Study of Paclitaxel in Patients With Ovarian Cancer

NCT00989131 | Completed Phase 3 DMC

• 1 other identifier: OAS-07OVA
• Study Type: interventional
• Target: 789
• Locations: 14 countries
• Sites: 79

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®.

Conditions

Epithelial Ovarian Cancer; Primary Peritoneal Cancer; Fallopian Tube Cancer

Keywords

Ovarian Cancer

Outcome Measures

Primary Outcomes (3)

• Progression free survival (PFS).

• Change in Area under the curve of CA 125

• Incidence and severity of hypersensitivity reactions

Secondary Outcomes (5)

• Nadir and time to nadir of CA 125 during and after treatment

• T½ of CA 125

• Safety and tolerability

• Response rate using CA 125

• Overall survival

Study Arms (2)

Paclitaxel, micellar (Paclical®)

EXPERIMENTAL

Drug: Paclical®

Paclitaxel, CrEL (Taxol®)

ACTIVE COMPARATOR

Drug: Taxol®

Interventions

Paclical® DRUG

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.

Paclitaxel, micellar (Paclical®)

Taxol® DRUG

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.

Paclitaxel, CrEL (Taxol®)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Oasmia Pharmaceutical AB: lead

Study Sites (84)

Gomel Regional Clincial Oncology Center

Homyel, 246012, Belarus

Location

Minsk City Clinical Oncology Hospital

Minsk, 220013, Belarus

Location

Alexandrov National Cancer Center of Belarus

Minsk, 223040, Belarus

Location

Vitebsk Regional Clinical Oncology Center

Vitebsk, 210603, Belarus

Location

Department of gyneacology, Campus Gasthuisberg

Leuven, 3000, Belgium

Location

Regional Oncology Dispensary

Shumen, 9700, Bulgaria

Location

Hospital for a Active Treatment, Tsaritsa Yoanna

Sofia, 1540, Bulgaria

Location

Regional Oncology Dispensary

Stara Zagora, 6000, Bulgaria

Location

Klinički Bolnički Centar Rijeka

Rijeka, 51 000, Croatia

Location

Klinički Bolnički Centar Split

Split, 21 000, Croatia

Location

Klinikčki Bolnički Centar Zagreb

Zagreb, 10 000, Croatia

Location

Onkologická klinika, Fakultní nemocnice Královské Vinohrady

Olomouc, 775 20, Czechia

Location

Onkologické a radioterapeutické oddělení, Fakultní nemocnice Plzeň

Pilsen, 30100, Czechia

Location

Radioterapeutická a onkologická klinika, Fakultní nemocnice Královské Vinohrady

Prague, 100 34, Czechia

Location

Ústav radiační onkologie, Fakultní nemocnice Na Bulovce

Prague, 180 81, Czechia

Location

Onkologisk Afdelning, Herning Sygehus

Herning, 7400, Denmark

Location

Kuopion Yliopistollinen Sairaala, Naisten Klinikka

Kuopio, 702 10, Finland

Location

Turun Yliopistollinen Keskussairaala, Naisten Klinikka,

Turku, 205 20, Finland

Location

Kaposi Mór Megyei Kórház, Onkológiai Tanszék

Kaposvár, 7400, Hungary

Location

B.-A.-Z. Megyei Kórház és Egyetemi Oktató Kórház, Észak-Kelet Magyarországi Regionális Klinikai Farmakológiai Központ

Miskolc, 3526, Hungary

Location

Szabolcs-Szatmár-Bereg Megyei Önkormányzat Jósa András Oktató Kórháza, Onkoradiológia

Nyíregyháza, 4400, Hungary

Location

Veszprém Megyei Csolnoky Ferenc Kórház-Rendelőintézet ZRT

Veszprém, 8200, Hungary

Location

Zala Megyei Kórház, Onkológia

Zalaegerszeg, 8900, Hungary

Location

Latvian Oncology Center of Riga Easter Hospital Ltd

Riga, 1079, Latvia

Location

Kaunas Medical University Hospital, Oncology Clinic

Kaunas, 50009, Lithuania

Location

Institute of Oncology, Vilnius University

Vilnius, 08 660, Lithuania

Location

County Clinical Emergency Hospital Oradea

Oradea, Bihor County, 410167, Romania

Location

MEDITECH SRL, ORIZONT Polyclinic

Craiova, Dolj, 200535, Romania

Location

Cluj CF University Hospital

Cluj-Napoca, 400015, Romania

Location

Constanta Clinical County Hospital

Constanța, 900591, Romania

Location

State Institution, Moscow City Oncology Hospital #62

Moscow, Krasnogorsky Region, Russia

Location

State Medical Institution "Stavropol Regional Clinical Oncology Center"

Stavropol, Stavropol Kray, 355047,, Russia

Location

State Medical Institution, Arkhankelsk Regional Clinical Oncology Center

Arkhangelsk, 163045, Russia

Location

State Medical Institution, Altai Regional Oncology Center

Barnaul, 65 60 49, Russia

Location

Chelyabinsk Regional Clinical Oncology Center

Chelyabinsk, 454087, Russia

Location

Clinical Oncology Center

Kazan', 420029, Russia

Location

State Treatment and Prevention Institution, Kirov Regional Clinical Oncology Center

Kirov, 610021, Russia

Location

State Medical Institution "Clinical Oncology Center #1" under the Ministry of Health of Krasnodar Region

Krasnodar, 350040, Russia

Location

State Medical Institution, Regional Oncology Center #2, Surgery department

Magnitogorsk, 455001, Russia

Location

N.N. Blokhin Cancere Research Center under the Russian Academy of Medical Sciences

