Clinical trial NCT01239732: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Ovarian Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2010-11-11
Enrollment: 1021
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Percentage of Participants With at Least One Adverse Event (AE)
timeFrame: Day 1 up to 30 days after last dose of study treatment (until data cutoff 07 December 2014, up to 4 years)
Secondary outcomes:
measure: Progression-Free Survival (PFS)
timeFrame: 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
measure: Percentage of Participants Achieving Best Overall Response of Complete Response (CR) or Partial Response (PR) According to RECIST Version 1.0
timeFrame: 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
measure: Percentage of Participants Achieving an Overall Response by 50% Carcinoma Antigen 125 (CA-125) Response Criteria
timeFrame: 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)
measure: Percentage of Participants Achieving an Overall Response by RECIST Version 1.0 and/or 50% CA-125 Response Criteria
timeFrame: 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
measure: Duration of Objective Response (DOR)
timeFrame: 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
measure: Overall Survival (OS)
timeFrame: First administration of any study treatment until death or data cutoff 07 December 2014, up to 4 years
measure: Biological Progression-free Interval
timeFrame: 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)
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
city: Buenos Aires
country: Argentina
city: Buenos Aires
country: Argentina
city: Rosario
country: Argentina
city: Tucuman
country: Argentina
city: Graz
country: Austria
city: Graz
country: Austria
city: Innsbruck
country: Austria
city: Ried-innkreis
country: Austria
city: Salzburg
country: Austria
city: Steyr
country: Austria
city: Villach
country: Austria
city: Wien
country: Austria
city: Wien
country: Austria
city: Salvador
country: Brazil
state: BA
city: Fortaleza
country: Brazil
state: CE
city: Goiania
country: Brazil
state: GO
city: Curitiba
country: Brazil
state: PR
city: Rio de Janeiro
country: Brazil
state: RJ
city: Porto Alegre
country: Brazil
state: RS
city: Porto Alegre
country: Brazil
state: RS
city: Piracicaba
country: Brazil
state: SP
city: Sao Paulo
country: Brazil
state: SP
city: Sao Paulo
country: Brazil
state: SP
city: Sao Paulo
country: Brazil
state: SP
city: Sao Paulo
country: Brazil
state: SP
city: Sofia
country: Bulgaria
city: Varna
country: Bulgaria
city: Veliko Tarnovo
country: Bulgaria
city: Calgary
country: Canada
state: Alberta
city: Ottawa
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Montreal
country: Canada
state: Quebec
city: Quebec
country: Canada
city: Aalborg
country: Denmark
city: Roskilde
country: Denmark
city: Vejle
country: Denmark
city: Cairo
country: Egypt
city: Tanta
country: Egypt
city: Tallinn
country: Estonia
city: Tallinn
country: Estonia
city: Tartu
country: Estonia
city: Amiens
country: France
city: Bordeaux
country: France
city: Brest
country: France
city: Caen
country: France
city: Clermont Ferrand
country: France
city: Grenoble
country: France
city: Lille
country: France
city: Lyon
country: France
city: Marseille
country: France
city: Mougins
country: France
city: Paris
country: France
city: Paris
country: France
city: Paris
country: France
city: Paris
country: France
city: Paris
country: France
city: Paris
country: France
city: Reims CEDEX
country: France
city: Strasbourg
country: France
city: Toulouse
country: France
city: Villejuif
country: France
city: Athens
country: Greece
city: Athens
country: Greece
city: Athens
country: Greece
city: Heraklion, Crete
country: Greece
city: Larissa
country: Greece
city: Patras
country: Greece
city: Thessaloniki
country: Greece
city: Hong Kong
country: Hong Kong
city: Hong Kong
country: Hong Kong
city: Budapest
country: Hungary
city: Budapest
country: Hungary
city: Debrecen
country: Hungary
city: Pecs
country: Hungary
city: Szeged
country: Hungary
city: Bangalore
country: India
city: Bangalore
country: India
city: Hyderabad
country: India
city: Jaipur
country: India
city: Kochi
country: India
city: New Delhi
country: India
city: Pune
country: India
city: Dublin
country: Ireland
city: Afula
country: Israel
city: Beer Sheva
country: Israel
city: Haifa
country: Israel
city: Haifa
country: Israel
city: Holon
country: Israel
city: Jerusalem
country: Israel
city: Jerusalem
country: Israel
city: Kfar Saba
country: Israel
city: Petach Tikva
country: Israel
city: Ramat Gan
country: Israel
city: Rehovot
country: Israel
city: Tel Aviv
country: Israel
city: Napoli
country: Italy
state: Campania
city: Bologna
country: Italy
state: Emilia-Romagna
city: Meldola
country: Italy
state: Emilia-Romagna
city: Roma
country: Italy
state: Lazio
city: Roma
country: Italy
state: Lazio
city: Genova
country: Italy
state: Liguria
city: Brescia
country: Italy
state: Lombardia
city: Milano
