Back to resultsComparison of Nexavar/Placebo as Maintenance Therapy for Patients With Advanced Ovarian or Primary Peritoneal Cancer
Primary Purpose
Ovarian Neoplasms
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Sorafenib (Nexavar, BAY43-9006)
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Ovarian Neoplasms focused on measuring Peritoneal Neoplasma
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Sorafenib (Nexavar, BAY43-9006)
Placebo
Arm Description
Participants received 2 sorafenib tablets (200 mg each) per oral twice daily (bid)
Participants received 2 matching placebo tablets per oral twice daily
Outcomes
Primary Outcome Measures
Progression-free Survival (PFS), Based on Radiological or Pathologic Assessment
Time from randomization to the first documented disease progression by radiological or pathologic assessment or death due to any cause whichever occurred first. For patients who had not progressed or died at the time of analysis, PFS was censored at the date of their last evaluable tumor scan.
Secondary Outcome Measures
Time to First Pathologic CA-125 (Cancer-associated Tumor Marker) Serum Level
Time from randomization to the first documented increase of CA-125 above the upper limit of normal. Patients without pathologic CA-125 increase at the time of analysis were censored at their last date of evaluation of CA-125.
Overall Survival (OS)
The OS time was measured from the date of randomization until the date of death due to any cause. Patients who were alive at the time of analysis were censored at the date of the last contact (last time the patient was known to be alive).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00791778
Brief Title
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
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Neoplasms
Keywords
Peritoneal Neoplasma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
246 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sorafenib (Nexavar, BAY43-9006)
Arm Type
Experimental
Arm Description
Participants received 2 sorafenib tablets (200 mg each) per oral twice daily (bid)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants received 2 matching placebo tablets per oral twice daily
Intervention Type
Drug
Intervention Name(s)
Sorafenib (Nexavar, BAY43-9006)
Intervention Description
Patients in Sorafenib arm will receive 2 Sorafenib tablets (200 mg each) twice a day and in continuous administration.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Patients in Placebo arm will receive 2 matching placebo tablets twice a day and in continuous administration.
Primary Outcome Measure Information:
Title
Progression-free Survival (PFS), Based on Radiological or Pathologic Assessment
Description
Time from randomization to the first documented disease progression by radiological or pathologic assessment or death due to any cause whichever occurred first. For patients who had not progressed or died at the time of analysis, PFS was censored at the date of their last evaluable tumor scan.
Time Frame
From randomization of the first patient until 32.5 months later, assessed every 8 weeks
Secondary Outcome Measure Information:
Title
Time to First Pathologic CA-125 (Cancer-associated Tumor Marker) Serum Level
Description
Time from randomization to the first documented increase of CA-125 above the upper limit of normal. Patients without pathologic CA-125 increase at the time of analysis were censored at their last date of evaluation of CA-125.
Time Frame
From randomization of the first patient until 32.5 months later, assessed every 8 weeks
Title
Overall Survival (OS)
Description
The OS time was measured from the date of randomization until the date of death due to any cause. Patients who were alive at the time of analysis were censored at the date of the last contact (last time the patient was known to be alive).
Time Frame
From randomization of the first patient until 32.5 months later
Other Pre-specified Outcome Measures:
Title
Functional Assessment of Cancer Therapy (FACT)/National Comprehensive Cancer Network (NCCN) Ovarian Symptom Index (FOSI) Total Score at Cycle 1/Baseline
Description
The FOSI is an 8-item index derived from the FACT-Ovarian Cancer (FACT-O) to measure symptom response to treatment for ovarian cancer. The FOSI total score ranges from 0 (severely symptomatic) to 32 (asymptomatic).
Time Frame
At Cycle 1 (4 weeks per Cycle)/baseline
Title
FOSI Total Score at Cycle 3
Description
The FOSI is an 8-item index derived from the FACT-Ovarian Cancer (FACT-O) to measure symptom response to treatment for ovarian cancer. The FOSI total score ranges from 0 (severely symptomatic) to 32 (asymptomatic).
