Study of Paclitaxel in Patients With Ovarian Cancer

February 3, 2014 updated by: Oasmia Pharmaceutical AB

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)

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®.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

789

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belarus
      • Gomel, Belarus, 246012
        • Gomel Regional Clincial Oncology Center
      • Minsk, Belarus, 220013
        • Minsk City Clinical Oncology Hospital
      • Minsk, Belarus, 223040
        • Alexandrov National Cancer Center of Belarus
      • Vitebsk, Belarus, 210603
        • Vitebsk Regional Clinical Oncology Center
  • Belgium
      • Leuven, Belgium, 3000
        • Department of gyneacology, Campus Gasthuisberg
  • Bulgaria
      • Shumen, Bulgaria, 9700
        • Regional Oncology Dispensary
      • Sofia, Bulgaria, 1540
        • Hospital for a Active Treatment, Tsaritsa Yoanna
      • Stara Zagora, Bulgaria, 6000
        • Regional Oncology Dispensary
  • Croatia
      • Rijeka, Croatia, 51 000
        • Klinicki Bolnicki Centar Rijeka
      • Split, Croatia, 21 000
        • Klinički Bolnički Centar Split
      • Zagreb, Croatia, 10 000
        • Klinikčki Bolnički Centar Zagreb
  • Czech Republic
      • Olomouc, Czech Republic, 775 20
        • Onkologická klinika, Fakultní nemocnice Královské Vinohrady
      • Plzen, Czech Republic, 30100
        • Onkologické a radioterapeutické oddělení, Fakultní nemocnice Plzeň
      • Prague, Czech Republic, 100 34
        • Radioterapeutická a onkologická klinika, Fakultní nemocnice Královské Vinohrady
      • Prague, Czech Republic, 180 81
        • Ústav radiační onkologie, Fakultní nemocnice Na Bulovce
  • Denmark
      • Herning, Denmark, 7400
        • Onkologisk Afdelning, Herning Sygehus
  • Finland
      • Kuopio, Finland, 702 10
        • Kuopion Yliopistollinen Sairaala, Naisten Klinikka
      • Turku, Finland, 205 20
        • Turun Yliopistollinen Keskussairaala, Naisten Klinikka,
  • Hungary
      • Kaposvár, Hungary, 7400
        • Kaposi Mór Megyei Kórház, Onkológiai Tanszék
      • Miskolc, Hungary, 3526
        • B.-A.-Z. Megyei Kórház és Egyetemi Oktató Kórház, Észak-Kelet Magyarországi Regionális Klinikai Farmakológiai Központ
      • Nyíregyháza, Hungary, 4400
        • Szabolcs-Szatmár-Bereg Megyei Önkormányzat Jósa András Oktató Kórháza, Onkoradiológia
      • Veszprém, Hungary, 8200
        • Veszprém Megyei Csolnoky Ferenc Kórház-Rendelőintézet ZRT
      • Zalaegerszeg, Hungary, 8900
        • Zala Megyei Kórház, Onkológia
  • Latvia
      • Riga, Latvia, 1079
        • Latvian Oncology Center of Riga Easter Hospital Ltd
  • Lithuania
      • Kaunas, Lithuania, 50009
        • Kaunas Medical University Hospital, Oncology Clinic
      • Vilnius, Lithuania, 08 660
        • Institute of Oncology, Vilnius University
  • Romania
      • Cluj Napoca, Romania, 400015
        • Cluj CF University Hospital
      • Constanta, Romania, 900591
        • Constanta Clinical County Hospital
    • Bihor County
      • Oradea, Bihor County, Romania, 410167
        • County Clinical Emergency Hospital Oradea
    • Dolj County
      • Craiova, Dolj County, Romania, 200535
        • MEDITECH SRL, ORIZONT Polyclinic
  • Russian Federation
      • Arkhangelsk, Russian Federation, 163045
        • State Medical Institution, Arkhankelsk Regional Clinical Oncology Center
      • Barnaul, Russian Federation, 65 60 49
        • State Medical Institution, Altai Regional Oncology Center
      • Chelyabinsk, Russian Federation, 454087
        • Chelyabinsk Regional Clinical Oncology Center
      • Ekaterinburg, Russian Federation, 620036
        • State Budget-funded Medical Institution of Sverdlovsk Region "Sverdlovsk Regional Oncology Center"
      • Kazan, Russian Federation, 420029
        • Clinical Oncology Center
      • Kirov, Russian Federation, 610021
        • State Treatment and Prevention Institution, Kirov Regional Clinical Oncology Center
      • Krasnodar, Russian Federation, 350040
        • State Medical Institution "Clinical Oncology Center #1" under the Ministry of Health of Krasnodar Region
      • Magnitogorsk, Russian Federation, 455001
        • State Medical Institution, Regional Oncology Center #2, Surgery department
      • Moscow, Russian Federation, 115478
        • N.N. Blokhin Cancere Research Center under the Russian Academy of Medical Sciences
      • Moscow, Russian Federation, 121356
        • Federal State Institution, Central Clinical Hospital with Outpatient Unit under the Russian Presidential Administration
      • Nizhniy Novgorod, Russian Federation, 603109
        • Federal State Institution "Privolzhskiy District Medical Center of Federal Bio-medical Agency"
      • Omsk, Russian Federation, 644013
        • State Medical Institution of the Omsk Region, Clincial Oncology center
      • Orenburg,, Russian Federation, 460021,
        • State Medical Institution "Orenburg Regional Clinical Oncology Center"
      • Penza, Russian Federation, 440071
        • State Medicinal Institution, Reginal oncology center
      • Petrozavodsk, Russian Federation, 18500
