Clinical trial NCT00989131: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Epithelial Ovarian Cancer
Primary Peritoneal Cancer
Fallopian Tube Cancer
Keywords: Ovarian Cancer
Lead sponsor: Oasmia Pharmaceutical AB
Sponsor class: INDUSTRY
First posted: 2009-10-02
Enrollment: 789
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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®.


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)

Primary outcomes:
measure: Progression free survival (PFS).
measure: Change in Area under the curve of CA 125
measure: Incidence and severity of hypersensitivity reactions
Secondary outcomes:
measure: Nadir and time to nadir of CA 125 during and after treatment
measure: T½ of CA 125
measure: Safety and tolerability
measure: Response rate using CA 125
measure: Overall survival
Other outcomes:
Locations:
city: Gomel
country: Belarus
facility: Gomel Regional Clincial Oncology Center
city: Minsk
country: Belarus
facility: Minsk City Clinical Oncology Hospital
city: Minsk
country: Belarus
facility: Alexandrov National Cancer Center of Belarus
city: Vitebsk
country: Belarus
facility: Vitebsk Regional Clinical Oncology Center
city: Leuven
country: Belgium
facility: Department of gyneacology, Campus Gasthuisberg
city: Shumen
country: Bulgaria
facility: Regional Oncology Dispensary
city: Sofia
country: Bulgaria
facility: Hospital for a Active Treatment, Tsaritsa Yoanna
city: Stara Zagora
country: Bulgaria
facility: Regional Oncology Dispensary
city: Rijeka
country: Croatia
facility: Klinički Bolnički Centar Rijeka
city: Split
country: Croatia
facility: Klinički Bolnički Centar Split
city: Zagreb
country: Croatia
facility: Klinikčki Bolnički Centar Zagreb
city: Olomouc
country: Czech Republic
facility: Onkologická klinika, Fakultní nemocnice Královské Vinohrady
city: Plzen
country: Czech Republic
facility: Onkologické a radioterapeutické oddělení, Fakultní nemocnice Plzeň
city: Prague
country: Czech Republic
facility: Radioterapeutická a onkologická klinika, Fakultní nemocnice Královské Vinohrady
city: Prague
country: Czech Republic
facility: Ústav radiační onkologie, Fakultní nemocnice Na Bulovce
city: Herning
country: Denmark
facility: Onkologisk Afdelning, Herning Sygehus
city: Kuopio
country: Finland
facility: Kuopion Yliopistollinen Sairaala, Naisten Klinikka
city: Turku
country: Finland
facility: Turun Yliopistollinen Keskussairaala, Naisten Klinikka,
city: Kaposvár
country: Hungary
facility: Kaposi Mór Megyei Kórház, Onkológiai Tanszék
city: Miskolc
country: Hungary
facility: B.-A.-Z. Megyei Kórház és Egyetemi Oktató Kórház, Észak-Kelet Magyarországi Regionális Klinikai Farmakológiai Központ
city: Nyíregyháza
country: Hungary
facility: Szabolcs-Szatmár-Bereg Megyei Önkormányzat Jósa András Oktató Kórháza, Onkoradiológia
city: Veszprém
country: Hungary
facility: Veszprém Megyei Csolnoky Ferenc Kórház-Rendelőintézet ZRT
city: Zalaegerszeg
country: Hungary
facility: Zala Megyei Kórház, Onkológia
city: Riga
country: Latvia
facility: Latvian Oncology Center of Riga Easter Hospital Ltd
city: Kaunas
country: Lithuania
facility: Kaunas Medical University Hospital, Oncology Clinic
city: Vilnius
country: Lithuania
facility: Institute of Oncology, Vilnius University
city: Oradea
country: Romania
facility: County Clinical Emergency Hospital Oradea
state: Bihor County
city: Craiova
country: Romania
facility: MEDITECH SRL, ORIZONT Polyclinic
state: Dolj County
city: Cluj Napoca
country: Romania
facility: Cluj CF University Hospital
city: Constanta
country: Romania
facility: Constanta Clinical County Hospital
city: Moscow
country: Russian Federation
facility: State Institution, Moscow City Oncology Hospital #62
state: Krasnogorsky region
city: Stavropol,
country: Russian Federation
facility: State Medical Institution "Stavropol Regional Clinical Oncology Center"
state: Stavropol region,
city: Arkhangelsk
country: Russian Federation
facility: State Medical Institution, Arkhankelsk Regional Clinical Oncology Center
city: Barnaul
country: Russian Federation
facility: State Medical Institution, Altai Regional Oncology Center
city: Chelyabinsk
country: Russian Federation
facility: Chelyabinsk Regional Clinical Oncology Center
city: Ekaterinburg
country: Russian Federation
facility: State Budget-funded Medical Institution of Sverdlovsk Region "Sverdlovsk Regional Oncology Center"
city: Kazan
country: Russian Federation
facility: Clinical Oncology Center
city: Kirov
country: Russian Federation
facility: State Treatment and Prevention Institution, Kirov Regional Clinical Oncology Center
city: Krasnodar
country: Russian Federation
facility: State Medical Institution "Clinical Oncology Center #1" under the Ministry of Health of Krasnodar Region
city: Magnitogorsk
country: Russian Federation
facility: State Medical Institution, Regional Oncology Center #2, Surgery department
