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Brief Title: Study of Paclitaxel in Patients With Ovarian Cancer
Official Title: An Open, Randomized, Multicenter Study in Patients With Recurrent Epithelian Cancer, Primary Peritoneal Cancer or Fallopian Tube Cancer to Compare the Efficay and Safety of Paclitaxel (Micellar) Nanoparticles and Paclitaxel (Cremophor® EL)
Study ID: NCT00989131
Brief Summary: RATIONALE: Paclitaxel is one of the most widely used human anticancer agents. Paclitaxel has a low degree of solubility and Cremophor EL is typically used as the solubiliser. Cremophor EL is known to cause hypersensitivity reactions that can be life-threatening. As Paclical® does not contain Cremophor EL, hypersensitivity reactions can be expected to be less. PURPOSE: To study the efficay and safety of two different formulations of paclitaxel, Paclical® and Taxol®.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Gomel Regional Clincial Oncology Center, Gomel, , Belarus
Minsk City Clinical Oncology Hospital, Minsk, , Belarus
Alexandrov National Cancer Center of Belarus, Minsk, , Belarus
Vitebsk Regional Clinical Oncology Center, Vitebsk, , Belarus
Department of gyneacology, Campus Gasthuisberg, Leuven, , Belgium
Regional Oncology Dispensary, Shumen, , Bulgaria
Hospital for a Active Treatment, Tsaritsa Yoanna, Sofia, , Bulgaria
Regional Oncology Dispensary, Stara Zagora, , Bulgaria
Klinički Bolnički Centar Rijeka, Rijeka, , Croatia
Klinički Bolnički Centar Split, Split, , Croatia
Klinikčki Bolnički Centar Zagreb, Zagreb, , Croatia
Onkologická klinika, Fakultní nemocnice Královské Vinohrady, Olomouc, , Czech Republic
Onkologické a radioterapeutické oddělení, Fakultní nemocnice Plzeň, Plzen, , Czech Republic
Radioterapeutická a onkologická klinika, Fakultní nemocnice Královské Vinohrady, Prague, , Czech Republic
Ústav radiační onkologie, Fakultní nemocnice Na Bulovce, Prague, , Czech Republic
Onkologisk Afdelning, Herning Sygehus, Herning, , Denmark
Kuopion Yliopistollinen Sairaala, Naisten Klinikka, Kuopio, , Finland
Turun Yliopistollinen Keskussairaala, Naisten Klinikka,, Turku, , Finland
Kaposi Mór Megyei Kórház, Onkológiai Tanszék, Kaposvár, , Hungary
B.-A.-Z. Megyei Kórház és Egyetemi Oktató Kórház, Észak-Kelet Magyarországi Regionális Klinikai Farmakológiai Központ, Miskolc, , Hungary
Szabolcs-Szatmár-Bereg Megyei Önkormányzat Jósa András Oktató Kórháza, Onkoradiológia, Nyíregyháza, , Hungary
Veszprém Megyei Csolnoky Ferenc Kórház-Rendelőintézet ZRT, Veszprém, , Hungary
Zala Megyei Kórház, Onkológia, Zalaegerszeg, , Hungary
Latvian Oncology Center of Riga Easter Hospital Ltd, Riga, , Latvia
Kaunas Medical University Hospital, Oncology Clinic, Kaunas, , Lithuania
Institute of Oncology, Vilnius University, Vilnius, , Lithuania
County Clinical Emergency Hospital Oradea, Oradea, Bihor County, Romania
MEDITECH SRL, ORIZONT Polyclinic, Craiova, Dolj County, Romania
Cluj CF University Hospital, Cluj Napoca, , Romania
Constanta Clinical County Hospital, Constanta, , Romania
State Institution, Moscow City Oncology Hospital #62, Moscow, Krasnogorsky region, Russian Federation
State Medical Institution "Stavropol Regional Clinical Oncology Center", Stavropol,, Stavropol region,, Russian Federation
State Medical Institution, Arkhankelsk Regional Clinical Oncology Center, Arkhangelsk, , Russian Federation
State Medical Institution, Altai Regional Oncology Center, Barnaul, , Russian Federation
Chelyabinsk Regional Clinical Oncology Center, Chelyabinsk, , Russian Federation
State Budget-funded Medical Institution of Sverdlovsk Region "Sverdlovsk Regional Oncology Center", Ekaterinburg, , Russian Federation
Clinical Oncology Center, Kazan, , Russian Federation
State Treatment and Prevention Institution, Kirov Regional Clinical Oncology Center, Kirov, , Russian Federation
State Medical Institution "Clinical Oncology Center #1" under the Ministry of Health of Krasnodar Region, Krasnodar, , Russian Federation
