Study of Paclitaxel in Patients With Ovarian Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Oasmia Pharmaceutical AB
ClinicalTrials.gov Identifier:
NCT00989131
First received: September 28, 2009
Last updated: February 3, 2014
Last verified: February 2014
  Purpose

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®.


Condition Intervention Phase
Epithelial Ovarian Cancer
Primary Peritoneal Cancer
Fallopian Tube Cancer
Drug: Paclical®
Drug: Taxol®
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Oasmia Pharmaceutical AB:

Primary Outcome Measures:
  • Progression free survival (PFS). [ Designated as safety issue: No ]
  • 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 [ Designated as safety issue: No ]
  • T½ of CA 125 [ Designated as safety issue: No ]
  • Safety and tolerability [ Designated as safety issue: Yes ]
  • Response rate using CA 125 [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]

Enrollment: 789
Study Start Date: February 2009
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00989131

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

No publications provided

Responsible Party: Oasmia Pharmaceutical AB
ClinicalTrials.gov Identifier: NCT00989131     History of Changes
Other Study ID Numbers: OAS-07OVA
Study First Received: September 28, 2009
Last Updated: February 3, 2014
Health Authority: Belarus: Ministry of Health
Belgium: Federal Agency for Medicinal Products and Health Products
Bulgaria: Bulgarian Drug Agency
Croatia: Agency for Medicinal Product and Medical Devices
Denmark: Danish Medicines Agency
Finland: Finnish Medicines Agency
Hungary: National Institute of Pharmacy
Latvia: State Agency of Medicines
Lithuania: State Medicine Control Agency - Ministry of Health
Romania: National Medicines Agency
Russia: Ministry of Health of the Russian Federation
Serbia and Montenegro: Agency for Drugs and Medicinal Devices
Slovakia: State Institute for Drug Control
Sweden: Medical Products Agency
Ukraine: State Pharmacological Center - Ministry of Health

Keywords provided by Oasmia Pharmaceutical AB:
Ovarian Cancer

Additional relevant MeSH terms:
Ovarian Neoplasms
Fallopian Tube Neoplasms
Peritoneal Neoplasms
Neoplasms, Glandular and Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Fallopian Tube Diseases
Abdominal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Neoplasms by Histologic Type
Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 30, 2014