Time Frame
At Cycle 3 (4 weeks per Cycle)
Title
Change From Baseline in FOSI Total Score at Cycle 3
Description
The FOSI is an 8-item index derived from the FACT-Ovarian Cancer (FACT-O) to measure symptom response to treatment for ovarian cancer. The change is calculated as score at Cycle 3 minus baseline score. The change in FOSI total score ranges from -32 (most deterioration from baseline) to 32 (most improvement from baseline).
Time Frame
Baseline and Cycle 3 (4 weeks per Cycle)
Title
FOSI Total Score at Cycle 5
Description
The FOSI is an 8-item index derived from the FACT-Ovarian Cancer (FACT-O) to measure symptom response to treatment for ovarian cancer. The FOSI total score ranges from 0 (severely symptomatic) to 32 (asymptomatic).
Time Frame
At Cycle 5 (4 weeks per Cycle)
Title
Change From Baseline in FOSI Total Score at Cycle 5
Description
The FOSI is an 8-item index derived from the FACT-Ovarian Cancer (FACT-O) to measure symptom response to treatment for ovarian cancer. The change is calculated as score at Cycle 5 minus baseline score. The change in FOSI total score ranges from -32 (most deterioration from baseline) to 32 (most improvement from baseline).
Time Frame
Baseline and Cycle 5 (4 weeks per Cycle)
Title
FOSI Total Score at End of Treatment
Description
The FOSI is an 8-item index derived from the FACT-Ovarian Cancer (FACT-O) to measure symptom response to treatment for ovarian cancer. The FOSI total score ranges from 0 (severely symptomatic) to 32 (asymptomatic).
Time Frame
At End of treatment (up to Cycle 33, 4 weeks per Cycle)
Title
Change From Baseline in FOSI Total Score at End of Treatment
Description
The FOSI is an 8-item index derived from the FACT-Ovarian Cancer (FACT-O) to measure symptom response to treatment for ovarian cancer. The change is calculated as score at End of treatment minus baseline score. The change in FOSI total score ranges from -32 (most deterioration from baseline) to 32 (most improvement from baseline).
Time Frame
Baseline and End of treatment (up to Cycle 33, 4 weeks per Cycle)
Title
EuroQol-5D (EQ-5D) Index Score at Cycle 1/Baseline
Description
The EQ-5D contains a descriptive system which measures 5 health dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. These five health dimensions are summarized into a single score, the EQ-5D index score which ranges from -0.594 (worst) to 1 (best) when the United Kingdom (UK) weights are applied.
Time Frame
At Cycle 1 (4 weeks per Cycle)/baseline
Title
EQ-5D Index Score at Cycle 3
Description
The EQ-5D contains a descriptive system which measures 5 health dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. These five health dimensions are summarized into a single score, the EQ-5D index score which ranges from -0.594 (worst) to 1 (best) when the United Kingdom (UK) weights are applied.
Time Frame
At Cycle 3 (4 weeks per Cycle)
Title
Change From Baseline in EQ-5D Index Score at Cycle 3
Description
The EQ-5D contains a descriptive system which measures 5 health dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. These five health dimensions are summarized into a single score, the EQ-5D index. The change is calculated as score at Cycle 3 minus baseline score. The change in EQ-5D index ranges from -1.594 (most deterioration from baseline) to 1.594 (most improvement from baseline).
Time Frame
Baseline and Cycle 3 (4 weeks per Cycle)
Title
EQ-5D Index Score at Cycle 5
Description
The EQ-5D contains a descriptive system which measures 5 health dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. These five health dimensions are summarized into a single score, the EQ-5D index score which ranges from -0.594 (worst) to 1 (best) when the United Kingdom (UK) weights are applied.
Time Frame
At Cycle 5 (4 weeks per Cycle)
Title
Change From Baseline in EQ-5D Index Score at Cycle 5
Description
The EQ-5D contains a descriptive system which measures 5 health dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. These five health dimensions are summarized into a single score, the EQ-5D index. The change is calculated as score at Cycle 5 minus baseline score. The change in EQ-5D index ranges from -1.594 (most deterioration from baseline) to 1.594 (most improvement from baseline).
