check_circleStudy Completed

Ovarian Neoplasms

Bayer Identifier:

12007

ClinicalTrials.gov Identifier:

NCT00791778

EudraCT Number:

2008-004429-41

EU CT Number:

Not Available
Comparison of Nexavar/Placebo as maintenance therapy for patients with advanced Ovarian or primary Peritoneal cancer

Trial purpose

Comparison of Nexavar with a placebo as maintenance therapy for patients with advanced Ovarian or primary Peritoneal cancers in complete remission following surgery and one regimen of chemotherapy.

Key Participants Requirements

Sex

Both

Age

18 Years
  • - Histologically confirmed International Federation of Gynecology and Obstetrics (FIGO) stage (67) III or IV ovarian epithelial cancer or primary peritoneal cancer at presentation. Patients must have achieved a clinical complete response (disappearance of all clinical and radiological evidence of tumor) after only one regimen (4-6 cycles) of platinum and taxane-based standard chemotherapy received after tumor debulkment.
    - Normal serum CA125 (cancer-associated tumor marker) level within 7 days of first dose of sorafenib.
    - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
    - All scans used to document complete response must be done within 30 days prior to randomization.
    - Patients must be able to swallow and retain oral medication.
  • - Patients with any residual cancer tissue after the completion of chemotherapy detectable by standard Computed tomography (CT) or magnetic resonance imaging (MRI).
    - Prior local radiotherapy, neoadjuvant chemotherapy or intraperitoneal chemotherapy.
    - Histologic subtypes of ovarian cancer other than epithelial (i.e. sarcoma, lymphoma, germ cell).
    - Major surgery, open biopsy, or significant traumatic injury within 30 days prior to randomization.