country: Italy
state: Lombardia
city: Milano
country: Italy
state: Lombardia
city: Monza
country: Italy
state: Lombardia
city: Saronno
country: Italy
state: Lombardia
city: Novara
country: Italy
state: Piemonte
city: Torino
country: Italy
state: Piemonte
city: Torino
country: Italy
state: Piemonte
city: Palermo
country: Italy
state: Sicilia
city: Firenze
country: Italy
state: Toscana
city: Pisa
country: Italy
state: Toscana
city: Perugia
country: Italy
state: Umbria
city: Terni
country: Italy
state: Umbria
city: Shuwaikh
country: Kuwait
city: Daugavpils
country: Latvia
city: Riga
country: Latvia
city: Riga
country: Latvia
city: Kaunas
country: Lithuania
city: Klaipeda
country: Lithuania
city: Vilnius
country: Lithuania
city: Bitola
country: Macedonia, The Former Yugoslav Republic of
city: Skopje
country: Macedonia, The Former Yugoslav Republic of
city: Distrito Federal
country: Mexico
city: Oaxaca
country: Mexico
city: Toluca
country: Mexico
city: Alkmaar
country: Netherlands
city: Amsterdam
country: Netherlands
city: Apeldoorn
country: Netherlands
city: Blaricum
country: Netherlands
city: Breda
country: Netherlands
city: Capelle a/d IJssel
country: Netherlands
city: Den Haag
country: Netherlands
city: Den Haag
country: Netherlands
city: Deventer
country: Netherlands
city: Dordrecht
country: Netherlands
city: Eindhoven
country: Netherlands
city: Leidschendam
country: Netherlands
city: Rotterdam
country: Netherlands
city: Sittard-Geleen
country: Netherlands
city: Utrecht
country: Netherlands
city: Bydgoszcz
country: Poland
city: Warszawa
country: Poland
city: Porto
country: Portugal
city: Bucuresti
country: Romania
city: Cluj Napoca
country: Romania
city: Iasi
country: Romania
city: Barnaul
country: Russian Federation
city: Moscow
country: Russian Federation
city: Obninsk, Kaluzhskaya Region
country: Russian Federation
city: Saint-Petersburg
country: Russian Federation
city: Stavropol
country: Russian Federation
city: UFA
country: Russian Federation
city: Dammam
country: Saudi Arabia
city: Belgrade
country: Serbia
city: Nis
country: Serbia
city: Bratislava
country: Slovakia
city: Kosice
country: Slovakia
city: Ljubljana
country: Slovenia
city: Maribor
country: Slovenia
city: Durban
country: South Africa
city: Johannesburg
country: South Africa
city: Sandton
country: South Africa
city: Elda
country: Spain
state: Alicante
city: Oviedo
country: Spain
state: Asturias
city: Llerena (Badajoz)
country: Spain
state: Badajoz
city: Manresa
country: Spain
state: Barcelona
city: Cádiz
country: Spain
state: Cadiz
city: Jerez de La Frontera
country: Spain
state: Cadiz
city: San Sebastian de Los Reyes
country: Spain
state: Guipuzcoa
city: San Sebastian
country: Spain
state: Guipuzcoa
city: Palma De Mallorca
country: Spain
state: Islas Baleares
city: Palma de Mallorca
country: Spain
state: Islas Baleares
city: Santiago de Compostela
country: Spain
state: La Coruña
city: Las Palmas de Gran Canaria
country: Spain
state: Las Palmas
city: Leganes
country: Spain
state: Madrid
city: Reus
country: Spain
state: Tarragona
city: La Laguna
country: Spain
state: Tenerife
city: Santa Cruz de Tenerife
country: Spain
state: Tenerife
city: San Juan
country: Spain
state: Valencia
city: Barakaldo
country: Spain
state: Vizcaya
city: Bilbao
country: Spain
state: Vizcaya
city: Albacete
country: Spain
city: Alicante
country: Spain
city: Badajoz
country: Spain
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Burgos
country: Spain
city: Caceres
country: Spain
city: Castellon
country: Spain
city: Ciudad Real
country: Spain
city: Cordoba
country: Spain
city: Girona
country: Spain
city: Granada
country: Spain
city: Guadalajara
country: Spain
city: Jaen
country: Spain
city: La Coruña
country: Spain
city: Lugo
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Malaga
country: Spain
city: Malaga
country: Spain
city: Navarra
country: Spain
city: Salamanca
country: Spain
city: Segovia
country: Spain
city: Sevilla
country: Spain
city: Sevilla
country: Spain
city: Toledo
country: Spain
city: Valencia
country: Spain
city: Valencia
country: Spain
city: Valencia
country: Spain
city: Valencia
country: Spain
city: Valladolid
country: Spain
city: Zaragoza
country: Spain
city: Eskilstuna
country: Sweden
city: Falun
country: Sweden
city: Karlstad
country: Sweden
city: Umeå
country: Sweden
city: Uppsala
country: Sweden
city: Örebro
country: Sweden
city: Aarau
country: Switzerland
city: Baden
country: Switzerland
city: Bellinzona
country: Switzerland
city: Bern
country: Switzerland
city: Genève 14
country: Switzerland
city: Zürich
country: Switzerland
city: Taipei City
country: Taiwan
city: Taipei City
country: Taiwan
city: Taoyuan Hsien
country: Taiwan
city: Ankara
country: Turkey
city: Ankara
country: Turkey
city: Diyarbakir
country: Turkey
city: Istanbul
country: Turkey
city: Montevideo
country: Uruguay
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
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.