A Study of the Addition of Avastin (Bevacizumab) to Carboplatin and Paclitaxel Therapy in Patients With Ovarian Cancer

NCT ID: NCT01239732

Last Updated: 2016-06-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1021 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-12-31
• Study Completion Date: 2015-03-31

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.

Conditions

Ovarian Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Bevacizumab + Paclitaxel + Carboplatin

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).

Group Type: EXPERIMENTAL

Paclitaxel

Intervention Type: DRUG

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

Bevacizumab

Intervention Type: DRUG

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

Carboplatin

Intervention Type: DRUG

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

Interventions

Paclitaxel

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

Bevacizumab

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

Carboplatin

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

Intervention Type: DRUG

Other Intervention Names

Avastin

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

Buenos Aires, , Argentina

Buenos Aires, , Argentina

Buenos Aires, , Argentina

Rosario, , Argentina

San Miguel de Tucumán, , Argentina

Graz, , Austria

Graz, , Austria

Innsbruck, , Austria

Ried-innkreis, , Austria

Salzburg, , Austria

Steyr, , Austria

Vienna, , Austria

Vienna, , Austria

Villach, , Austria

Fortaleza, Ceará, Brazil

Salvador, Estado de Bahia, Brazil

Goiânia, Goiás, Brazil

Curitiba, Paraná, Brazil

Rio de Janeiro, Rio de Janeiro, Brazil

Porto Alegre, Rio Grande do Sul, Brazil

Porto Alegre, Rio Grande do Sul, Brazil

Piracicaba, São Paulo, Brazil

São Paulo, São Paulo, Brazil

São Paulo, São Paulo, Brazil

São Paulo, São Paulo, Brazil

São Paulo, São Paulo, Brazil

Sofia, , Bulgaria

Varna, , Bulgaria

Veliko Tarnovo, , Bulgaria

Calgary, Alberta, Canada

Ottawa, Ontario, Canada

Toronto, Ontario, Canada

Montreal, Quebec, Canada

Québec, Quebec, Canada

Aalborg, , Denmark

Roskilde, , Denmark

Vejle, , Denmark

Cairo, , Egypt

Tanta, , Egypt

Tallinn, , Estonia

Tallinn, , Estonia

Tartu, , Estonia

Amiens, , France

Bordeaux, , France

Brest, , France

Caen, , France

Clermont-Ferrand, , France

Grenoble, , France

Lille, , France

Lyon, , France

Marseille, , France

Mougins, , France

Paris, , France

Paris, , France

Paris, , France

Paris, , France

Paris, , France

Paris, , France

Reims, , France

Strasbourg, , France

Toulouse, , France

Villejuif, , France

Athens, , Greece

Athens, , Greece

Athens, , Greece

Heraklion, Crete, , Greece

Larissa, , Greece

Pátrai, , Greece

Thessaloniki, , Greece

Hong Kong, , Hong Kong

Hong Kong, , Hong Kong

Budapest, , Hungary

Budapest, , Hungary

Debrecen, , Hungary

Pécs, , Hungary

Szeged, , Hungary

Bangalore, , India

Bangalore, , India

Hyderabad, , India

Jaipur, , India

Kochi, , India

New Delhi, , India

Pune, , India

Dublin, , Ireland

Afula, , Israel

Beersheba, , Israel

Haifa, , Israel

Haifa, , Israel

Holon, , Israel

Jerusalem, , Israel

Jerusalem, , Israel

Kfar Saba, , Israel

Petah Tikva, , Israel

Ramat Gan, , Israel

Rehovot, , Israel

Tel Aviv, , Israel

Napoli, Campania, Italy

Bologna, Emilia-Romagna, Italy

Meldola, Emilia-Romagna, Italy

Rome, Lazio, Italy

Rome, Lazio, Italy

Genoa, Liguria, Italy

Brescia, Lombardy, Italy

Milan, Lombardy, Italy

Milan, Lombardy, Italy

Monza, Lombardy, Italy

Saronno, Lombardy, Italy

Novara, Piedmont, Italy

Turin, Piedmont, Italy

Turin, Piedmont, Italy

Palermo, Sicily, Italy

Florence, Tuscany, Italy

Pisa, Tuscany, Italy

Perugia, Umbria, Italy

Terni, Umbria, Italy

Ash Shuwaykh, , Kuwait

Daugavpils, , Latvia

Riga, , Latvia

Riga, , Latvia

Kaunas, , Lithuania