Time Frame
Baseline and Cycle 5 (4 weeks per Cycle)
Title
EQ-5D Index Score at End of Treatment
Description
The EQ-5D contains a descriptive system which measures 5 health dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. These five health dimensions are summarized into a single score, the EQ-5D index score which ranges from -0.594 (worst) to 1 (best) when the United Kingdom (UK) weights are applied.
Time Frame
At End of treatment (up to Cycle 33, 4 weeks per Cycle)
Title
Change From Baseline in EQ-5D Index Score at End of Treatment
Description
The EQ-5D contains a descriptive system which measures 5 health dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. These five health dimensions are summarized into a single score, the EQ-5D index. The change is calculated as score at End of treatment minus baseline score. The change in EQ-5D index ranges from -1.594 (most deterioration from baseline) to 1.594 (most improvement from baseline).
Time Frame
Baseline and End of treatment (up to Cycle 33, 4 weeks per Cycle)
Title
EQ-5D Visual Analogue Scale (VAS) Score at Cycle 1/Baseline
Description
The EQ-5D also contains a VAS, which records the respondent's self-rated health status on a vertical graduated scale. The scale ranges from 0 (worst imaginable health state) to 100 (best imaginable health state).
Time Frame
At Cycle 1 (4 weeks per Cycle)/baseline
Title
EQ-5D VAS Score at Cycle 3
Description
The EQ-5D also contains a VAS, which records the respondent's self-rated health status on a vertical graduated scale. The scale ranges from 0 (worst imaginable health state) to 100 (best imaginable health state).
Time Frame
At Cycle 3 (4 weeks per Cycle)
Title
Change From Baseline in EQ-5D VAS Score at Cycle 3
Description
The EQ-5D also contains a VAS, which records the respondent's self-rated health status on a vertical graduated scale. The change is calculated as score at Cycle 3 minus baseline score. The change in EQ-5D VAS ranges from -100 (most deterioration from baseline) to 100 (most improvement from baseline).
Time Frame
Baseline and Cycle 3 (4 weeks per Cycle)
Title
EQ-5D VAS Score at Cycle 5
Description
The EQ-5D also contains a VAS, which records the respondent's self-rated health status on a vertical graduated scale. The scale ranges from 0 (worst imaginable health state) to 100 (best imaginable health state).
Time Frame
At Cycle 5 (4 weeks per Cycle)
Title
Change From Baseline in EQ-5D VAS Score at Cycle 5
Description
The EQ-5D also contains a VAS, which records the respondent's self-rated health status on a vertical graduated scale. The change is calculated as score at Cycle 5 minus baseline score. The change in EQ-5D VAS ranges from -100 (most deterioration from baseline) to 100 (most improvement from baseline).
Time Frame
Baseline and Cycle 5 (4 weeks per Cycle)
Title
EQ-5D VAS Score at End of Treatment
Description
The EQ-5D also contains a VAS, which records the respondent's self-rated health status on a vertical graduated scale. The scale ranges from 0 (worst imaginable health state) to 100 (best imaginable health state).
Time Frame
At End of treatment (up to Cycle 33, 4 weeks per Cycle)
Title
Change From Baseline in EQ-5D VAS Score at End of Treatment
Description
The EQ-5D also contains a VAS, which records the respondent's self-rated health status on a vertical graduated scale. The change is calculated as score at End of treatment minus baseline score. The change in EQ-5D VAS ranges from -100 (most deterioration from baseline) to 100 (most improvement from baseline).
