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Study of Paclitaxel in Patients With Ovarian Cancer

Primary Purpose

Epithelial Ovarian Cancer, Primary Peritoneal Cancer, Fallopian Tube Cancer

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Paclical®
Taxol®
Sponsored by
Oasmia Pharmaceutical AB
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epithelial Ovarian Cancer focused on measuring Ovarian Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Histological or cytological confirmed epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer.
  • 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:

  • Patient has peripheral neuropathy of grade ≥ 2 per NCI-CTCAE version 3.0
  • 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)

Sites / Locations

  • Gomel Regional Clincial Oncology Center
  • Minsk City Clinical Oncology Hospital
  • Alexandrov National Cancer Center of Belarus
  • Vitebsk Regional Clinical Oncology Center
  • Department of gyneacology, Campus Gasthuisberg
  • Regional Oncology Dispensary
  • Hospital for a Active Treatment, Tsaritsa Yoanna
  • Regional Oncology Dispensary
  • Klinički Bolnički Centar Rijeka
  • Klinički Bolnički Centar Split
  • Klinikčki Bolnički Centar Zagreb
  • Onkologická klinika, Fakultní nemocnice Královské Vinohrady
  • Onkologické a radioterapeutické oddělení, Fakultní nemocnice Plzeň
  • Radioterapeutická a onkologická klinika, Fakultní nemocnice Královské Vinohrady
  • Ústav radiační onkologie, Fakultní nemocnice Na Bulovce
  • Onkologisk Afdelning, Herning Sygehus
  • Kuopion Yliopistollinen Sairaala, Naisten Klinikka
  • Turun Yliopistollinen Keskussairaala, Naisten Klinikka,
  • Kaposi Mór Megyei Kórház, Onkológiai Tanszék
  • B.-A.-Z. Megyei Kórház és Egyetemi Oktató Kórház, Észak-Kelet Magyarországi Regionális Klinikai Farmakológiai Központ
  • Szabolcs-Szatmár-Bereg Megyei Önkormányzat Jósa András Oktató Kórháza, Onkoradiológia
  • Veszprém Megyei Csolnoky Ferenc Kórház-Rendelőintézet ZRT
  • Zala Megyei Kórház, Onkológia
  • Latvian Oncology Center of Riga Easter Hospital Ltd
  • Kaunas Medical University Hospital, Oncology Clinic
  • Institute of Oncology, Vilnius University
  • County Clinical Emergency Hospital Oradea
  • MEDITECH SRL, ORIZONT Polyclinic
  • Cluj CF University Hospital
  • Constanta Clinical County Hospital
  • State Institution, Moscow City Oncology Hospital #62
  • State Medical Institution "Stavropol Regional Clinical Oncology Center"
  • State Medical Institution, Arkhankelsk Regional Clinical Oncology Center
  • State Medical Institution, Altai Regional Oncology Center
  • Chelyabinsk Regional Clinical Oncology Center
  • State Budget-funded Medical Institution of Sverdlovsk Region "Sverdlovsk Regional Oncology Center"
  • Clinical Oncology Center
  • State Treatment and Prevention Institution, Kirov Regional Clinical Oncology Center
  • State Medical Institution "Clinical Oncology Center #1" under the Ministry of Health of Krasnodar Region
  • State Medical Institution, Regional Oncology Center #2, Surgery department
  • N.N. Blokhin Cancere Research Center under the Russian Academy of Medical Sciences
  • Federal State Institution, Central Clinical Hospital with Outpatient Unit under the Russian Presidential Administration
  • Federal State Institution "Privolzhskiy District Medical Center of Federal Bio-medical Agency"
  • State Medical Institution of the Omsk Region, Clincial Oncology center
  • State Medical Institution "Orenburg Regional Clinical Oncology Center"
  • State Medicinal Institution, Reginal oncology center
  • State Medical Institution "Republic Oncology Center"
  • Pyatigorsk Affiliate of State Medical Institution, Stavropol Regional Clinical Oncology Center
  • State Medical Institution "Leningrad Regional Oncology Center"
  • Samara Regional Clinical Oncology Center
  • State Medical Institution, Oncology Center #2 under the Krasnodar Region Healthcare Department
  • 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 State Medical Institution, City clinical oncology center
  • State Medical Institution, Tambov Regional Oncology Center #2
  • State Medical Institution, Voronezh Regional Clinical Oncology Center
  • State Medical Institution of the Yaroslavl, Region Clinical Oncology Center
  • Institut za onkologiju i radiologiju Srbije, Klinika za medikalnu onkologiju
  • Klinički Bolnički Centar Kragujevac, Centar za onkologiju i radioterapiju
  • Klinički Centar Niš, Klinika za onkologiju
  • Institut za onkologiju Vojvodine, Klinika za operativnu onkologiju
  • Onkologicke oddelenie, FNsP F. D. Roosevelta
  • Interne oddelenie, Narodny onkologicky ustav
  • Crimean Republicann Oncology Dispensary
  • Divisionen för Onkologi , Sahlgrenska Universitetssjukhuset
  • Onkologikliniken, Universitetssjukhuset Linköping
  • Onkologiska Kliniken, Universitetssjukhuset Lund
  • Gyn-Onkologiska kliniken, Norrlands universitetssjukhus
  • Kliniken för Gynekologisk Onkologi, Regionsjukhuset
  • Kyiv Regional Oncology Center
  • Kharkiv Regional Clinical Oncology
  • Ivano-Frankivsk Regional Oncology Center
  • Cherkassy Regional Oncological Centre
  • Cherkassy Regional Oncological Centre
  • KZ, City Clinical Hospital #19 City oncology Center
  • Multi-profile clinical hospital#4
  • Donetsk Regional Antitumor Center
  • "S.P. Grygoryev Institute of Medical Radiology of the Academy of Medical Science of Ukraine
  • Kherson Reginal Oncological Center
  • DU, National Institute of Cancer, Department of Oncogynecology
  • Kiev City Oncology center
  • Lugansk Regional Oncology Center
  • Odessa City Oncological Center
  • Sumy Regional Onclolgy Center
  • Ternopil Regional Oncology Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Paclitaxel, micellar (Paclical®)

