Study of Paclitaxel in Patients With Ovarian Cancer
- Conditions
- Epithelial Ovarian CancerPrimary Peritoneal CancerFallopian Tube Cancer
- Interventions
- Drug: Paclical®
- Registration Number
- NCT00989131
- Lead Sponsor
- Oasmia Pharmaceutical AB
- 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
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 789
-
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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Paclitaxel, micellar (Paclical®) Paclical® - Paclitaxel, CrEL (Taxol®) Taxol® -
- Primary Outcome Measures
Name Time Method Progression free survival (PFS). Incidence and severity of hypersensitivity reactions Change in Area under the curve of CA 125
- Secondary Outcome Measures
Name Time Method T½ of CA 125 Safety and tolerability Overall survival Nadir and time to nadir of CA 125 during and after treatment Response rate using CA 125
Trial Locations
- Locations (82)
Regional Oncology Dispensary
🇧🇬Stara Zagora, Bulgaria
B.-A.-Z. Megyei Kórház és Egyetemi Oktató Kórház, Észak-Kelet Magyarországi Regionális Klinikai Farmakológiai Központ
🇭🇺Miskolc, Hungary
Klinikčki Bolnički Centar Zagreb
🇭🇷Zagreb, Croatia
Klinički Bolnički Centar Kragujevac, Centar za onkologiju i radioterapiju
🇷🇸Kragujevac, Serbia
Onkologicke oddelenie, FNsP F. D. Roosevelta
🇸🇰Banska Bysterica, Slovakia
"S.P. Grygoryev Institute of Medical Radiology of the Academy of Medical Science of Ukraine
🇺🇦Kharkiv, Ukraine
Donetsk Regional Antitumor Center
🇺🇦Donetsk, Ukraine
KZ, City Clinical Hospital #19 City oncology Center
🇺🇦Dnepropetrovsk, Ukraine
Multi-profile clinical hospital#4
🇺🇦Dnipropetrovsk, Ukraine
DU, National Institute of Cancer, Department of Oncogynecology
🇺🇦Kiev, Ukraine
Lugansk Regional Oncology Center
🇺🇦Lugansk, Ukraine
Gomel Regional Clincial Oncology Center
🇧🇾Gomel, Belarus
Vitebsk Regional Clinical Oncology Center
🇧🇾Vitebsk, Belarus
Klinički Bolnički Centar Split
🇭🇷Split, Croatia
Onkologická klinika, Fakultní nemocnice Královské Vinohrady
🇨🇿Olomouc, Czech Republic
Ústav radiační onkologie, Fakultní nemocnice Na Bulovce
🇨🇿Prague, Czech Republic
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
State Budget-funded Medical Institution of Sverdlovsk Region "Sverdlovsk Regional Oncology Center"
🇷🇺Ekaterinburg, Russian Federation
Onkologické a radioterapeutické oddělení, Fakultní nemocnice Plzeň
🇨🇿Plzen, Czech Republic
Institute of Oncology, Vilnius University
🇱🇹Vilnius, Lithuania
Kliniken för Gynekologisk Onkologi, Regionsjukhuset
🇸🇪Örebro, Sweden
N.N. Blokhin Cancere Research Center under the Russian Academy of Medical Sciences
🇷🇺Moscow, Russian Federation
Chelyabinsk Regional Clinical Oncology Center
🇷🇺Chelyabinsk, Russian Federation
Pyatigorsk Affiliate of State Medical Institution, Stavropol Regional Clinical Oncology Center
🇷🇺Pyatigorsk, Russian Federation
Kuopion Yliopistollinen Sairaala, Naisten Klinikka
🇫🇮Kuopio, Finland
Veszprém Megyei Csolnoky Ferenc Kórház-Rendelőintézet ZRT
🇭🇺Veszprém, Hungary
Zala Megyei Kórház, Onkológia
🇭🇺Zalaegerszeg, Hungary
State Medical Institution, Regional Oncology Center #2, Surgery department
🇷🇺Magnitogorsk, Russian Federation
Cluj CF University Hospital
🇷🇴Cluj Napoca, Romania
State Medical Institution "Stavropol Regional Clinical Oncology Center"
🇷🇺Stavropol,, Stavropol region,, Russian Federation
Klinički Bolnički Centar Rijeka
🇭🇷Rijeka, Croatia
Federal State Institution, Central Clinical Hospital with Outpatient Unit under the Russian Presidential Administration
🇷🇺Moscow, Russian Federation
Klinički Centar Niš, Klinika za onkologiju
🇷🇸Niš, Serbia
Crimean Republicann Oncology Dispensary
🇸🇰Simferopol, Slovakia
Onkologiska Kliniken, Universitetssjukhuset Lund