Time Frame
Baseline and End of treatment (up to Cycle 33, 4 weeks per Cycle)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
City
Scarborough
State/Province
Maine
ZIP/Postal Code
04074
Country
United States
City
Bruxelles - Brussel
ZIP/Postal Code
1000
Country
Belgium
City
Bruxelles - Brussel
ZIP/Postal Code
1200
Country
Belgium
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
City
La Louviere
ZIP/Postal Code
7100
Country
Belgium
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
City
Wilrijk
ZIP/Postal Code
2610
Country
Belgium
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V 5C2
Country
Canada
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4L6
Country
Canada
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L 4M1
Country
Canada
City
Jyväskylä
ZIP/Postal Code
FI-40620
Country
Finland
City
Kuopio
ZIP/Postal Code
FIN- 70211
Country
Finland
City
ANGERS cedex 9
ZIP/Postal Code
49933
Country
France
City
Caen Cedex 5
ZIP/Postal Code
14076
Country
France
City
Lyon Cedex
ZIP/Postal Code
39373
Country
France
City
Tours
ZIP/Postal Code
37044
Country
France
City
Villejuif
ZIP/Postal Code
94805
Country
France
City
Berlin
ZIP/Postal Code
13353
Country
Germany
City
Hong Kong
Country
Hong Kong
City
HongKong
Country
Hong Kong
City
Meldola
State/Province
Forlì
ZIP/Postal Code
47014
Country
Italy
City
Campobasso
ZIP/Postal Code
00168
Country
Italy
City
Milano
ZIP/Postal Code
20141
Country
Italy
City
Roma
ZIP/Postal Code
00167
Country
Italy
City
Roma
ZIP/Postal Code
00168
Country
Italy
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
464-8681
Country
Japan
City
Kashiwa
State/Province
Chiba
ZIP/Postal Code
277-8567
Country
Japan
City
Isehara
State/Province
Kanagawa
ZIP/Postal Code
259-1193
Country
Japan
City
Shimotsuke
State/Province
Tochigi
ZIP/Postal Code
329-0498
Country
Japan
City
Koto-ku
State/Province
Tokyo
ZIP/Postal Code
135-8550
Country
Japan
City
Minato-ku
State/Province
Tokyo
ZIP/Postal Code
105-8471
Country
Japan
City
Seoul
State/Province
Seoul Teugbyeolsi
ZIP/Postal Code
110-744
Country
Korea, Republic of
City
Daegu
ZIP/Postal Code
700-712
Country
Korea, Republic of
City
Gyeonggi-do
ZIP/Postal Code
410-769
Country
Korea, Republic of
City
Incheon
ZIP/Postal Code
405-760
Country
Korea, Republic of
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
City
Seoul
ZIP/Postal Code
158-710
Country
Korea, Republic of
City
Sowon
ZIP/Postal Code
443-721
Country
Korea, Republic of
City
Den Haag
ZIP/Postal Code
2545 CH
Country
Netherlands
City
Maastricht
ZIP/Postal Code
6229 HX
Country
Netherlands
City
Bialystok
ZIP/Postal Code
15-027
Country
Poland
City
Gdynia
ZIP/Postal Code
81-519
Country
Poland
City
Krakow
ZIP/Postal Code
31-115
Country
Poland
City
Lublin
Country
Poland
City
Poznan
ZIP/Postal Code
61-866
Country
Poland
City
Poznan
ZIP/Postal Code
61-878
Country
Poland
City
Warszawa
ZIP/Postal Code
02-781
Country
Poland
City
Singapore
ZIP/Postal Code
119228
Country
Singapore
City
Singapore
ZIP/Postal Code
229899
Country
Singapore
City
Sabadell
State/Province
Barcelona
ZIP/Postal Code
08208
Country
Spain
City
Lugo
ZIP/Postal Code
27003
Country
Spain
City
Madrid
ZIP/Postal Code
28040
Country
Spain
City
Madrid
ZIP/Postal Code
28041
Country
Spain
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
23591401
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.
Results Reference
result
Links:
URL
http://www.clinicaltrialsregister.eu/
Description
Click here to find information about studies related to Bayer Healthcare products conducted in Europe
Learn more about this trial
Comparison of Nexavar/Placebo as Maintenance Therapy for Patients With Advanced Ovarian or Primary Peritoneal Cancer
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