Trial summary

Enrollment Goal
246
Trial Dates
November 2008 - December 2012
Phase
Phase 2
Could I Receive a placebo
Yes
Products
Nexavar (Sorafenib, BAY43-9006)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Georgia Health Sciences UniversityAugusta, 30912, United States
Completed
Centre Léon BérardLYON CEDEX, 39373, France
Completed
Institut Gustave Roussy - VillejuifVILLEJUIF, 94805, France
Completed
Centre Henry Kaplan / CHU TOURSTours, 37044, France
Completed
Szpiatal Kliniczny nr 1 Przemienienia PanskiegoPoznan, 61-878, Poland
Completed
Centrum Onkologii Instytut im. M. Sklodowskiej-CurieKrakow, 31-115, Poland
Completed
Bialostockie Centrum Onkologii im. M. Sklodowskiej-CurieBialystok, 15-027, Poland
Completed
Jichi Medical University HospitalShimotsuke, 329-0498, Japan
Completed
IRCCS Ist Europeo OncologiaMilano, 20141, Italy
Completed
Fondazione di Ricerca e Cura Giovanni Paolo IICampobasso, 00168, Italy
Completed
Hospital Clínico Universitario San CarlosMadrid, 28040, Spain
Completed
Hospital Universitario 12 de OctubreMadrid, 28041, Spain
Completed
Corporació Sanitària Parc TaulíSabadell, 08208, Spain
Completed
Princess Margaret Hospital-University Health NetworkToronto, M5G 2M9, Canada
Completed
Charité Campus Virchow-Klinikum (CVK)Berlin, 13353, Germany
Completed
Maine Medical Partners/Women's HealthScarborough, 04074, United States
Completed
Shands Jacksonville Medical CenterJacksonville, 32209, United States
Completed
Scripps Cancer CenterLa Jolla, 92037, United States
Completed
Centre François Baclesse - CLCC - CaenCAEN CEDEX 5, 14076, France
Completed
Centre PAUL PAPINANGERS cedex 9, 49933, France
Completed
Szpital Morski im. PCK Gdynskie Centrum OnkologiiGdynia, 81-519, Poland
Completed
Wielkopolskie Centrum OnkologiiPoznan, 61-866, Poland
Completed
Centrum Onkologii - Instytut im. M.Sklodowskiej-CurieWarszawa, 02-781, Poland
Completed
Centrum Onkologii Ziemi LubelskiejLublin, Poland
Completed
The Jikei University HospitalMinato-ku, 105-8471, Japan
Completed
The Cancer Institute Hospital of JFCRKoto-ku, 135-8550, Japan
Completed
Tokai University HospitalIsehara, 259-1193, Japan
Completed
The Jikei University of Medicine, Kashiwa HospitalKashiwa, 277-8567, Japan
Completed
CHUM - Hopital Notre-DameMontreal, H2L 4M1, Canada
Completed
Juravinski Cancer CentreHamilton, L8V 5C2, Canada
Completed
CU Saint-Luc/UZ St-LucBRUXELLES - BRUSSEL, 1200, Belgium
Completed
CH de Jolimont - Lobbes Site de JolimontLA LOUVIERE, 7100, Belgium
Completed
UZ AntwerpenEDEGEM, 2650, Belgium
Completed
UZ Leuven GasthuisbergLEUVEN, 3000, Belgium
Completed
Samsung Medical CenterSeoul, 135-710, Korea, Republic Of
Completed
Seoul National University HospitalSeoul, 110-744, Korea, Republic Of
Completed
Severance Hospital, Yonsei University College of MedicineSeoul, 120-752, Korea, Republic Of
Completed
Kuopion yliopistollinen sairaalaKuopio, FIN- 70211, Finland
Completed
Keski-Suomen keskussairaalaJyväskylä, FI-40620, Finland
Completed
Queen Mary HospitalHongKong, Hong Kong
Completed
National University HospitalSingapore, 119228, Singapore
Completed
Aichi Cancer Center HospitalNagoya, 464-8681, Japan
Completed
Università Cattolica del Sacro CuoreRoma, 00168, Italy
Completed
IRST Istituto Scientifico Romagnolo per studio e cura TumoriMeldola, 47014, Italy
Completed
Congregazione Figli Immacolata ConcezioneRoma, 00167, Italy
Completed
Hospital Universitario Virgen del RocíoSevilla, 41013, Spain
Completed
Hopsital Lucus AgustíLugo, 27003, Spain
Completed
London Regional Cancer ProgramLondon, N6A 4L6, Canada
Completed
AZ Sint-AugustinusWILRIJK, 2610, Belgium
Completed
Institut Jules Bordet/Jules Bordet InstituutBRUXELLES - BRUSSEL, 1000, Belgium
Completed
Academisch Ziekenhuis MaastrichtMaastricht, 6229 HX, Netherlands
Completed
HagaZiekenhuis, locatie LeyenburgDen Haag, 2545 CH, Netherlands
Completed
National Cancer CenterGyeonggi-do, 410-769, Korea, Republic Of
Completed
Ewha Womans University HospitalSeoul, 158-710, Korea, Republic Of
Completed
Asan Medical CenterSeoul, 138-736, Korea, Republic Of
Completed
Ajou University HospitalSowon, 443-721, Korea, Republic Of
Completed
Keimyung University Dongsan Medical CenterDaegu, 700-712, Korea, Republic Of
Completed
Gachon University Gil Medical CenterIncheon, 405-760, Korea, Republic Of
Completed
Queen Elizabeth HospitalHong Kong, Hong Kong
Completed
KK Women's and Children's HospitalSingapore, 229899, Singapore

Primary Outcome

  • Progression-free survival (PFS), based on radiological or pathologic assessment
    date_rangeTime Frame:
    From randomization of the first patient until 32.5 months later, assessed every 8 weeks
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    Safety Issue:
    No

Secondary Outcome

  • Time to first pathologic CA-125 (cancer-associated tumor marker) serum level
    date_rangeTime Frame:
    From randomization of the first patient until 32.5 months later, assessed every 8 weeks
    enhanced_encryption
    Safety Issue:
    No
  • Overall survival (OS)
    date_rangeTime Frame:
    From randomization of the first patient until 32.5 months later
    enhanced_encryption
    Safety Issue:
    No

Trial design

A Double-Blind, Randomized Phase II Study Evaluating the Efficacy and Safety of Sorafenib Compared to Placebo in Ovarian Epithelial Cancer or Primary Peritoneal Cancer Patients who have achieved a Complete Clinical Response after Standard Platinum/Taxane Containing Chemotherapy
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Double Blind
Assignment
Parallel Assignment
Trial Arms
2

Additional Information

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