Back to resultsA Study of the Addition of Avastin (Bevacizumab) to Carboplatin and Paclitaxel Therapy in Patients With Ovarian Cancer
Primary Purpose
Ovarian Cancer
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Paclitaxel
Bevacizumab
Carboplatin
Sponsored by
About this trial
This is an interventional treatment trial for Ovarian Cancer
Eligibility Criteria
Inclusion Criteria:
- Histologically confirmed epithelial ovarian carcinoma, fallopian tube carcinoma, primary peritoneal carcinoma or clear cell carcinoma or carcinosarcoma. Participants with recurrent ovarian cancer who have been previously treated with surgery alone for their early stage disease are eligible.
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0, 1 or 2
- Life expectancy greater than or equal to (>=3) months
Exclusion Criteria:
- Participants with non-epithelial ovarian cancer, ovarian tumors with low malignant potential (i.e., borderline tumors), or synchronous primary endometrial carcinoma
- Previous systemic therapy for ovarian cancer. Prior neo-adjuvant chemotherapy is allowed
- Planned intraperitoneal cytotoxic chemotherapy
- Radiotherapy within 28 days of Day 1, Cycle 1
- Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to first dose of Avastin
- History or evidence of National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Grade >=1 arterial thromboembolic event or Grade >=3 venous thromboembolic event within 6 months prior to enrollment
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Bevacizumab + Paclitaxel + Carboplatin
Arm Description
Participants will receive bevacizumab 15 mg/kg IV on Day 1 every 3 weeks from Cycle 1 to Cycle 36 (initially concurrent with chemotherapy, then continued as a single agent following the completion of chemotherapy), or until protocol defined disease progression or until unacceptable toxicity (whichever occurred first). Participants will receive paclitaxel 175 mg/m^2 IV on Day 1 every 3 weeks or 80 mg/m^2 IV every week and carboplatin (AUC 5-6) IV on Day 1 every 3 weeks for a minimum of 4 and maximum of 8 cycles (including up to 4 pre-surgical cycles), or until protocol defined disease progression, or unacceptable toxicity (whichever occurred first).
Outcomes
Primary Outcome Measures
Percentage of Participants With at Least One Adverse Event (AE)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
Secondary Outcome Measures
Progression-Free Survival (PFS)
PFS was defined as the time between the date of first administration of any study treatment and the date of first documented protocol-defined disease progression (that is [i.e.], radiologically by Response Evaluation Criteria In Solid Tumors [RECIST], clinical, or symptomatic) or death, whichever occurred first. Participants who had neither progressed nor died at the time of data cut-off (07 December 2014), or participants who were withdrawn from study, or lost to follow-up without documented progression, were censored. Kaplan-Meier estimation was used for median time to PFS.
Percentage of Participants Achieving Best Overall Response of Complete Response (CR) or Partial Response (PR) According to RECIST Version 1.0
Best overall response (BOR) according to RECIST Version 1.0 was categorized as: CR, PR, progressive disease (PD), stable disease (SD). CR: disappearance of all target lesions and non-target lesions. PR: >=30% decrease in sum of the longest diameters (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST associated to non-progressive disease response for non-target lesions. PD: Natural progression or deterioration of the malignancy under study (including new sites of metastasis). SD: neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum longest diameter since the treatment started. Participants with a BOR of CR and PR were defined as responders, while participants with a BOR of SD, PD, or unable to assess were defined as non-responders.
Percentage of Participants Achieving an Overall Response by 50% Carcinoma Antigen 125 (CA-125) Response Criteria
CA-125 responders: Participants with the value of CA-125 reduced by at least 50% and confirmed with a consecutive CA-125 assessment performed at an interval of at least 28 days. Overall response according to CA-125 was only evaluated for participants with a pre-treatment CA-125 within 3 days prior to start of any study treatment of at least twice the upper limit of normal (ULN).
Percentage of Participants Achieving an Overall Response by RECIST Version 1.0 and/or 50% CA-125 Response Criteria
Overall response was only evaluated for participants who were evaluable according to RECIST v1.0 with a measurable disease at baseline and/or according to CA-125 with a pre-treatment CA-125 within 3 days prior to start of any study treatment of at least twice the ULN. RECIST responders: Participants achieving an overall response of CR (disappearance of all target lesions and non-target lesions) or PR (>=30% decrease in sum of the LD of the target lesions taking as a reference the baseline sum LD according to RECIST associated to non-progressive disease response for non target lesions). CA-125 responders: Participants with the value of CA-125 reduced by at least 50% and confirmed with a consecutive CA-125 assessment performed at an interval of at least 28 days.