Paclitaxel, CrEL (Taxol®)

Arm Description

Outcomes

Primary Outcome Measures

Progression free survival (PFS).
Change in Area under the curve of CA 125
Incidence and severity of hypersensitivity reactions

Secondary Outcome Measures

Nadir and time to nadir of CA 125 during and after treatment
T½ of CA 125
Safety and tolerability
Response rate using CA 125
Overall survival

Full Information

First Posted
September 28, 2009
Last Updated
February 3, 2014
Sponsor
Oasmia Pharmaceutical AB
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1. Study Identification

Unique Protocol Identification Number
NCT00989131
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 Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
October 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Oasmia Pharmaceutical AB

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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®.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epithelial Ovarian Cancer, Primary Peritoneal Cancer, Fallopian Tube Cancer
Keywords
Ovarian Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
789 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Paclitaxel, micellar (Paclical®)
Arm Type
Experimental
Arm Title
Paclitaxel, CrEL (Taxol®)
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Paclical®
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Taxol®
Intervention Description
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.
Primary Outcome Measure Information:
Title
Progression free survival (PFS).
Title
Change in Area under the curve of CA 125
Title
Incidence and severity of hypersensitivity reactions
Secondary Outcome Measure Information:
Title
Nadir and time to nadir of CA 125 during and after treatment
Title
T½ of CA 125
Title
Safety and tolerability
Title
Response rate using CA 125
Title
Overall survival