State Medical Institution, Regional Oncology Center #2, Surgery department, Magnitogorsk, , Russian Federation
N.N. Blokhin Cancere Research Center under the Russian Academy of Medical Sciences, Moscow, , Russian Federation
Federal State Institution, Central Clinical Hospital with Outpatient Unit under the Russian Presidential Administration, Moscow, , Russian Federation
Federal State Institution "Privolzhskiy District Medical Center of Federal Bio-medical Agency", Nizhniy Novgorod, , Russian Federation
State Medical Institution of the Omsk Region, Clincial Oncology center, Omsk, , Russian Federation
State Medical Institution "Orenburg Regional Clinical Oncology Center", Orenburg,, , Russian Federation
State Medicinal Institution, Reginal oncology center, Penza, , Russian Federation
State Medical Institution "Republic Oncology Center", Petrozavodsk, , Russian Federation
Pyatigorsk Affiliate of State Medical Institution, Stavropol Regional Clinical Oncology Center, Pyatigorsk, , Russian Federation
State Medical Institution "Leningrad Regional Oncology Center", Saint-Petersburg,, , Russian Federation
Samara Regional Clinical Oncology Center, Samara, , Russian Federation
State Medical Institution, Oncology Center #2 under the Krasnodar Region Healthcare Department, Sochi, , Russian Federation
Federal State Medical Institution, N.N. Petrov Research Institute of Oncology under the Federal Agency for High-Tech Medical Care of the Russian Federation, Oncogynecology Department, St Petersburg, , Russian Federation
St Petersburg State Medical Institution, City clinical oncology center, St Petersburg, , Russian Federation
State Medical Institution, Tambov Regional Oncology Center #2, Tambov, , Russian Federation
State Medical Institution, Voronezh Regional Clinical Oncology Center, Voronezh, , Russian Federation
State Medical Institution of the Yaroslavl, Region Clinical Oncology Center, Yaroslavl, , Russian Federation
Institut za onkologiju i radiologiju Srbije, Klinika za medikalnu onkologiju, Belgrade, , Serbia
Klinički Bolnički Centar Kragujevac, Centar za onkologiju i radioterapiju, Kragujevac, , Serbia
Klinički Centar Niš, Klinika za onkologiju, Niš, , Serbia
Institut za onkologiju Vojvodine, Klinika za operativnu onkologiju, Sremska Kamenica, , Serbia
Onkologicke oddelenie, FNsP F. D. Roosevelta, Banska Bysterica, , Slovakia
Interne oddelenie, Narodny onkologicky ustav, Bratilslava, , Slovakia
Crimean Republicann Oncology Dispensary, Simferopol, , Slovakia
Divisionen för Onkologi , Sahlgrenska Universitetssjukhuset, Göteborg, , Sweden
Onkologikliniken, Universitetssjukhuset Linköping, Linköping, , Sweden
Onkologiska Kliniken, Universitetssjukhuset Lund, Lund, , Sweden
Gyn-Onkologiska kliniken, Norrlands universitetssjukhus, Umeå, , Sweden
Kliniken för Gynekologisk Onkologi, Regionsjukhuset, Örebro, , Sweden
Kyiv Regional Oncology Center, Kyiv, Bagautivska str. 1, Ukraine
Kharkiv Regional Clinical Oncology, Kharkiv, Lisoparkivska str 4, Ukraine
Ivano-Frankivsk Regional Oncology Center, Ivano-Frankivsk, 76018, Medychna str.17, Ukraine
Cherkassy Regional Oncological Centre, Cherkassy, , Ukraine
Cherkassy Regional Oncological Centre, Chernivtsy, , Ukraine
KZ, City Clinical Hospital #19 City oncology Center, Dnepropetrovsk, , Ukraine
Multi-profile clinical hospital#4, Dnipropetrovsk, , Ukraine
Donetsk Regional Antitumor Center, Donetsk, , Ukraine
"S.P. Grygoryev Institute of Medical Radiology of the Academy of Medical Science of Ukraine, Kharkiv, , Ukraine
Kherson Reginal Oncological Center, Kherson, , Ukraine
DU, National Institute of Cancer, Department of Oncogynecology, Kiev, , Ukraine
Kiev City Oncology center, Kiev, , Ukraine
Lugansk Regional Oncology Center, Lugansk, , Ukraine
Odessa City Oncological Center, Odessa, , Ukraine
Sumy Regional Onclolgy Center, Sumy, , Ukraine
Ternopil Regional Oncology Hospital, Ternopil, , Ukraine
Name: Ignace Vergote, Prof.
Affiliation: Division of Gynaecological Oncology, Department of Obstetrics and Gynaecology, University Hospitals Leuven, Belgium
Role: PRINCIPAL_INVESTIGATOR