Duration of Objective Response (DOR)
DOR was defined as the time from the first documented response (CR or PR per RECIST v1.0), to the first documented protocol-defined disease progression (i.e., radiologically by RECIST, clinical, or symptomatic) or death, whichever occurred first. Participants who had neither progressed nor died at the time of data cut-off (07 December 2014), or participants who were withdrawn from study, or lost to follow-up without documented progression, were censored. RECIST responders: Participants achieving an overall response of CR (disappearance of all target lesions and non-target lesions) or PR (>=30% decrease in sum of the LD of the target lesions taking as a reference the baseline sum LD according to RECIST associated to non-progressive disease response for non-target lesions). Disease progression: Natural progression or deterioration of the malignancy under study (including new sites of metastasis).
Overall Survival (OS)
OS was defined as the time from the date of the first administration of any study treatment to the date of death, regardless of the cause of death. Participants without the event of death were censored at the last date in the study, defined as the latest date of the following: the date of first administration of study treatment, date of last study treatment, date of last visit, or date last known to be alive. Kaplan-Meier estimation was used for OS.
Biological Progression-free Interval
Biological progression-free interval is defined as the interval from the date of the first administration of any study treatment to the date of the first documented serial elevation of the ovarian cancer mucin CA-125. More precisely, this is defined as the first documented increase in CA-125 levels as follows: (1) CA-125 greater than or equal to 2 times the upper level of normal (ULN) on 2 occasions at least 1 week apart (for participants with CA-125 within normal range pre-treatment) or (2) CA-125 greater than or equal to 2 times the ULN on 2 occasions at least 1 week apart (for participants with elevated CA-125 pre-treatment and initial normalization of CA-125 on-treatment) or (3) CA-125 greater than or equal to 2 times the nadir value, which is the lowest observed CA-125 value per participant on 2 occasions at least 1 week apart (for participants with elevated CA-125 pre-treatment which never normalized).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01239732
Brief Title
A Study of the Addition of Avastin (Bevacizumab) to Carboplatin and Paclitaxel Therapy in Patients With Ovarian Cancer
Official Title
Global Study to Assess the Addition of Bevacizumab to Carboplatin and Paclitaxel as Front-line Treatment of Epithelial Ovarian Cancer, Fallopian Tube Carcinoma or Primary Peritoneal Carcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
5. Study Description
Brief Summary
This open-label, non-comparative, multi-center study will assess the safety profile and efficacy of Avastin (bevacizumab) when added to carboplatin and paclitaxel therapy in participants with epithelial ovarian cancer, fallopian tube carcinoma or primary peritoneal carcinoma. Participants will receive 15 milligrams/kilogram (mg/kg) Avastin intravenously (IV) on Day 1 of every cycle for up to 36 cycles of 3 weeks each, carboplatin (area under the plasma concentration-time curve [AUC] 5-6 mg/ml/min) on Day 1 every 3 weeks for a maximum of 8 cycles and paclitaxel 175 milligram per square meter (mg/m^2) on Day 1 every 3 weeks or 80 mg/m^2 every week for a maximum of 8 cycles. The anticipated time on study drug will be 108 weeks or until disease progression or unacceptable toxicity.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1021 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bevacizumab + Paclitaxel + Carboplatin
Arm Type
Experimental
Arm Description
Participants will receive bevacizumab 15 mg/kg IV on Day 1 every 3 weeks from Cycle 1 to Cycle 36 (initially concurrent with chemotherapy, then continued as a single agent following the completion of chemotherapy), or until protocol defined disease progression or until unacceptable toxicity (whichever occurred first). Participants will receive paclitaxel 175 mg/m^2 IV on Day 1 every 3 weeks or 80 mg/m^2 IV every week and carboplatin (AUC 5-6) IV on Day 1 every 3 weeks for a minimum of 4 and maximum of 8 cycles (including up to 4 pre-surgical cycles), or until protocol defined disease progression, or unacceptable toxicity (whichever occurred first).
