Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
789 participants
INTERVENTIONAL
2009-02-28
2013-10-31
Brief Summary
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PURPOSE: To study the efficay and safety of two different formulations of paclitaxel, Paclical® and Taxol®.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Paclitaxel, micellar (Paclical®)
Paclical®
250 mg/m2 of Paclical® is given as a one-hour IV infusion, followed by carboplatin, on day 1 of each 21 day cycle.
Number of Cycles: 6. Cycle 2-6 will be given with 3 weeks interval between treatments.
Paclitaxel, CrEL (Taxol®)
Taxol®
175 mg/m2 of Taxol® is given as 3 hour IV infusion, followed by carboplatin on day 1 of each 21 day cycle.
Number of Cycles: 6. Cycle 2-6 will be given with 3 weeks interval between treatments.
Interventions
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Paclical®
250 mg/m2 of Paclical® is given as a one-hour IV infusion, followed by carboplatin, on day 1 of each 21 day cycle.
Number of Cycles: 6. Cycle 2-6 will be given with 3 weeks interval between treatments.
Taxol®
175 mg/m2 of Taxol® is given as 3 hour IV infusion, followed by carboplatin on day 1 of each 21 day cycle.
Number of Cycles: 6. Cycle 2-6 will be given with 3 weeks interval between treatments.
Eligibility Criteria
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Inclusion Criteria
* Patients relapsing \> 6 months after end of first line or second line treatment including platinum based therapy. Prior therapy and duration of response will be documented in the CRF for descriptive analysis.
* CA 125 \>2 x upper normal limit (UNL) documented at two occasions, with more than one week interval, according to appendix I, patient groups A and B, measurable/non- measurable disease.
* Age \> 18 years
* Eastern Cooperative Oncology Group (ECOG) performance score 0-2
* Life expectancy \>12 weeks
* Patient has blood counts at baseline of:
* Absolute neutrophil count (ANC) \>1,5 x 109 / L.
* Platelet count \>100 x 109 / L
* Haemoglobin (Hb) ≥9g/dl (can be post transfusion)
* Alanine Aminotransferase (ALT) and/or Aspartate Aminotransferase (AST) \< 2 x UNL
* Total bilirubin ≤1.5 x UNL.
* Adequate renal function defined as serum creatinine \< 2.0 mg/dl or 177μmol/l.
* Alkaline phosphatase (ALP) \< 2.5 x UNL
* Signed informed consent obtained
Exclusion Criteria
* Surgical procedure due to progressive disease within 4 weeks of any of the CA-125 measurements
* Patient receiving concurrent hormonal, immuno-, or radiotherapy. Treatment must have stopped for at least 4 weeks before start of drug treatment (Day 1, Cycle 1).
* Bowel obstruction at screening
* Tumours of other origin or histology
* Patient of child-bearing potential, not practising adequate contraception, or pregnant or lactating women
* Patient has a history of severe allergy or severe hypersensitivity to study drugs
* Any uncontrolled medical problem that in the opinion of the investigator would preclude safe administration of the study drugs, e.g. heart, lung or kidney disease, suspicion of brain metastasis or mental disorder to make the patient unable to participate in the study
* Participation in an investigational drug study within 4 weeks prior to study treatment (Day 1, Cycle 1)
18 Years
FEMALE
No
Sponsors
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Oasmia Pharmaceutical AB
INDUSTRY
Responsible Party
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Principal Investigators
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Ignace Vergote, Prof.