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histological or cytological confirmed epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer. 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: Patient has peripheral neuropathy of grade ≥ 2 per NCI-CTCAE version 3.0 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ignace Vergote, Prof.
Organizational Affiliation
Division of Gynaecological Oncology, Department of Obstetrics and Gynaecology, University Hospitals Leuven, Belgium
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gomel Regional Clincial Oncology Center
City
Gomel
ZIP/Postal Code
246012
Country
Belarus
Facility Name
Minsk City Clinical Oncology Hospital
City
Minsk
ZIP/Postal Code
220013
Country
Belarus
Facility Name
Alexandrov National Cancer Center of Belarus
City
Minsk
ZIP/Postal Code
223040
Country
Belarus
Facility Name
Vitebsk Regional Clinical Oncology Center
City
Vitebsk
ZIP/Postal Code
210603
Country
Belarus
Facility Name
Department of gyneacology, Campus Gasthuisberg
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Regional Oncology Dispensary
City
Shumen
ZIP/Postal Code
9700
Country
Bulgaria
Facility Name
Hospital for a Active Treatment, Tsaritsa Yoanna
City
Sofia
ZIP/Postal Code
1540
Country
Bulgaria
Facility Name
Regional Oncology Dispensary
City
Stara Zagora
ZIP/Postal Code
6000
Country
Bulgaria
Facility Name
Klinički Bolnički Centar Rijeka
City
Rijeka
ZIP/Postal Code
51 000
Country
Croatia
Facility Name
Klinički Bolnički Centar Split
City
Split
ZIP/Postal Code
21 000
Country
Croatia
Facility Name
Klinikčki Bolnički Centar Zagreb
City
Zagreb
ZIP/Postal Code
10 000
Country
Croatia
Facility Name
Onkologická klinika, Fakultní nemocnice Královské Vinohrady
City
Olomouc
ZIP/Postal Code
775 20
Country
Czech Republic
Facility Name
Onkologické a radioterapeutické oddělení, Fakultní nemocnice Plzeň
City
Plzen
ZIP/Postal Code
30100
Country
Czech Republic
Facility Name
Radioterapeutická a onkologická klinika, Fakultní nemocnice Královské Vinohrady
City
Prague
ZIP/Postal Code
100 34
Country
Czech Republic
Facility Name
Ústav radiační onkologie, Fakultní nemocnice Na Bulovce
City
Prague
ZIP/Postal Code
180 81
Country
Czech Republic
Facility Name
Onkologisk Afdelning, Herning Sygehus
City
Herning
ZIP/Postal Code
7400
Country
Denmark
Facility Name
Kuopion Yliopistollinen Sairaala, Naisten Klinikka
City
Kuopio
ZIP/Postal Code
702 10
Country
Finland
Facility Name
Turun Yliopistollinen Keskussairaala, Naisten Klinikka,
City
Turku
ZIP/Postal Code
205 20
Country
Finland
Facility Name
Kaposi Mór Megyei Kórház, Onkológiai Tanszék
City
Kaposvár
ZIP/Postal Code
7400
Country
Hungary
Facility Name
B.-A.-Z. Megyei Kórház és Egyetemi Oktató Kórház, Észak-Kelet Magyarországi Regionális Klinikai Farmakológiai Központ
City
Miskolc
ZIP/Postal Code
3526
Country
Hungary
Facility Name
Szabolcs-Szatmár-Bereg Megyei Önkormányzat Jósa András Oktató Kórháza, Onkoradiológia
City
Nyíregyháza
ZIP/Postal Code
4400
Country
Hungary
Facility Name
Veszprém Megyei Csolnoky Ferenc Kórház-Rendelőintézet ZRT
City
Veszprém
ZIP/Postal Code
8200
Country
Hungary
Facility Name
Zala Megyei Kórház, Onkológia
City
Zalaegerszeg
ZIP/Postal Code
8900
Country
Hungary
Facility Name
Latvian Oncology Center of Riga Easter Hospital Ltd
City
Riga
ZIP/Postal Code
1079
Country
Latvia
Facility Name
Kaunas Medical University Hospital, Oncology Clinic
City
Kaunas
ZIP/Postal Code
50009
Country
Lithuania
Facility Name
Institute of Oncology, Vilnius University
City
Vilnius
ZIP/Postal Code
08 660
Country
Lithuania
Facility Name
County Clinical Emergency Hospital Oradea
City
Oradea
State/Province
Bihor County
ZIP/Postal Code
410167
Country
Romania
Facility Name
MEDITECH SRL, ORIZONT Polyclinic
City
Craiova
State/Province
Dolj County
ZIP/Postal Code
200535
Country
Romania