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Intervention Description
175 mg/m^2 on Day 1 every 3 weeks or at a dose of 80 mg/m^2 every week for a minimum of 4 cycles and not more than 8 cycles or until disease progression or unacceptable toxicity, whichever occurs first
Intervention Type
Drug
Intervention Name(s)
Bevacizumab
Other Intervention Name(s)
Avastin
Intervention Description
15 mg/kg intravenously on Day 1 of every cycle for up to 36 cycles of 3 weeks each or until disease progression or unacceptable toxicity, whichever occurs first
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Intervention Description
AUC 5-6 mg/ml/min on Day 1 every 3 weeks for a minimum of 4 cycles and not more than 8 cycles or until disease progression or unacceptable toxicity, whichever occurs first
Primary Outcome Measure Information:
Title
Percentage of Participants With at Least One Adverse Event (AE)
Description
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
Time Frame
Day 1 up to 30 days after last dose of study treatment (until data cutoff 07 December 2014, up to 4 years)
Secondary Outcome Measure Information:
Title
Progression-Free Survival (PFS)
Description
PFS was defined as the time between the date of first administration of any study treatment and the date of first documented protocol-defined disease progression (that is [i.e.], radiologically by Response Evaluation Criteria In Solid Tumors [RECIST], clinical, or symptomatic) or death, whichever occurred first. Participants who had neither progressed nor died at the time of data cut-off (07 December 2014), or participants who were withdrawn from study, or lost to follow-up without documented progression, were censored. Kaplan-Meier estimation was used for median time to PFS.
Time Frame
Day 1, at end of Cycles 3 and 6, then every 6 cycles while receiving bevacizumab, and then at bevacizumab cessation, every 26 weeks after cessation of bevacizumab until disease progression or death until data cutoff 07 December 2014, up to 4 years
Title
Percentage of Participants Achieving Best Overall Response of Complete Response (CR) or Partial Response (PR) According to RECIST Version 1.0
Description
Best overall response (BOR) according to RECIST Version 1.0 was categorized as: CR, PR, progressive disease (PD), stable disease (SD). CR: disappearance of all target lesions and non-target lesions. PR: >=30% decrease in sum of the longest diameters (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST associated to non-progressive disease response for non-target lesions. PD: Natural progression or deterioration of the malignancy under study (including new sites of metastasis). SD: neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum longest diameter since the treatment started. Participants with a BOR of CR and PR were defined as responders, while participants with a BOR of SD, PD, or unable to assess were defined as non-responders.
Time Frame
Day 1, at end of Cycles 3 and 6, then every 6 cycles while receiving bevacizumab, and then at bevacizumab cessation, every 26 weeks (Q26W) after cessation of bevacizumab until disease progression or death until data cutoff 07 December 2014, up to 4 years
Title
Percentage of Participants Achieving an Overall Response by 50% Carcinoma Antigen 125 (CA-125) Response Criteria
Description
CA-125 responders: Participants with the value of CA-125 reduced by at least 50% and confirmed with a consecutive CA-125 assessment performed at an interval of at least 28 days. Overall response according to CA-125 was only evaluated for participants with a pre-treatment CA-125 within 3 days prior to start of any study treatment of at least twice the upper limit of normal (ULN).
Time Frame
3 days prior to Day 1 of every cycle, then every 6 weeks (Q6W) during the first year, every 3 months (Q3M) in the second and third year, every 6 months (Q6M) in the fourth year of the study (until data cutoff 07 December 2014, up to 4 years)
Title
Percentage of Participants Achieving an Overall Response by RECIST Version 1.0 and/or 50% CA-125 Response Criteria
Description
Overall response was only evaluated for participants who were evaluable according to RECIST v1.0 with a measurable disease at baseline and/or according to CA-125 with a pre-treatment CA-125 within 3 days prior to start of any study treatment of at least twice the ULN. RECIST responders: Participants achieving an overall response of CR (disappearance of all target lesions and non-target lesions) or PR (>=30% decrease in sum of the LD of the target lesions taking as a reference the baseline sum LD according to RECIST associated to non-progressive disease response for non target lesions). CA-125 responders: Participants with the value of CA-125 reduced by at least 50% and confirmed with a consecutive CA-125 assessment performed at an interval of at least 28 days.