Moscow, 115478, Russia

Location

Federal State Institution, Central Clinical Hospital with Outpatient Unit under the Russian Presidential Administration

Moscow, 121356, Russia

Location

Federal State Institution "Privolzhskiy District Medical Center of Federal Bio-medical Agency"

Nizhny Novgorod, 603109, Russia

Location

State Medical Institution of the Omsk Region, Clincial Oncology center

Omsk, 644013, Russia

Location

State Medical Institution "Orenburg Regional Clinical Oncology Center"

Orenburg, 460021,, Russia

Location

State Medicinal Institution, Reginal oncology center

Penza, 440071, Russia

Location

State Medical Institution "Republic Oncology Center"

Petrozavodsk, 18500, Russia

Location

Pyatigorsk Affiliate of State Medical Institution, Stavropol Regional Clinical Oncology Center

Pyatigorsk, 357500, Russia

Location

State Medical Institution "Leningrad Regional Oncology Center"

Saint Petersburg, 191104,, Russia

Location

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

Saint Petersburg, 197758, Russia

Location

St Petersburg State Medical Institution, City clinical oncology center

Saint Petersburg, 198255, Russia

Location

Samara Regional Clinical Oncology Center

Samara, 443066, Russia

Location

State Medical Institution, Oncology Center #2 under the Krasnodar Region Healthcare Department

Sochi, 354057, Russia

Location

State Medical Institution, Tambov Regional Oncology Center #2

Tambov, 392013, Russia

Location

State Medical Institution, Voronezh Regional Clinical Oncology Center

Voronezh, 394000, Russia

Location

State Medical Institution of the Yaroslavl, Region Clinical Oncology Center

Yaroslavl, 150054, Russia

Location

State Budget-funded Medical Institution of Sverdlovsk Region "Sverdlovsk Regional Oncology Center"

Yekaterinburg, 620036, Russia

Location

Institut za onkologiju i radiologiju Srbije, Klinika za medikalnu onkologiju

Belgrade, 11000, Serbia

Location

Institut za onkologiju Vojvodine, Klinika za operativnu onkologiju

Kamenitz, 21204, Serbia

Location

Klinički Bolnički Centar Kragujevac, Centar za onkologiju i radioterapiju

Kragujevac, 34000, Serbia

Location

Klinički Centar Niš, Klinika za onkologiju

Niš, 18000, Serbia

Location

Onkologicke oddelenie, FNsP F. D. Roosevelta

Banska Bysterica, 975 17, Slovakia

Location

Interne oddelenie, Narodny onkologicky ustav

Bratilslava, 83310, Slovakia

Location

Crimean Republicann Oncology Dispensary

Simferopol, 95017, Slovakia

Location

Divisionen för Onkologi , Sahlgrenska Universitetssjukhuset

Gothenburg, 413 45, Sweden

Location

Onkologikliniken, Universitetssjukhuset Linköping

Linköping, 581 85, Sweden

Location

Onkologiska Kliniken, Universitetssjukhuset Lund

Lund, 221 85, Sweden

Location

Kliniken för Gynekologisk Onkologi, Regionsjukhuset

Örebro, 701 85, Sweden

Location

Gyn-Onkologiska kliniken, Norrlands universitetssjukhus

Umeå, 901 85, Sweden

Location

Kyiv Regional Oncology Center

Kyiv, Bagautivska Str. 1, 04107, Ukraine

Location

Kharkiv Regional Clinical Oncology

Kharkiv, Lisoparkivska Str 4, 610 70, Ukraine

Location

Ivano-Frankivsk Regional Oncology Center

Ivano-Frankivsk, Medychna Str.17, 76018, Ukraine

Location

Cherkassy Regional Oncological Centre

Cherkassy, 18009, Ukraine

Location

Cherkassy Regional Oncological Centre

Chernivtsy, Ukraine

Location

KZ, City Clinical Hospital #19 City oncology Center

Dnipro, 49100, Ukraine

Location

Multi-profile clinical hospital#4

Dnipropetrovsk, 46102, Ukraine

Location

Donetsk Regional Antitumor Center

Donetsk, 83092, Ukraine

Location

"S.P. Grygoryev Institute of Medical Radiology of the Academy of Medical Science of Ukraine

Kharkiv, 61024, Ukraine

Location

Kherson Reginal Oncological Center

Kherson, 73000, Ukraine

Location

DU, National Institute of Cancer, Department of Oncogynecology

Kiev, 03022, Ukraine

Location

Kiev City Oncology center

Kiev, 03115, Ukraine

Location

Lugansk Regional Oncology Center

Luhansk, 91047, Ukraine

Location

Odessa City Oncological Center

Odesa, Ukraine

Location

Sumy Regional Onclolgy Center

Sumy, 40005, Ukraine

Location

Ternopil Regional Oncology Hospital

Ternopil, Ukraine

Location

Related Publications (1)

• 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.

  PMID: 31826802 DERIVED

MeSH Terms

Conditions

Carcinoma, Ovarian Epithelial; Fallopian Tube Neoplasms; Ovarian Neoplasms

Interventions

Paclitaxel

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Fallopian Tube Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Ignace Vergote, Prof.

  Division of Gynaecological Oncology, Department of Obstetrics and Gynaecology, University Hospitals Leuven, Belgium

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2009
• First Posted: October 2, 2009
• Study Start: February 1, 2009
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: February 4, 2014

Record last verified: 2014-02

Locations

LI (2); CZ (4); UA (16); BU (3); HU (5); RO (4); BE (4); DK (1); CR (3); FI (2); SE (5); SL (3); LA (1); RU (26)