AzTrials
AzTrials

Epithelial Ovarian CancerPhase 3NCT00989131

Study of Paclitaxel in Patients With Ovarian Cancer

A Phase 3 study testing Paclical® and Taxol® in people with Epithelial Ovarian Cancer and Primary Peritoneal Cancer, run by Oasmia Pharmaceutical AB at 84 sites in 16 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Paclical® and Taxol®
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
789 participants
Where
84 sitesin 16 countries
Study dates
Feb 2009to Oct 2013
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 15Show fewer
  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • 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)

Trial locations and contacts

84 sites in 16 countries.

84 sites in 16 countries

Russia26 sites

  • State Medical Institution, Arkhankelsk Regional Clinical Oncology Center

    Arkhangelsk, 163045

  • State Medical Institution, Altai Regional Oncology Center

    Barnaul, 65 60 49

  • Chelyabinsk Regional Clinical Oncology Center

    Chelyabinsk, 454087

  • Clinical Oncology Center

    Kazan', 420029

  • State Treatment and Prevention Institution, Kirov Regional Clinical Oncology Center

    Kirov, 610021

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

    Krasnodar, 350040

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

    Magnitogorsk, 455001

  • State Institution, Moscow City Oncology Hospital #62

    Moscow, Krasnogorsky Region

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

    Moscow, 115478

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

    Moscow, 121356

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

    Nizhny Novgorod, 603109

  • State Medical Institution of the Omsk Region, Clincial Oncology center

    Omsk, 644013

  • State Medical Institution "Orenburg Regional Clinical Oncology Center"

    Orenburg, 460021,

  • State Medicinal Institution, Reginal oncology center

    Penza, 440071

  • State Medical Institution "Republic Oncology Center"

    Petrozavodsk, 18500

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

    Pyatigorsk, 357500

  • State Medical Institution "Leningrad Regional Oncology Center"

    Saint Petersburg, 191104,

  • 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

  • St Petersburg State Medical Institution, City clinical oncology center

    Saint Petersburg, 198255

  • Samara Regional Clinical Oncology Center

    Samara, 443066

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

    Sochi, 354057

  • State Medical Institution "Stavropol Regional Clinical Oncology Center"

    Stavropol, Stavropol Kray, 355047,

  • State Medical Institution, Tambov Regional Oncology Center #2

    Tambov, 392013

  • State Medical Institution, Voronezh Regional Clinical Oncology Center

    Voronezh, 394000

  • State Medical Institution of the Yaroslavl, Region Clinical Oncology Center

    Yaroslavl, 150054

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

    Yekaterinburg, 620036

Other trials in Russia

Ukraine16 sites

  • Cherkassy Regional Oncological Centre

    Cherkassy, 18009

  • Cherkassy Regional Oncological Centre

    Chernivtsy

  • KZ, City Clinical Hospital #19 City oncology Center

    Dnipro, 49100

  • Multi-profile clinical hospital#4

    Dnipropetrovsk, 46102

  • Donetsk Regional Antitumor Center

    Donetsk, 83092

  • Ivano-Frankivsk Regional Oncology Center

    Ivano-Frankivsk, Medychna Str.17, 76018

  • Kharkiv Regional Clinical Oncology

    Kharkiv, Lisoparkivska Str 4, 610 70

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

    Kharkiv, 61024

  • Kherson Reginal Oncological Center

    Kherson, 73000

  • DU, National Institute of Cancer, Department of Oncogynecology

    Kiev, 03022

  • Kiev City Oncology center

    Kiev, 03115

  • Kyiv Regional Oncology Center

    Kyiv, Bagautivska Str. 1, 04107

  • Lugansk Regional Oncology Center

    Luhansk, 91047

  • Odessa City Oncological Center

    Odesa

  • Sumy Regional Onclolgy Center

    Sumy, 40005

  • Ternopil Regional Oncology Hospital

    Ternopil

Other trials in Ukraine

Hungary5 sites

  • Kaposi Mór Megyei Kórház, Onkológiai Tanszék

    Kaposvár, 7400

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

    Miskolc, 3526

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

    Nyíregyháza, 4400

  • Veszprém Megyei Csolnoky Ferenc Kórház-Rendelőintézet ZRT

    Veszprém, 8200

  • Zala Megyei Kórház, Onkológia

    Zalaegerszeg, 8900

Other trials in Hungary

Sweden5 sites

  • Divisionen för Onkologi , Sahlgrenska Universitetssjukhuset

    Gothenburg, 413 45

  • Onkologikliniken, Universitetssjukhuset Linköping

    Linköping, 581 85

  • Onkologiska Kliniken, Universitetssjukhuset Lund

    Lund, 221 85

  • Kliniken för Gynekologisk Onkologi, Regionsjukhuset

    Örebro, 701 85

  • Gyn-Onkologiska kliniken, Norrlands universitetssjukhus

    Umeå, 901 85

Other trials in Sweden

Belarus4 sites

  • Gomel Regional Clincial Oncology Center

    Homyel, 246012

  • Minsk City Clinical Oncology Hospital

    Minsk, 220013

  • Alexandrov National Cancer Center of Belarus

    Minsk, 223040

  • Vitebsk Regional Clinical Oncology Center

    Vitebsk, 210603

Other trials in Belarus

Czechia4 sites

  • Onkologická klinika, Fakultní nemocnice Královské Vinohrady

    Olomouc, 775 20

  • Onkologické a radioterapeutické oddělení, Fakultní nemocnice Plzeň

    Pilsen, 30100

  • Radioterapeutická a onkologická klinika, Fakultní nemocnice Královské Vinohrady