        • State Medical Institution "Republic Oncology Center"
      • Pyatigorsk, Russian Federation, 357500
        • Pyatigorsk Affiliate of State Medical Institution, Stavropol Regional Clinical Oncology Center
      • Saint-Petersburg,, Russian Federation, 191104,
        • State Medical Institution "Leningrad Regional Oncology Center"
      • Samara, Russian Federation, 443066
        • Samara Regional Clinical Oncology Center
      • Sochi, Russian Federation, 354057
        • State Medical Institution, Oncology Center #2 under the Krasnodar Region Healthcare Department
      • St Petersburg, Russian Federation, 197758
        • 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, 198255
        • St Petersburg State Medical Institution, City clinical oncology center
      • Tambov, Russian Federation, 392013
        • State Medical Institution, Tambov Regional Oncology Center #2
      • Voronezh, Russian Federation, 394000
        • State Medical Institution, Voronezh Regional Clinical Oncology Center
      • Yaroslavl, Russian Federation, 150054
        • State Medical Institution of the Yaroslavl, Region Clinical Oncology Center
    • Krasnogorsky region
      • Moscow, Krasnogorsky region, Russian Federation
        • State Institution, Moscow City Oncology Hospital #62
    • Stavropol region,
      • Stavropol,, Stavropol region,, Russian Federation, 355047,
        • State Medical Institution "Stavropol Regional Clinical Oncology Center"
  • Serbia
      • Belgrade, Serbia, 11000
        • Institut za onkologiju i radiologiju Srbije, Klinika za medikalnu onkologiju
      • Kragujevac, Serbia, 34000
        • Klinički Bolnički Centar Kragujevac, Centar za onkologiju i radioterapiju
      • Niš, Serbia, 18000
        • Klinički Centar Niš, Klinika za onkologiju
      • Sremska Kamenica, Serbia, 21204
        • Institut za onkologiju Vojvodine, Klinika za operativnu onkologiju
  • Slovakia
      • Banska Bysterica, Slovakia, 975 17
        • Onkologicke oddelenie, FNsP F. D. Roosevelta
      • Bratilslava, Slovakia, 83310
        • Interne oddelenie, Narodny onkologicky ustav
      • Simferopol, Slovakia, 95017
        • Crimean Republicann Oncology Dispensary
  • Sweden
      • Göteborg, Sweden, 413 45
        • Divisionen för Onkologi , Sahlgrenska Universitetssjukhuset
      • Linköping, Sweden, 581 85
        • Onkologikliniken, Universitetssjukhuset Linköping
      • Lund, Sweden, 221 85
        • Onkologiska Kliniken, Universitetssjukhuset Lund
      • Umeå, Sweden, 901 85
        • Gyn-Onkologiska kliniken, Norrlands universitetssjukhus
      • Örebro, Sweden, 701 85
        • Kliniken för Gynekologisk Onkologi, Regionsjukhuset
  • Ukraine
      • Cherkassy, Ukraine, 18009
        • Cherkassy Regional Oncological Centre
      • Chernivtsy, Ukraine
        • Cherkassy Regional Oncological Centre
      • Dnepropetrovsk, Ukraine, 49100
        • KZ, City Clinical Hospital #19 City oncology Center
      • Dnipropetrovsk, Ukraine, 46102
        • Multi-profile clinical hospital#4
      • Donetsk, Ukraine, 83092
        • Donetsk Regional Antitumor Center
      • Kharkiv, Ukraine, 61024
        • "S.P. Grygoryev Institute of Medical Radiology of the Academy of Medical Science of Ukraine
      • Kherson, Ukraine, 73000
        • Kherson Reginal Oncological Center
      • Kiev, Ukraine, 03022
        • DU, National Institute of Cancer, Department of Oncogynecology
      • Kiev, Ukraine, 03115
        • Kiev City Oncology center
      • Lugansk, Ukraine, 91047
        • Lugansk Regional Oncology Center
      • Odessa, Ukraine
        • Odessa City Oncological Center
      • Sumy, Ukraine, 40005
        • Sumy Regional Onclolgy Center
      • Ternopil, Ukraine
        • Ternopil Regional Oncology Hospital
    • Bagautivska str. 1
      • Kyiv, Bagautivska str. 1, Ukraine, 04107
        • Kyiv Regional Oncology Center
    • Lisoparkivska str 4
      • Kharkiv, Lisoparkivska str 4, Ukraine, 610 70
        • Kharkiv Regional Clinical Oncology
    • Medychna str.17
      • Ivano-Frankivsk, 76018, Medychna str.17, Ukraine, 76018
        • Ivano-Frankivsk Regional Oncology Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Paclitaxel, micellar (Paclical®)
Drug: 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.
Active Comparator: Paclitaxel, CrEL (Taxol®)
Drug: 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oasmia Pharmaceutical AB

Investigators

  • Principal Investigator: Ignace Vergote, Prof., Division of Gynaecological Oncology, Department of Obstetrics and Gynaecology, University Hospitals Leuven, Belgium

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (Actual)

October 1, 2013

Study Completion (Actual)

October 1, 2013

Study Registration Dates

First Submitted

September 28, 2009

First Submitted That Met QC Criteria

October 1, 2009

First Posted (Estimate)

October 2, 2009

Study Record Updates

Last Update Posted (Estimate)

February 4, 2014

Last Update Submitted That Met QC Criteria

February 3, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OAS-07OVA

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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