Facility Name
Cluj CF University Hospital
City
Cluj Napoca
ZIP/Postal Code
400015
Country
Romania
Facility Name
Constanta Clinical County Hospital
City
Constanta
ZIP/Postal Code
900591
Country
Romania
Facility Name
State Institution, Moscow City Oncology Hospital #62
City
Moscow
State/Province
Krasnogorsky region
Country
Russian Federation
Facility Name
State Medical Institution "Stavropol Regional Clinical Oncology Center"
City
Stavropol,
State/Province
Stavropol region,
ZIP/Postal Code
355047,
Country
Russian Federation
Facility Name
State Medical Institution, Arkhankelsk Regional Clinical Oncology Center
City
Arkhangelsk
ZIP/Postal Code
163045
Country
Russian Federation
Facility Name
State Medical Institution, Altai Regional Oncology Center
City
Barnaul
ZIP/Postal Code
65 60 49
Country
Russian Federation
Facility Name
Chelyabinsk Regional Clinical Oncology Center
City
Chelyabinsk
ZIP/Postal Code
454087
Country
Russian Federation
Facility Name
State Budget-funded Medical Institution of Sverdlovsk Region "Sverdlovsk Regional Oncology Center"
City
Ekaterinburg
ZIP/Postal Code
620036
Country
Russian Federation
Facility Name
Clinical Oncology Center
City
Kazan
ZIP/Postal Code
420029
Country
Russian Federation
Facility Name
State Treatment and Prevention Institution, Kirov Regional Clinical Oncology Center
City
Kirov
ZIP/Postal Code
610021
Country
Russian Federation
Facility Name
State Medical Institution "Clinical Oncology Center #1" under the Ministry of Health of Krasnodar Region
City
Krasnodar
ZIP/Postal Code
350040
Country
Russian Federation
Facility Name
State Medical Institution, Regional Oncology Center #2, Surgery department
City
Magnitogorsk
ZIP/Postal Code
455001
Country
Russian Federation
Facility Name
N.N. Blokhin Cancere Research Center under the Russian Academy of Medical Sciences
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
Federal State Institution, Central Clinical Hospital with Outpatient Unit under the Russian Presidential Administration
City
Moscow
ZIP/Postal Code
121356
Country
Russian Federation
Facility Name
Federal State Institution "Privolzhskiy District Medical Center of Federal Bio-medical Agency"
City
Nizhniy Novgorod
ZIP/Postal Code
603109
Country
Russian Federation
Facility Name
State Medical Institution of the Omsk Region, Clincial Oncology center
City
Omsk
ZIP/Postal Code
644013
Country
Russian Federation
Facility Name
State Medical Institution "Orenburg Regional Clinical Oncology Center"
City
Orenburg,
ZIP/Postal Code
460021,
Country
Russian Federation
Facility Name
State Medicinal Institution, Reginal oncology center
City
Penza
ZIP/Postal Code
440071
Country
Russian Federation
Facility Name
State Medical Institution "Republic Oncology Center"
City
Petrozavodsk
ZIP/Postal Code
18500
Country
Russian Federation
Facility Name
Pyatigorsk Affiliate of State Medical Institution, Stavropol Regional Clinical Oncology Center
City
Pyatigorsk
ZIP/Postal Code
357500
Country
Russian Federation
Facility Name
State Medical Institution "Leningrad Regional Oncology Center"
City
Saint-Petersburg,
ZIP/Postal Code
191104,
Country
Russian Federation
Facility Name
Samara Regional Clinical Oncology Center
City
Samara
ZIP/Postal Code
443066
Country
Russian Federation
Facility Name
State Medical Institution, Oncology Center #2 under the Krasnodar Region Healthcare Department
City
Sochi
ZIP/Postal Code
354057
Country
Russian Federation
Facility Name
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
City
St Petersburg
ZIP/Postal Code
197758
Country
Russian Federation
Facility Name
St Petersburg State Medical Institution, City clinical oncology center
City
St Petersburg
ZIP/Postal Code
198255
Country
Russian Federation
Facility Name
State Medical Institution, Tambov Regional Oncology Center #2
City
Tambov
ZIP/Postal Code
392013