Klaipėda, , Lithuania

Vilnius, , Lithuania

Distrito Federal, , Mexico

Oaxaca City, , Mexico

Toluca, , Mexico

Alkmaar, , Netherlands

Amsterdam, , Netherlands

Apeldoorn, , Netherlands

Blaricum, , Netherlands

Breda, , Netherlands

Capelle aan den IJssel, , Netherlands

Deventer, , Netherlands

Dordrecht, , Netherlands

Eindhoven, , Netherlands

Leidschendam, , Netherlands

Rotterdam, , Netherlands

Sittard-Geleen, , Netherlands

The Hague, , Netherlands

The Hague, , Netherlands

Utrecht, , Netherlands

Bitola, , North Macedonia

Skopje, , North Macedonia

Bydgoszcz, , Poland

Warsaw, , Poland

Porto, , Portugal

Bucharest, , Romania

Cluj-Napoca, , Romania

Iași, , Romania

Barnaul, , Russia

Moscow, , Russia

Obninsk, Kaluzhskaya Region, , Russia

Saint Petersburg, , Russia

Stavropol, , Russia

Ufa, , Russia

Dammam, , Saudi Arabia

Belgrade, , Serbia

Niš, , Serbia

Bratislava, , Slovakia

Košice, , Slovakia

Ljubljana, , Slovenia

Maribor, , Slovenia

Durban, , South Africa

Johannesburg, , South Africa

Sandton, , South Africa

Albacete, Albacete, Spain

Alicante, Alicante, Spain

Elda, Alicante, Spain

Badajoz, Badajoz, Spain

Llerena (Badajoz), Badajoz, Spain

Palma de Mallorca, Balearic Islands, Spain

Palma de Mallorca, Balearic Islands, Spain

Barcelona, Barcelona, Spain

Barcelona, Barcelona, Spain

Barcelona, Barcelona, Spain

Barcelona, Barcelona, Spain

Manresa, Barcelona, Spain

Burgos, Burgos, Spain

Cáceres, Caceres, Spain

Cadiz, Cadiz, Spain

Jerez de la Frontera, Cadiz, Spain

Castellon, Castellon, Spain

Ciudad Real, Ciudad Real, Spain

Córdoba, Cordoba, Spain

Girona, Girona, Spain

Granada, Granada, Spain

Guadalajara, Guadalajara, Spain

Donostia / San Sebastian, Guipuzcoa, Spain

San Sebastián de los Reyes, Guipuzcoa, Spain

Jaén, Jaen, Spain

A Coruña, La Coruña, Spain

Santiago de Compostela, La Coruña, Spain

Las Palmas de Gran Canaria, Las Palmas, Spain

Lugo, Lugo, Spain

Leganés, Madrid, Spain

Madrid, Madrid, Spain

Madrid, Madrid, Spain

Madrid, Madrid, Spain

Madrid, Madrid, Spain

Madrid, Madrid, Spain

Madrid, Madrid, Spain

Madrid, Madrid, Spain

Málaga, Malaga, Spain

Málaga, Malaga, Spain

Navarra, Navarre, Spain

Oviedo, Principality of Asturias, Spain

Salamanca, Salamanca, Spain

Segovia, Segovia, Spain

Seville, Sevilla, Spain

Seville, Sevilla, Spain

Reus, Tarragona, Spain

San Cristóbal de La Laguna, Tenerife, Spain

Santa Cruz de Tenerife, Tenerife, Spain

Toledo, Toledo, Spain

San Juan, Valencia, Spain

Valencia, Valencia, Spain

Valencia, Valencia, Spain

Valencia, Valencia, Spain

Valencia, Valencia, Spain

Valladolid, Valladolid, Spain

Barakaldo, Vizcaya, Spain

Bilbao, Vizcaya, Spain

Zaragoza, Zaragoza, Spain

Eskilstuna, , Sweden

Falun, , Sweden

Karlstad, , Sweden

Örebro, , Sweden

Umeå, , Sweden

Uppsala, , Sweden

Aarau, , Switzerland

Baden, , Switzerland

Bellinzona, , Switzerland

Bern, , Switzerland

Geneva, , Switzerland

Zurich, , Switzerland

Taipei, , Taiwan

Taipei, , Taiwan

Taoyuan Hsien, , Taiwan

Ankara, , Turkey (Türkiye)

Ankara, , Turkey (Türkiye)

Diyarbakır, , Turkey (Türkiye)

Istanbul, , Turkey (Türkiye)

Montevideo, , Uruguay

Countries

Argentina; Austria; Brazil; Bulgaria; Canada; Denmark; Egypt; Estonia; France; Greece; Hong Kong; Hungary; India; Ireland; Israel; Italy; Kuwait; Latvia; Lithuania; Mexico; Netherlands; North Macedonia; Poland; Portugal; Romania; Russia; Saudi Arabia; Serbia; Slovakia; Slovenia; South Africa; Spain; Sweden; Switzerland; Taiwan; Turkey (Türkiye); Uruguay

References

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.

Reference Type: DERIVED

PMID: 27749456 (View on PubMed)

Other Identifiers

2010-019525-34

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

MO22923

Identifier Type: -

Identifier Source: org_study_id