    Prague, 100 34

  • Ústav radiační onkologie, Fakultní nemocnice Na Bulovce

    Prague, 180 81

Other trials in Czechia

Romania4 sites

  • Cluj CF University Hospital

    Cluj-Napoca, 400015

  • Constanta Clinical County Hospital

    Constanța, 900591

  • MEDITECH SRL, ORIZONT Polyclinic

    Craiova, Dolj, 200535

  • County Clinical Emergency Hospital Oradea

    Oradea, Bihor County, 410167

Other trials in Romania

Serbia4 sites

  • Institut za onkologiju i radiologiju Srbije, Klinika za medikalnu onkologiju

    Belgrade, 11000

  • Institut za onkologiju Vojvodine, Klinika za operativnu onkologiju

    Kamenitz, 21204

  • Klinički Bolnički Centar Kragujevac, Centar za onkologiju i radioterapiju

    Kragujevac, 34000

  • Klinički Centar Niš, Klinika za onkologiju

    Niš, 18000

Other trials in Serbia

Bulgaria3 sites

  • Regional Oncology Dispensary

    Shumen, 9700

  • Hospital for a Active Treatment, Tsaritsa Yoanna

    Sofia, 1540

  • Regional Oncology Dispensary

    Stara Zagora, 6000

Other trials in Bulgaria

Croatia3 sites

  • Klinički Bolnički Centar Rijeka

    Rijeka, 51 000

  • Klinički Bolnički Centar Split

    Split, 21 000

  • Klinikčki Bolnički Centar Zagreb

    Zagreb, 10 000

Other trials in Croatia

Slovakia3 sites

  • Onkologicke oddelenie, FNsP F. D. Roosevelta

    Banska Bysterica, 975 17

  • Interne oddelenie, Narodny onkologicky ustav

    Bratilslava, 83310

  • Crimean Republicann Oncology Dispensary

    Simferopol, 95017

Other trials in Slovakia

Finland2 sites

  • Kuopion Yliopistollinen Sairaala, Naisten Klinikka

    Kuopio, 702 10

  • Turun Yliopistollinen Keskussairaala, Naisten Klinikka,

    Turku, 205 20

Other trials in Finland

Lithuania2 sites

  • Kaunas Medical University Hospital, Oncology Clinic

    Kaunas, 50009

  • Institute of Oncology, Vilnius University

    Vilnius, 08 660

Other trials in Lithuania

Belgium1 site

  • Department of gyneacology, Campus Gasthuisberg

    Leuven, 3000

Other trials in Belgium

Denmark1 site

  • Onkologisk Afdelning, Herning Sygehus

    Herning, 7400

Other trials in Denmark

Latvia1 site

  • Latvian Oncology Center of Riga Easter Hospital Ltd

    Riga, 1079

Other trials in Latvia

About this study

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)

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®.

Being tested
Paclical®, Taxol®
Keywords
Ovarian Cancer
Medical subject headings
Carcinoma, Ovarian Epithelial, Fallopian Tube Neoplasms, Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

  • 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.

Study groups in NCT00989131
Study groupRoleWhat they receive
Paclitaxel, micellar (Paclical®)ExperimentalNot described
Receives: Drug: Paclical®
Paclitaxel, CrEL (Taxol®)Active comparatorNot described
Receives: Drug: Taxol®

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression free survival (PFS).

  2. Change in Area under the curve of CA 125

  3. Incidence and severity of hypersensitivity reactions

Secondary outcomes (5)

  1. Nadir and time to nadir of CA 125 during and after treatment

  2. T½ of CA 125

  3. Safety and tolerability

  4. Response rate using CA 125

  5. Overall survival

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Oct 2009 (estimated)
  2. Study startFeb 2009
  3. Primary completionOct 2013
  4. Study completionOct 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
789 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00989131
Sponsor's protocol ID
OAS-07OVA
Status last verified
Feb 2014
First submitted
28 Sep 2009
Last updated
4 Feb 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 31826802

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Paclical® and Taxol® in people with Epithelial Ovarian Cancer and Primary Peritoneal Cancer, run by Oasmia Pharmaceutical AB at 84 sites in 16 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 84 sites in Russia, Ukraine, Hungary, Sweden, Belarus and 11 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression free survival (PFS).. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00989131, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2014.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in