Role: PRINCIPAL_INVESTIGATOR
Division of Gynaecological Oncology, Department of Obstetrics and Gynaecology, University Hospitals Leuven, Belgium
Locations
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Gomel Regional Clincial Oncology Center
Homyel, , 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, , Czechia
Onkologické a radioterapeutické oddělení, Fakultní nemocnice Plzeň
Pilsen, , Czechia
Radioterapeutická a onkologická klinika, Fakultní nemocnice Královské Vinohrady
Prague, , Czechia
Ústav radiační onkologie, Fakultní nemocnice Na Bulovce
Prague, , Czechia
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, Romania
Cluj CF University Hospital
Cluj-Napoca, , Romania
Constanta Clinical County Hospital
Constanța, , Romania
State Institution, Moscow City Oncology Hospital #62
Moscow, Krasnogorsky Region, Russia
State Medical Institution "Stavropol Regional Clinical Oncology Center"
Stavropol, Stavropol Kray, Russia
State Medical Institution, Arkhankelsk Regional Clinical Oncology Center
Arkhangelsk, , Russia
State Medical Institution, Altai Regional Oncology Center
Barnaul, , Russia
Chelyabinsk Regional Clinical Oncology Center
Chelyabinsk, , Russia
Clinical Oncology Center
Kazan', , Russia
State Treatment and Prevention Institution, Kirov Regional Clinical Oncology Center
Kirov, , Russia
State Medical Institution "Clinical Oncology Center #1" under the Ministry of Health of Krasnodar Region
Krasnodar, , Russia
State Medical Institution, Regional Oncology Center #2, Surgery department
Magnitogorsk, , Russia
N.N. Blokhin Cancere Research Center under the Russian Academy of Medical Sciences
Moscow, , Russia
Federal State Institution, Central Clinical Hospital with Outpatient Unit under the Russian Presidential Administration
Moscow, , Russia
Federal State Institution "Privolzhskiy District Medical Center of Federal Bio-medical Agency"
Nizhny Novgorod, , Russia
State Medical Institution of the Omsk Region, Clincial Oncology center
Omsk, , Russia
State Medical Institution "Orenburg Regional Clinical Oncology Center"
Orenburg, , Russia
State Medicinal Institution, Reginal oncology center
Penza, , Russia
State Medical Institution "Republic Oncology Center"
Petrozavodsk, , Russia
Pyatigorsk Affiliate of State Medical Institution, Stavropol Regional Clinical Oncology Center
Pyatigorsk, , Russia
State Medical Institution "Leningrad Regional Oncology Center"
Saint Petersburg, , Russia
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
Saint Petersburg, , Russia
St Petersburg State Medical Institution, City clinical oncology center
Saint Petersburg, , Russia
Samara Regional Clinical Oncology Center
Samara, , Russia
State Medical Institution, Oncology Center #2 under the Krasnodar Region Healthcare Department
Sochi, , Russia
State Medical Institution, Tambov Regional Oncology Center #2
Tambov, , Russia
State Medical Institution, Voronezh Regional Clinical Oncology Center
Voronezh, , Russia
State Medical Institution of the Yaroslavl, Region Clinical Oncology Center
Yaroslavl, , Russia
State Budget-funded Medical Institution of Sverdlovsk Region "Sverdlovsk Regional Oncology Center"
Yekaterinburg, , Russia
Institut za onkologiju i radiologiju Srbije, Klinika za medikalnu onkologiju
Belgrade, , Serbia
Institut za onkologiju Vojvodine, Klinika za operativnu onkologiju
Kamenitz, , Serbia
Klinički Bolnički Centar Kragujevac, Centar za onkologiju i radioterapiju
Kragujevac, , Serbia
Klinički Centar Niš, Klinika za onkologiju
Niš, , 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
Gothenburg, , Sweden
Onkologikliniken, Universitetssjukhuset Linköping
Linköping, , Sweden
Onkologiska Kliniken, Universitetssjukhuset Lund
Lund, , Sweden
Kliniken för Gynekologisk Onkologi, Regionsjukhuset
Örebro, , Sweden
Gyn-Onkologiska kliniken, Norrlands universitetssjukhus
Umeå, , 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, Medychna Str.17, Ukraine
Cherkassy Regional Oncological Centre
Cherkassy, , Ukraine
Cherkassy Regional Oncological Centre
Chernivtsy, , Ukraine
KZ, City Clinical Hospital #19 City oncology Center
Dnipro, , 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
Luhansk, , Ukraine
Odessa City Oncological Center
Odesa, , Ukraine
Sumy Regional Onclolgy Center
Sumy, , Ukraine
Ternopil Regional Oncology Hospital
Ternopil, , Ukraine
Countries
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References
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Vergote I, Bergfeldt K, Franquet A, Lisyanskaya AS, Bjermo H, Heldring N, Buyse M, Brize A. A randomized phase III trial in patients with recurrent platinum sensitive ovarian cancer comparing efficacy and safety of paclitaxel micellar and Cremophor EL-paclitaxel. Gynecol Oncol. 2020 Feb;156(2):293-300. doi: 10.1016/j.ygyno.2019.11.034. Epub 2019 Dec 9.
Other Identifiers
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OAS-07OVA
Identifier Type: -
Identifier Source: org_study_id
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