Time Frame
RECIST: Day 1, at end of Cycles 3 and 6, then every 6 cycles, at bevacizumab cessation, Q26W after cessation; CA-125: 3 days before Day 1 of every cycle, then Q6W(1st year), Q3M(2nd-3rd year), Q6M(4th year); until data cutoff 07Dec2014, up to 4 years
Title
Duration of Objective Response (DOR)
Description
DOR was defined as the time from the first documented response (CR or PR per RECIST v1.0), to the first documented protocol-defined disease progression (i.e., radiologically by RECIST, clinical, or symptomatic) or death, whichever occurred first. Participants who had neither progressed nor died at the time of data cut-off (07 December 2014), or participants who were withdrawn from study, or lost to follow-up without documented progression, were censored. RECIST responders: Participants achieving an overall response of CR (disappearance of all target lesions and non-target lesions) or PR (>=30% decrease in sum of the LD of the target lesions taking as a reference the baseline sum LD according to RECIST associated to non-progressive disease response for non-target lesions). Disease progression: Natural progression or deterioration of the malignancy under study (including new sites of metastasis).
Time Frame
Day 1, at end of Cycles 3 and 6, then every 6 cycles while receiving bevacizumab, and then at bevacizumab cessation, every 26 weeks after cessation of bevacizumab until disease progression or death until data cutoff 07 December 2014, up to 4 years
Title
Overall Survival (OS)
Description
OS was defined as the time from the date of the first administration of any study treatment to the date of death, regardless of the cause of death. Participants without the event of death were censored at the last date in the study, defined as the latest date of the following: the date of first administration of study treatment, date of last study treatment, date of last visit, or date last known to be alive. Kaplan-Meier estimation was used for OS.
Time Frame
First administration of any study treatment until death or data cutoff 07 December 2014, up to 4 years
Title
Biological Progression-free Interval
Description
Biological progression-free interval is defined as the interval from the date of the first administration of any study treatment to the date of the first documented serial elevation of the ovarian cancer mucin CA-125. More precisely, this is defined as the first documented increase in CA-125 levels as follows: (1) CA-125 greater than or equal to 2 times the upper level of normal (ULN) on 2 occasions at least 1 week apart (for participants with CA-125 within normal range pre-treatment) or (2) CA-125 greater than or equal to 2 times the ULN on 2 occasions at least 1 week apart (for participants with elevated CA-125 pre-treatment and initial normalization of CA-125 on-treatment) or (3) CA-125 greater than or equal to 2 times the nadir value, which is the lowest observed CA-125 value per participant on 2 occasions at least 1 week apart (for participants with elevated CA-125 pre-treatment which never normalized).
Time Frame
3 days prior to Day 1 of every cycle, then every 6 weeks during the first year, every 3 months in the second and third year, every 6 months in the fourth year of the study (until data cutoff 07 December 2014, up to 4 years)
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histologically confirmed epithelial ovarian carcinoma, fallopian tube carcinoma, primary peritoneal carcinoma or clear cell carcinoma or carcinosarcoma. Participants with recurrent ovarian cancer who have been previously treated with surgery alone for their early stage disease are eligible.
Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0, 1 or 2
Life expectancy greater than or equal to (>=3) months
Exclusion Criteria:
Participants with non-epithelial ovarian cancer, ovarian tumors with low malignant potential (i.e., borderline tumors), or synchronous primary endometrial carcinoma
Previous systemic therapy for ovarian cancer. Prior neo-adjuvant chemotherapy is allowed
Planned intraperitoneal cytotoxic chemotherapy
Radiotherapy within 28 days of Day 1, Cycle 1
Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to first dose of Avastin
History or evidence of National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Grade >=1 arterial thromboembolic event or Grade >=3 venous thromboembolic event within 6 months prior to enrollment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
City
Buenos Aires
ZIP/Postal Code
C1199ACI
Country
Argentina
City
Buenos Aires
ZIP/Postal Code
C1280AEB
Country
Argentina
City
Buenos Aires
ZIP/Postal Code
C1426ANZ
Country
Argentina
City
Rosario
ZIP/Postal Code
S2002KDS
Country
Argentina
City
Tucuman
ZIP/Postal Code
T4000IAK
Country
Argentina
City
Graz
ZIP/Postal Code
8020
Country
Austria
City
Graz
ZIP/Postal Code
8036
Country
Austria
City
Innsbruck
ZIP/Postal Code
6020
Country
Austria
City
Ried-innkreis
ZIP/Postal Code
4910
Country
Austria
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
City
Steyr
ZIP/Postal Code
4400
Country
Austria
City
Villach
ZIP/Postal Code
9500
Country
Austria
City
Wien
ZIP/Postal Code
1090
Country
Austria
City
Wien
ZIP/Postal Code
1130
Country
Austria
City
Salvador
State/Province
BA
ZIP/Postal Code
41950-610
Country
Brazil
City
Fortaleza
State/Province
CE
ZIP/Postal Code
60125-120
Country
Brazil
City
Goiania
State/Province
GO
ZIP/Postal Code
74605-070
Country
Brazil
City
Curitiba
State/Province
PR
ZIP/Postal Code
80530-010
Country
Brazil
City
Rio de Janeiro
State/Province
RJ
ZIP/Postal Code
20230-130
Country
Brazil
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90020-090
Country
Brazil
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90430-090
Country
Brazil
City
Piracicaba
State/Province
SP
ZIP/Postal Code
13419-155
Country
Brazil
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
01246-000
Country
Brazil
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
01308-050
Country
Brazil
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
01317-000
Country
Brazil
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
01509-010
Country
Brazil
City
Sofia
ZIP/Postal Code
1756
Country
Bulgaria
City
Varna
ZIP/Postal Code
9010
Country
Bulgaria
City
Veliko Tarnovo
ZIP/Postal Code
5000
Country
Bulgaria
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N2
Country
Canada
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
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
Quebec
ZIP/Postal Code
G1R 3S1
Country
Canada
City
Aalborg
ZIP/Postal Code
9000
Country
Denmark
City
Roskilde
ZIP/Postal Code
4000
Country
Denmark
City
Vejle
ZIP/Postal Code
7100
Country
Denmark
City
Cairo
ZIP/Postal Code
11555
Country
Egypt
City
Tanta
Country
Egypt
City
Tallinn
ZIP/Postal Code
11312
Country
Estonia
City
Tallinn
ZIP/Postal Code
13419
Country
Estonia
City
Tartu
ZIP/Postal Code
50406
Country
Estonia
City
Amiens
ZIP/Postal Code
80090
Country
France
City
Bordeaux
ZIP/Postal Code
33076
Country
France
City
Brest
ZIP/Postal Code
29200
Country
France
City
Caen
ZIP/Postal Code
14076
Country
France
City
Clermont Ferrand
ZIP/Postal Code
63011
Country
France
City
Grenoble
ZIP/Postal Code
38028
Country
France
City
Lille
ZIP/Postal Code
59020
Country
France
City
Lyon
ZIP/Postal Code
69373
Country
France
City
Marseille
ZIP/Postal Code
13273
Country
France
City
Mougins
ZIP/Postal Code
06250
Country
France
City
Paris
ZIP/Postal Code
75231
Country
France
City
Paris
ZIP/Postal Code
75571
Country
France
City
Paris
ZIP/Postal Code
75651
Country
France
City
Paris
ZIP/Postal Code
75674
Country
France
City
Paris