🇸🇪Lund, Sweden
Federal State Institution "Privolzhskiy District Medical Center of Federal Bio-medical Agency"
🇷🇺Nizhniy Novgorod, Russian Federation
State Treatment and Prevention Institution, Kirov Regional Clinical Oncology Center
🇷🇺Kirov, Russian Federation
State Medical Institution "Orenburg Regional Clinical Oncology Center"
🇷🇺Orenburg,, Russian Federation
Ivano-Frankivsk Regional Oncology Center
🇺🇦Ivano-Frankivsk, 76018, Medychna str.17, Ukraine
Kharkiv Regional Clinical Oncology
🇺🇦Kharkiv, Lisoparkivska str 4, Ukraine
Cherkassy Regional Oncological Centre
🇺🇦Chernivtsy, Ukraine
Onkologisk Afdelning, Herning Sygehus
🇩🇰Herning, Denmark
State Medical Institution, Arkhankelsk Regional Clinical Oncology Center
🇷🇺Arkhangelsk, Russian Federation
Clinical Oncology Center
🇷🇺Kazan, Russian Federation
State Medical Institution "Clinical Oncology Center #1" under the Ministry of Health of Krasnodar Region
🇷🇺Krasnodar, Russian Federation
State Medicinal Institution, Reginal oncology center
🇷🇺Penza, Russian Federation
St Petersburg State Medical Institution, City clinical oncology center
🇷🇺St Petersburg, Russian Federation
Samara Regional Clinical Oncology Center
🇷🇺Samara, Russian Federation
State Medical Institution, Voronezh Regional Clinical Oncology Center
🇷🇺Voronezh, Russian Federation
Minsk City Clinical Oncology Hospital
🇧🇾Minsk, Belarus
Department of gyneacology, Campus Gasthuisberg
🇧🇪Leuven, Belgium
Alexandrov National Cancer Center of Belarus
🇧🇾Minsk, Belarus
Hospital for a Active Treatment, Tsaritsa Yoanna
🇧🇬Sofia, Bulgaria
Kaposi Mór Megyei Kórház, Onkológiai Tanszék
🇭🇺Kaposvár, Hungary
Radioterapeutická a onkologická klinika, Fakultní nemocnice Královské Vinohrady
🇨🇿Prague, Czech Republic
Szabolcs-Szatmár-Bereg Megyei Önkormányzat Jósa András Oktató Kórháza, Onkoradiológia
🇭🇺Nyíregyháza, Hungary
Kaunas Medical University Hospital, Oncology Clinic
🇱🇹Kaunas, Lithuania
County Clinical Emergency Hospital Oradea
🇷🇴Oradea, Bihor County, Romania
State Institution, Moscow City Oncology Hospital #62
🇷🇺Moscow, Krasnogorsky region, Russian Federation
State Medical Institution, Altai Regional Oncology Center
🇷🇺Barnaul, Russian Federation
State Medical Institution "Republic Oncology Center"
🇷🇺Petrozavodsk, Russian Federation
State Medical Institution, Oncology Center #2 under the Krasnodar Region Healthcare Department
🇷🇺Sochi, Russian Federation
State Medical Institution "Leningrad Regional Oncology Center"
🇷🇺Saint-Petersburg,, 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
Divisionen för Onkologi , Sahlgrenska Universitetssjukhuset
🇸🇪Göteborg, Sweden
Institut za onkologiju Vojvodine, Klinika za operativnu onkologiju
🇷🇸Sremska Kamenica, Serbia
Onkologikliniken, Universitetssjukhuset Linköping
🇸🇪Linköping, Sweden
Gyn-Onkologiska kliniken, Norrlands universitetssjukhus
🇸🇪Umeå, Sweden
Kyiv Regional Oncology Center
🇺🇦Kyiv, Bagautivska str. 1, Ukraine
Kherson Reginal Oncological Center
🇺🇦Kherson, Ukraine
Kiev City Oncology center
🇺🇦Kiev, Ukraine
Sumy Regional Onclolgy Center
🇺🇦Sumy, Ukraine
Ternopil Regional Oncology Hospital
🇺🇦Ternopil, Ukraine
Odessa City Oncological Center
🇺🇦Odessa, Ukraine
State Medical Institution of the Omsk Region, Clincial Oncology center
🇷🇺Omsk, Russian Federation
State Medical Institution, Tambov Regional Oncology Center #2
🇷🇺Tambov, Russian Federation
Latvian Oncology Center of Riga Easter Hospital Ltd
🇱🇻Riga, Latvia
Turun Yliopistollinen Keskussairaala, Naisten Klinikka,
🇫🇮Turku, Finland
Constanta Clinical County Hospital
🇷🇴Constanta, Romania
Interne oddelenie, Narodny onkologicky ustav
🇸🇰Bratilslava, Slovakia
MEDITECH SRL, ORIZONT Polyclinic
🇷🇴Craiova, Dolj County, Romania