottAvslutadLungcancer | Icke småcellig lungcancerFörenta staterna