ZIP/Postal Code
75908
Country
France
City
Paris
ZIP/Postal Code
75970
Country
France
City
Reims CEDEX
ZIP/Postal Code
51056
Country
France
City
Strasbourg
ZIP/Postal Code
67065
Country
France
City
Toulouse
ZIP/Postal Code
31059
Country
France
City
Villejuif
ZIP/Postal Code
94805
Country
France
City
Athens
ZIP/Postal Code
115 28
Country
Greece
City
Athens
ZIP/Postal Code
11527
Country
Greece
City
Athens
ZIP/Postal Code
145 64
Country
Greece
City
Heraklion, Crete
ZIP/Postal Code
71110
Country
Greece
City
Larissa
ZIP/Postal Code
41 110
Country
Greece
City
Patras
ZIP/Postal Code
265 00
Country
Greece
City
Thessaloniki
ZIP/Postal Code
56429
Country
Greece
City
Hong Kong
ZIP/Postal Code
852
Country
Hong Kong
City
Hong Kong
Country
Hong Kong
City
Budapest
ZIP/Postal Code
1122
Country
Hungary
City
Budapest
ZIP/Postal Code
1125
Country
Hungary
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
City
Pecs
ZIP/Postal Code
7624
Country
Hungary
City
Szeged
ZIP/Postal Code
6720
Country
Hungary
City
Bangalore
ZIP/Postal Code
560017
Country
India
City
Bangalore
ZIP/Postal Code
560054
Country
India
City
Hyderabad
ZIP/Postal Code
650034
Country
India
City
Jaipur
ZIP/Postal Code
302013
Country
India
City
Kochi
ZIP/Postal Code
682304
Country
India
City
New Delhi
ZIP/Postal Code
110029
Country
India
City
Pune
ZIP/Postal Code
411004
Country
India
City
Dublin
ZIP/Postal Code
7
Country
Ireland
City
Afula
ZIP/Postal Code
18101
Country
Israel
City
Beer Sheva
ZIP/Postal Code
8410101
Country
Israel
City
Haifa
ZIP/Postal Code
31096
Country
Israel
City
Haifa
ZIP/Postal Code
34362
Country
Israel
City
Holon
ZIP/Postal Code
58100
Country
Israel
City
Jerusalem
ZIP/Postal Code
91120-01
Country
Israel
City
Jerusalem
ZIP/Postal Code
9372212
Country
Israel
City
Kfar Saba
ZIP/Postal Code
44281
Country
Israel
City
Petach Tikva
ZIP/Postal Code
49100
Country
Israel
City
Ramat Gan
ZIP/Postal Code
52621
Country
Israel
City
Rehovot
ZIP/Postal Code
7610001
Country
Israel
City
Tel Aviv
ZIP/Postal Code
64239-06
Country
Israel
City
Napoli
State/Province
Campania
ZIP/Postal Code
80131
Country
Italy
City
Bologna
State/Province
Emilia-Romagna
ZIP/Postal Code
40138
Country
Italy
City
Meldola
State/Province
Emilia-Romagna
ZIP/Postal Code
47014
Country
Italy
City
Roma
State/Province
Lazio
ZIP/Postal Code
00128
Country
Italy
City
Roma
State/Province
Lazio
ZIP/Postal Code
00157
Country
Italy
City
Genova
State/Province
Liguria
ZIP/Postal Code
16128
Country
Italy
City
Brescia
State/Province
Lombardia
ZIP/Postal Code
25123
Country
Italy
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20141
Country
Italy
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20162
Country
Italy
City
Monza
State/Province
Lombardia
ZIP/Postal Code
20052
Country
Italy
City
Saronno
State/Province
Lombardia
ZIP/Postal Code
21047
Country
Italy
City
Novara
State/Province
Piemonte
ZIP/Postal Code
28100
Country
Italy
City
Torino
State/Province
Piemonte
ZIP/Postal Code
10126
Country
Italy
City
Torino
State/Province
Piemonte
ZIP/Postal Code
10128
Country
Italy
City
Palermo
State/Province
Sicilia
ZIP/Postal Code
90146
Country
Italy
City
Firenze
State/Province
Toscana
ZIP/Postal Code
50139
Country
Italy
City
Pisa
State/Province
Toscana
ZIP/Postal Code
56126
Country
Italy
City
Perugia
State/Province
Umbria
ZIP/Postal Code
06123
Country
Italy
City
Terni
State/Province
Umbria
ZIP/Postal Code
05100
Country
Italy
City
Shuwaikh
ZIP/Postal Code
70653
Country
Kuwait
City
Daugavpils
ZIP/Postal Code
5417
Country
Latvia
City
Riga
ZIP/Postal Code
LV 1079
Country
Latvia
City
Riga
ZIP/Postal Code
LV-1002
Country
Latvia
City
Kaunas
ZIP/Postal Code
50009
Country
Lithuania
City
Klaipeda
ZIP/Postal Code
92288
Country
Lithuania
City
Vilnius
ZIP/Postal Code
08660
Country
Lithuania
City
Bitola
ZIP/Postal Code
7000
Country