Country
Russian Federation
Facility Name
State Medical Institution, Voronezh Regional Clinical Oncology Center
City
Voronezh
ZIP/Postal Code
394000
Country
Russian Federation
Facility Name
State Medical Institution of the Yaroslavl, Region Clinical Oncology Center
City
Yaroslavl
ZIP/Postal Code
150054
Country
Russian Federation
Facility Name
Institut za onkologiju i radiologiju Srbije, Klinika za medikalnu onkologiju
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Klinički Bolnički Centar Kragujevac, Centar za onkologiju i radioterapiju
City
Kragujevac
ZIP/Postal Code
34000
Country
Serbia
Facility Name
Klinički Centar Niš, Klinika za onkologiju
City
Niš
ZIP/Postal Code
18000
Country
Serbia
Facility Name
Institut za onkologiju Vojvodine, Klinika za operativnu onkologiju
City
Sremska Kamenica
ZIP/Postal Code
21204
Country
Serbia
Facility Name
Onkologicke oddelenie, FNsP F. D. Roosevelta
City
Banska Bysterica
ZIP/Postal Code
975 17
Country
Slovakia
Facility Name
Interne oddelenie, Narodny onkologicky ustav
City
Bratilslava
ZIP/Postal Code
83310
Country
Slovakia
Facility Name
Crimean Republicann Oncology Dispensary
City
Simferopol
ZIP/Postal Code
95017
Country
Slovakia
Facility Name
Divisionen för Onkologi , Sahlgrenska Universitetssjukhuset
City
Göteborg
ZIP/Postal Code
413 45
Country
Sweden
Facility Name
Onkologikliniken, Universitetssjukhuset Linköping
City
Linköping
ZIP/Postal Code
581 85
Country
Sweden
Facility Name
Onkologiska Kliniken, Universitetssjukhuset Lund
City
Lund
ZIP/Postal Code
221 85
Country
Sweden
Facility Name
Gyn-Onkologiska kliniken, Norrlands universitetssjukhus
City
Umeå
ZIP/Postal Code
901 85
Country
Sweden
Facility Name
Kliniken för Gynekologisk Onkologi, Regionsjukhuset
City
Örebro
ZIP/Postal Code
701 85
Country
Sweden
Facility Name
Kyiv Regional Oncology Center
City
Kyiv
State/Province
Bagautivska str. 1
ZIP/Postal Code
04107
Country
Ukraine
Facility Name
Kharkiv Regional Clinical Oncology
City
Kharkiv
State/Province
Lisoparkivska str 4
ZIP/Postal Code
610 70
Country
Ukraine
Facility Name
Ivano-Frankivsk Regional Oncology Center
City
Ivano-Frankivsk, 76018
State/Province
Medychna str.17
ZIP/Postal Code
76018
Country
Ukraine
Facility Name
Cherkassy Regional Oncological Centre
City
Cherkassy
ZIP/Postal Code
18009
Country
Ukraine
Facility Name
Cherkassy Regional Oncological Centre
City
Chernivtsy
Country
Ukraine
Facility Name
KZ, City Clinical Hospital #19 City oncology Center
City
Dnepropetrovsk
ZIP/Postal Code
49100
Country
Ukraine
Facility Name
Multi-profile clinical hospital#4
City
Dnipropetrovsk
ZIP/Postal Code
46102
Country
Ukraine
Facility Name
Donetsk Regional Antitumor Center
City
Donetsk
ZIP/Postal Code
83092
Country
Ukraine
Facility Name
"S.P. Grygoryev Institute of Medical Radiology of the Academy of Medical Science of Ukraine
City
Kharkiv
ZIP/Postal Code
61024
Country
Ukraine
Facility Name
Kherson Reginal Oncological Center
City
Kherson
ZIP/Postal Code
73000
Country
Ukraine
Facility Name
DU, National Institute of Cancer, Department of Oncogynecology
City
Kiev
ZIP/Postal Code
03022
Country
Ukraine
Facility Name
Kiev City Oncology center
City
Kiev
ZIP/Postal Code
03115
Country
Ukraine
Facility Name
Lugansk Regional Oncology Center
City
Lugansk
ZIP/Postal Code
91047
Country
Ukraine
Facility Name
Odessa City Oncological Center
City
Odessa
Country
Ukraine
Facility Name
Sumy Regional Onclolgy Center
City
Sumy
ZIP/Postal Code
40005
Country
Ukraine
Facility Name
Ternopil Regional Oncology Hospital
City
Ternopil
Country
Ukraine

12. IPD Sharing Statement

Citations:
PubMed Identifier
31826802
Citation
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.
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Study of Paclitaxel in Patients With Ovarian Cancer

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