Study of Paclitaxel in Patients With Ovarian Cancer

Fallopian Tube Cancer Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00989131
• Other study ID #: OAS-07OVA
• Status: Completed
• Phase: Phase 3
• First received: September 28, 2009
• Last updated: February 3, 2014
• Start date: February 2009
• Est. completion date: October 2013

Study information

• Verified date: February 2014
• Source: Oasmia Pharmaceutical AB
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belarus: Ministry of HealthBelgium: Federal Agency for Medicinal Products and Health ProductsBulgaria: Bulgarian Drug AgencyCroatia: Agency for Medicinal Product and Medical DevicesDenmark: Danish Medicines AgencyFinland: Finnish Medicines AgencyHungary: National Institute of PharmacyLatvia: State Agency of MedicinesLithuania: State Medicine Control Agency - Ministry of HealthRomania: National Medicines AgencyRussia: Ministry of Health of the Russian FederationSerbia and Montenegro: Agency for Drugs and Medicinal DevicesSlovakia: State Institute for Drug ControlSweden: Medical Products AgencyUkraine: State Pharmacological Center - Ministry of Health
• Study type: Interventional

Clinical Trial 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®.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 789
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Epithelial Ovarian Cancer
• Fallopian Tube Cancer
• Fallopian Tube Neoplasms
• Neoplasms, Glandular and Epithelial
• Ovarian Neoplasms
• Peritoneal Neoplasms
• Primary Peritoneal Cancer

Intervention

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.
• 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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Oasmia Pharmaceutical AB

Countries where clinical trial is conducted

Belarus,  Belgium,  Bulgaria,  Croatia,  Czech Republic,  Denmark,  Finland,  Hungary,  Latvia,  Lithuania,  Romania,  Russian Federation,  Serbia,  Slovakia,  Sweden,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression free survival (PFS).			No
Primary	Change in Area under the curve of CA 125
Primary	Incidence and severity of hypersensitivity reactions
Secondary	Nadir and time to nadir of CA 125 during and after treatment			No
Secondary	T½ of CA 125			No
Secondary	Safety and tolerability			Yes
Secondary	Response rate using CA 125			No
Secondary	Overall survival			No