city: Moscow
country: Russian Federation
facility: N.N. Blokhin Cancere Research Center under the Russian Academy of Medical Sciences
city: Moscow
country: Russian Federation
facility: Federal State Institution, Central Clinical Hospital with Outpatient Unit under the Russian Presidential Administration
city: Nizhniy Novgorod
country: Russian Federation
facility: Federal State Institution "Privolzhskiy District Medical Center of Federal Bio-medical Agency"
city: Omsk
country: Russian Federation
facility: State Medical Institution of the Omsk Region, Clincial Oncology center
city: Orenburg,
country: Russian Federation
facility: State Medical Institution "Orenburg Regional Clinical Oncology Center"
city: Penza
country: Russian Federation
facility: State Medicinal Institution, Reginal oncology center
city: Petrozavodsk
country: Russian Federation
facility: State Medical Institution "Republic Oncology Center"
city: Pyatigorsk
country: Russian Federation
facility: Pyatigorsk Affiliate of State Medical Institution, Stavropol Regional Clinical Oncology Center
city: Saint-Petersburg,
country: Russian Federation
facility: State Medical Institution "Leningrad Regional Oncology Center"
city: Samara
country: Russian Federation
facility: Samara Regional Clinical Oncology Center
city: Sochi
country: Russian Federation
facility: State Medical Institution, Oncology Center #2 under the Krasnodar Region Healthcare Department
city: St Petersburg
country: Russian Federation
facility: 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
country: Russian Federation
facility: St Petersburg State Medical Institution, City clinical oncology center
city: Tambov
country: Russian Federation
facility: State Medical Institution, Tambov Regional Oncology Center #2
city: Voronezh
country: Russian Federation
facility: State Medical Institution, Voronezh Regional Clinical Oncology Center
city: Yaroslavl
country: Russian Federation
facility: State Medical Institution of the Yaroslavl, Region Clinical Oncology Center
city: Belgrade
country: Serbia
facility: Institut za onkologiju i radiologiju Srbije, Klinika za medikalnu onkologiju
city: Kragujevac
country: Serbia
facility: Klinički Bolnički Centar Kragujevac, Centar za onkologiju i radioterapiju
city: Niš
country: Serbia
facility: Klinički Centar Niš, Klinika za onkologiju
city: Sremska Kamenica
country: Serbia
facility: Institut za onkologiju Vojvodine, Klinika za operativnu onkologiju
city: Banska Bysterica
country: Slovakia
facility: Onkologicke oddelenie, FNsP F. D. Roosevelta
city: Bratilslava
country: Slovakia
facility: Interne oddelenie, Narodny onkologicky ustav
city: Simferopol
country: Slovakia
facility: Crimean Republicann Oncology Dispensary
city: Göteborg
country: Sweden
facility: Divisionen för Onkologi , Sahlgrenska Universitetssjukhuset
city: Linköping
country: Sweden
facility: Onkologikliniken, Universitetssjukhuset Linköping
city: Lund
country: Sweden
facility: Onkologiska Kliniken, Universitetssjukhuset Lund
city: Umeå
country: Sweden
facility: Gyn-Onkologiska kliniken, Norrlands universitetssjukhus
city: Örebro
country: Sweden
facility: Kliniken för Gynekologisk Onkologi, Regionsjukhuset
city: Kyiv
country: Ukraine
facility: Kyiv Regional Oncology Center
state: Bagautivska str. 1
city: Kharkiv
country: Ukraine
facility: Kharkiv Regional Clinical Oncology
state: Lisoparkivska str 4
city: Ivano-Frankivsk, 76018
country: Ukraine
facility: Ivano-Frankivsk Regional Oncology Center
state: Medychna str.17
city: Cherkassy
country: Ukraine
facility: Cherkassy Regional Oncological Centre
city: Chernivtsy
country: Ukraine
facility: Cherkassy Regional Oncological Centre
city: Dnepropetrovsk
country: Ukraine
facility: KZ, City Clinical Hospital #19 City oncology Center
city: Dnipropetrovsk
country: Ukraine
facility: Multi-profile clinical hospital#4
city: Donetsk
country: Ukraine
facility: Donetsk Regional Antitumor Center
city: Kharkiv
country: Ukraine
facility: "S.P. Grygoryev Institute of Medical Radiology of the Academy of Medical Science of Ukraine
city: Kherson
country: Ukraine
facility: Kherson Reginal Oncological Center
city: Kiev
country: Ukraine
facility: DU, National Institute of Cancer, Department of Oncogynecology
city: Kiev
country: Ukraine
facility: Kiev City Oncology center
city: Lugansk
country: Ukraine
facility: Lugansk Regional Oncology Center
city: Odessa
country: Ukraine
facility: Odessa City Oncological Center
city: Sumy
country: Ukraine
facility: Sumy Regional Onclolgy Center
city: Ternopil
country: Ukraine
facility: Ternopil Regional Oncology Hospital
Study officials:
affiliation: Division of Gynaecological Oncology, Department of Obstetrics and Gynaecology, University Hospitals Leuven, Belgium
name: Ignace Vergote, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
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.