Clinical trial NCT00791778: Comparison of Nexavar/Placebo as Maintenance Therapy for Patients With Advanced Ovarian or Primary Peritoneal Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ovarian Neoplasms
Keywords: Peritoneal Neoplasma
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2008-11-17
Enrollment: 246
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Progression-free Survival (PFS), Based on Radiological or Pathologic Assessment
timeFrame: From randomization of the first patient until 32.5 months later, assessed every 8 weeks
Secondary outcomes:
measure: Time to First Pathologic CA-125 (Cancer-associated Tumor Marker) Serum Level
timeFrame: From randomization of the first patient until 32.5 months later, assessed every 8 weeks
measure: Overall Survival (OS)
timeFrame: From randomization of the first patient until 32.5 months later
Other outcomes:
measure: Functional Assessment of Cancer Therapy (FACT)/National Comprehensive Cancer Network (NCCN) Ovarian Symptom Index (FOSI) Total Score at Cycle 1/Baseline
timeFrame: At Cycle 1 (4 weeks per Cycle)/baseline
measure: FOSI Total Score at Cycle 3
timeFrame: At Cycle 3 (4 weeks per Cycle)
measure: Change From Baseline in FOSI Total Score at Cycle 3
timeFrame: Baseline and Cycle 3 (4 weeks per Cycle)
measure: FOSI Total Score at Cycle 5
timeFrame: At Cycle 5 (4 weeks per Cycle)
measure: Change From Baseline in FOSI Total Score at Cycle 5
timeFrame: Baseline and Cycle 5 (4 weeks per Cycle)
measure: FOSI Total Score at End of Treatment
timeFrame: At End of treatment (up to Cycle 33, 4 weeks per Cycle)
measure: Change From Baseline in FOSI Total Score at End of Treatment
timeFrame: Baseline and End of treatment (up to Cycle 33, 4 weeks per Cycle)
measure: EuroQol-5D (EQ-5D) Index Score at Cycle 1/Baseline
timeFrame: At Cycle 1 (4 weeks per Cycle)/baseline
measure: EQ-5D Index Score at Cycle 3
timeFrame: At Cycle 3 (4 weeks per Cycle)
measure: Change From Baseline in EQ-5D Index Score at Cycle 3
timeFrame: Baseline and Cycle 3 (4 weeks per Cycle)
measure: EQ-5D Index Score at Cycle 5
timeFrame: At Cycle 5 (4 weeks per Cycle)
measure: Change From Baseline in EQ-5D Index Score at Cycle 5
timeFrame: Baseline and Cycle 5 (4 weeks per Cycle)
measure: EQ-5D Index Score at End of Treatment
timeFrame: At End of treatment (up to Cycle 33, 4 weeks per Cycle)
measure: Change From Baseline in EQ-5D Index Score at End of Treatment
timeFrame: Baseline and End of treatment (up to Cycle 33, 4 weeks per Cycle)
measure: EQ-5D Visual Analogue Scale (VAS) Score at Cycle 1/Baseline
timeFrame: At Cycle 1 (4 weeks per Cycle)/baseline
measure: EQ-5D VAS Score at Cycle 3
timeFrame: At Cycle 3 (4 weeks per Cycle)
measure: Change From Baseline in EQ-5D VAS Score at Cycle 3
timeFrame: Baseline and Cycle 3 (4 weeks per Cycle)
measure: EQ-5D VAS Score at Cycle 5
timeFrame: At Cycle 5 (4 weeks per Cycle)
measure: Change From Baseline in EQ-5D VAS Score at Cycle 5
timeFrame: Baseline and Cycle 5 (4 weeks per Cycle)
measure: EQ-5D VAS Score at End of Treatment
timeFrame: At End of treatment (up to Cycle 33, 4 weeks per Cycle)
measure: Change From Baseline in EQ-5D VAS Score at End of Treatment
timeFrame: Baseline and End of treatment (up to Cycle 33, 4 weeks per Cycle)
Locations:
city: La Jolla
country: United States
state: California
city: Jacksonville
country: United States
state: Florida
city: Augusta
country: United States
state: Georgia
city: Scarborough
country: United States
state: Maine
city: Bruxelles - Brussel
country: Belgium
city: Bruxelles - Brussel
country: Belgium
city: Edegem
country: Belgium
city: La Louviere
country: Belgium
city: Leuven
country: Belgium
city: Wilrijk
country: Belgium
city: Hamilton
country: Canada
state: Ontario
city: London
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Montreal
country: Canada
state: Quebec
city: Jyväskylä
country: Finland
city: Kuopio
country: Finland
city: ANGERS cedex 9
country: France
city: Caen Cedex 5
country: France
city: Lyon Cedex
country: France
city: Tours
country: France
city: Villejuif
country: France
city: Berlin
country: Germany
city: Hong Kong
country: Hong Kong
city: HongKong
country: Hong Kong
city: Meldola
country: Italy
state: Forlì
city: Campobasso
country: Italy
city: Milano
country: Italy
city: Roma
country: Italy
city: Roma
country: Italy
city: Nagoya
country: Japan
state: Aichi
city: Kashiwa
country: Japan
state: Chiba
city: Isehara
country: Japan
state: Kanagawa
city: Shimotsuke
country: Japan
state: Tochigi
city: Koto-ku
country: Japan
state: Tokyo
city: Minato-ku
country: Japan
state: Tokyo
city: Seoul
country: Korea, Republic of
state: Seoul Teugbyeolsi
city: Daegu
country: Korea, Republic of
city: Gyeonggi-do
country: Korea, Republic of
city: Incheon
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Sowon
country: Korea, Republic of
city: Den Haag
country: Netherlands
city: Maastricht
country: Netherlands
city: Bialystok
country: Poland
city: Gdynia
country: Poland
city: Krakow
country: Poland
city: Lublin
country: Poland
city: Poznan
country: Poland
city: Poznan
country: Poland
city: Warszawa
country: Poland
city: Singapore
country: Singapore
city: Singapore
country: Singapore
city: Sabadell
country: Spain
state: Barcelona
city: Lugo
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Sevilla
country: Spain
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: Herzog TJ, Scambia G, Kim BG, Lhomme C, Markowska J, Ray-Coquard I, Sehouli J, Colombo N, Shan M, Petrenciuc O, Oza A. A randomized phase II trial of maintenance therapy with Sorafenib in front-line ovarian carcinoma. Gynecol Oncol. 2013 Jul;130(1):25-30. doi: 10.1016/j.ygyno.2013.04.011. Epub 2013 Apr 13.