Macedonia, The Former Yugoslav Republic of
City
Skopje
ZIP/Postal Code
1000
Country
Macedonia, The Former Yugoslav Republic of
City
Distrito Federal
ZIP/Postal Code
14080
Country
Mexico
City
Oaxaca
ZIP/Postal Code
68000
Country
Mexico
City
Toluca
ZIP/Postal Code
50180
Country
Mexico
City
Alkmaar
ZIP/Postal Code
1815 JD
Country
Netherlands
City
Amsterdam
ZIP/Postal Code
1091 AC
Country
Netherlands
City
Apeldoorn
ZIP/Postal Code
7334 DZ
Country
Netherlands
City
Blaricum
ZIP/Postal Code
1261 AN
Country
Netherlands
City
Breda
ZIP/Postal Code
4819 EV
Country
Netherlands
City
Capelle a/d IJssel
ZIP/Postal Code
NL 2900 AR
Country
Netherlands
City
Den Haag
ZIP/Postal Code
2512 VA
Country
Netherlands
City
Den Haag
ZIP/Postal Code
2545 CH
Country
Netherlands
City
Deventer
ZIP/Postal Code
7416 SE
Country
Netherlands
City
Dordrecht
ZIP/Postal Code
3318 AT
Country
Netherlands
City
Eindhoven
ZIP/Postal Code
5623 EJ
Country
Netherlands
City
Leidschendam
ZIP/Postal Code
2262 BA
Country
Netherlands
City
Rotterdam
ZIP/Postal Code
3045 PM
Country
Netherlands
City
Sittard-Geleen
ZIP/Postal Code
6162 BG
Country
Netherlands
City
Utrecht
ZIP/Postal Code
3582 KE
Country
Netherlands
City
Bydgoszcz
ZIP/Postal Code
85-796
Country
Poland
City
Warszawa
ZIP/Postal Code
03-242
Country
Poland
City
Porto
ZIP/Postal Code
4200-072
Country
Portugal
City
Bucuresti
ZIP/Postal Code
022328
Country
Romania
City
Cluj Napoca
ZIP/Postal Code
400015
Country
Romania
City
Iasi
ZIP/Postal Code
700106
Country
Romania
City
Barnaul
ZIP/Postal Code
656049
Country
Russian Federation
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
City
Obninsk, Kaluzhskaya Region
ZIP/Postal Code
249034
Country
Russian Federation
City
Saint-Petersburg
ZIP/Postal Code
197022
Country
Russian Federation
City
Stavropol
ZIP/Postal Code
355045
Country
Russian Federation
City
UFA
ZIP/Postal Code
450054
Country
Russian Federation
City
Dammam
ZIP/Postal Code
31444
Country
Saudi Arabia
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
City
Nis
ZIP/Postal Code
18000
Country
Serbia
City
Bratislava
ZIP/Postal Code
833 10
Country
Slovakia
City
Kosice
ZIP/Postal Code
04001
Country
Slovakia
City
Ljubljana
ZIP/Postal Code
1000
Country
Slovenia
City
Maribor
ZIP/Postal Code
2000
Country
Slovenia
City
Durban
ZIP/Postal Code
4058
Country
South Africa
City
Johannesburg
ZIP/Postal Code
2193
Country
South Africa
City
Sandton
ZIP/Postal Code
2196
Country
South Africa
City
Elda
State/Province
Alicante
ZIP/Postal Code
03600
Country
Spain
City
Oviedo
State/Province
Asturias
ZIP/Postal Code
33011
Country
Spain
City
Llerena (Badajoz)
State/Province
Badajoz
ZIP/Postal Code
06900
Country
Spain
City
Manresa
State/Province
Barcelona
ZIP/Postal Code
08243
Country
Spain
City
Cádiz
State/Province
Cadiz
ZIP/Postal Code
11009
Country
Spain
City
Jerez de La Frontera
State/Province
Cadiz
ZIP/Postal Code
11407
Country
Spain
City
San Sebastian de Los Reyes
State/Province
Guipuzcoa
ZIP/Postal Code
28702
Country
Spain
City
San Sebastian
State/Province
Guipuzcoa
ZIP/Postal Code
20080
Country
Spain
City
Palma De Mallorca
State/Province
Islas Baleares
ZIP/Postal Code
07014
Country
Spain
City
Palma de Mallorca
State/Province
Islas Baleares
ZIP/Postal Code
07198
Country
Spain
City
Santiago de Compostela
State/Province
La Coruña
ZIP/Postal Code
15706
Country
Spain
City
Las Palmas de Gran Canaria
State/Province
Las Palmas
ZIP/Postal Code
35020
Country
Spain
City
Leganes
State/Province
Madrid
ZIP/Postal Code
28911
Country
Spain
City
Reus
State/Province
Tarragona
ZIP/Postal Code
43204
Country
Spain
City
La Laguna
State/Province
Tenerife
ZIP/Postal Code
38320
Country
Spain
City
Santa Cruz de Tenerife
State/Province
Tenerife
ZIP/Postal Code
38010
Country
Spain
City
San Juan
State/Province
Valencia
ZIP/Postal Code
03550
Country
Spain
City
Barakaldo
State/Province
Vizcaya
ZIP/Postal Code
48903
Country
Spain
City
Bilbao
State/Province
Vizcaya
ZIP/Postal Code
48013
Country
Spain
City
Albacete
ZIP/Postal Code
02006
Country
Spain
City
Alicante
ZIP/Postal Code
3010
Country
Spain
City
Badajoz
ZIP/Postal Code
06080
Country
Spain
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
City
Barcelona
ZIP/Postal Code
08017
Country
Spain
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
City
Barcelona
ZIP/Postal Code
08906
Country
Spain
City
Burgos
ZIP/Postal Code
09006
Country
Spain
City
Caceres
ZIP/Postal Code
10003
Country
Spain
City
Castellon
ZIP/Postal Code
12002
Country
Spain
City
Ciudad Real
ZIP/Postal Code
13005
Country
Spain
City
Cordoba
ZIP/Postal Code
14004
Country
Spain
City
Girona
ZIP/Postal Code
17007
Country
Spain
City
Granada
ZIP/Postal Code
18014
Country
Spain
City
Guadalajara
ZIP/Postal Code
19002
Country
Spain
City
Jaen
ZIP/Postal Code
23007
Country
Spain
City
La Coruña
ZIP/Postal Code
15006
Country
Spain
City
Lugo
ZIP/Postal Code
27003
Country
Spain
City
Madrid
ZIP/Postal Code
28002
Country
Spain
City
Madrid
ZIP/Postal Code
28007
Country
Spain
City
Madrid
ZIP/Postal Code
28033
Country
Spain
City
Madrid
ZIP/Postal Code
28040
Country
Spain
City
Madrid
ZIP/Postal Code
28041
Country
Spain
City
Madrid
ZIP/Postal Code
28050
Country
Spain
City
Madrid
ZIP/Postal Code
28222
Country
Spain
City
Malaga
ZIP/Postal Code
29010
Country
Spain
City
Malaga
ZIP/Postal Code
29011
Country
Spain
City
Navarra
ZIP/Postal Code
31008
Country
Spain
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
City
Segovia
ZIP/Postal Code
40002
Country
Spain
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
City
Sevilla
ZIP/Postal Code
41014
Country
Spain
City
Toledo
ZIP/Postal Code
45004
Country
Spain
City
Valencia
ZIP/Postal Code
46009
Country
Spain
City
Valencia
ZIP/Postal Code
46015
Country
Spain
City
Valencia
ZIP/Postal Code
46017
Country
Spain
City
Valencia
ZIP/Postal Code
46026
Country
Spain
City
Valladolid
ZIP/Postal Code
47010
Country
Spain
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
City
Eskilstuna
ZIP/Postal Code
63188
Country
Sweden
City
Falun
ZIP/Postal Code
79182
Country
Sweden
City
Karlstad
ZIP/Postal Code
65185
Country
Sweden
City
Umeå
Country
Sweden
City
Uppsala
ZIP/Postal Code
75185
Country
Sweden
City
Örebro
ZIP/Postal Code
701 85
Country
Sweden
City
Aarau
ZIP/Postal Code
5001
Country
Switzerland
City
Baden
ZIP/Postal Code
5405
Country
Switzerland
City
Bellinzona
ZIP/Postal Code
6500
Country
Switzerland
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
City
Genève 14
ZIP/Postal Code
1211
Country
Switzerland
City
Zürich
ZIP/Postal Code
8091
Country
Switzerland
City
Taipei City
ZIP/Postal Code
110
Country
Taiwan
City
Taipei City
ZIP/Postal Code
112
Country
Taiwan
City
Taoyuan Hsien
ZIP/Postal Code
333
Country
Taiwan
City
Ankara
ZIP/Postal Code
06230
Country
Turkey
City
Ankara
ZIP/Postal Code
06500
Country
Turkey
City
Diyarbakir
ZIP/Postal Code
10000
Country
Turkey
City
Istanbul
ZIP/Postal Code
34390
Country
Turkey
City
Montevideo
ZIP/Postal Code
11600
Country
Uruguay
12. IPD Sharing Statement
Citations:
PubMed Identifier
27749456
Citation
Oza AM, Selle F, Davidenko I, Korach J, Mendiola C, Pautier P, Chmielowska E, Bamias A, DeCensi A, Zvirbule Z, Gonzalez-Martin A, Hegg R, Joly F, Zamagni C, Gadducci A, Martin N, Robb S, Colombo N. Efficacy and Safety of Bevacizumab-Containing Therapy in Newly Diagnosed Ovarian Cancer: ROSiA Single-Arm Phase 3B Study. Int J Gynecol Cancer. 2017 Jan;27(1):50-58. doi: 10.1097/IGC.0000000000000836.
Results Reference
derived
Learn more about this trial
A Study of the Addition of Avastin (Bevacizumab) to Carboplatin and Paclitaxel Therapy in Patients With Ovarian Cancer
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