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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01239732
First received: November 10, 2010
Last updated: August 19, 2014
Last verified: August 2014
  Purpose

This open-label, non-comparative, multi-center study will assess the safety prof ile and efficacy of Avastin (bevacizumab) when added to carboplatin and paclitax el therapy in patients with epithelial ovarian cancer, fallopian tube carcinoma or primary peritoneal carcinoma. Patients will receive 15 mg/kg Avastin intraven ously on Day 1 of every cycle for up to 36 cycles of 3 weeks each, carboplatin ( AUC 5-6 mg/ml/min) on Day 1 every 3 weeks for a maximum of 8 cycles and paclitax el 175 mg/m2 on Day 1 every 3 weeks or 80 mg/m2 every week for a maximum of 8 cy cles. The anticipated time on study drug will be 108 weeks or until disease prog ression or unacceptable toxicity.


Condition Intervention Phase
Ovarian Cancer
Drug: bevacizumab [Avastin]
Drug: carboplatin
Drug: Paclitaxel
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Safety profile (incidence of adverse events) of Avastin when added to carboplatin and paclitaxel chemotherapy [ Time Frame: 108 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression-free survival according to Response evaluation criteria in solid tumors (RECIST) [ Time Frame: 108 weeks ] [ Designated as safety issue: No ]
  • Overall response rate according to Response evaluation criteria in solid tumors (RECIST) [ Time Frame: 108 weeks ] [ Designated as safety issue: No ]
  • Overall response rate according to Cancer antigen 125 criteria [ Time Frame: 108 weeks ] [ Designated as safety issue: No ]
  • Duration of response according to Response evaluation criteria in solid tumors (RECIST) [ Time Frame: 108 weeks ] [ Designated as safety issue: No ]
  • Overall survival according to Response evaluation criteria in solid tumors (RECIST) [ Time Frame: 108 weeks ] [ Designated as safety issue: No ]
  • Biological progression-free survival according to Response evaluation criteria in solid tumors (RECIST) [ Time Frame: 108 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 1000
Study Start Date: December 2010
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single Arm Drug: bevacizumab [Avastin]
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
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
Drug: Paclitaxel
175 mg/m2 on Day 1 every 3 weeks or at a dose of 80 mg/m2 every week for a minimum of 4 cycles and not more than 8 cycles or until disease progression or unacceptable toxicity, whichever occurs first

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Female patients, >/=18 years of age
  • Histologically confirmed epithelial ovarian carcinoma, fallopian tube carcinoma, primary peritoneal carcinoma or clear cell carcinoma or carcinosarcoma. Patients 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 >/=3 months

Exclusion Criteria:

  • Patients 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 NCI CTAE Grade >/=1 arterial thromboembolic event or Grade >/=3 venous thromboembolic event within 6 months prior to enrolment
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01239732

Contacts
Contact: Reference Study ID Number: MO22923 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com

  Hide Study Locations
Locations
Argentina
Active, not recruiting
Buenos Aires, Argentina, C1199ACI
Completed
Buenos Aires, Argentina, C1426ANZ
Active, not recruiting
Buenos Aires, Argentina, C1280AEB
Active, not recruiting
Rosario, Argentina, S2002KDS
Terminated
Tucuman, Argentina, T4000IAK
Austria
Active, not recruiting
Graz, Austria, 8036
Active, not recruiting
Graz, Austria, 8020
Active, not recruiting
Innsbruck, Austria, 6020
Completed
Ried-innkreis, Austria, 4910
Active, not recruiting
Salzburg, Austria, 5020
Completed
Salzburg, Austria, 5020
Active, not recruiting
Steyr, Austria, 4400
Active, not recruiting
Villach, Austria, 9500
Active, not recruiting
Wien, Austria, 1130
Completed
Wien, Austria, 1090
Brazil
Completed
Salvador, BA, Brazil, 41950-610
Completed
Fortaleza, CE, Brazil, 60125-120
Active, not recruiting
Goiania, GO, Brazil, 74605-070
Active, not recruiting
Curitiba, PR, Brazil, 80530-010
Active, not recruiting
Rio de Janeiro, RJ, Brazil, 20230-130
Completed
Porto Alegre, RS, Brazil, 90020-090
Active, not recruiting
Porto Alegre, RS, Brazil, 90430-090
Completed
Piracicaba, SP, Brazil, 13419-155
Active, not recruiting
Sao Paulo, SP, Brazil, 01317-000
Active, not recruiting
Sao Paulo, SP, Brazil, 01246-000
Active, not recruiting
Sao Paulo, SP, Brazil, 01509-010
Completed
Sao Paulo, SP, Brazil, 01308-050
Bulgaria
Active, not recruiting
Sofia, Bulgaria, 1756
Active, not recruiting
Varna, Bulgaria, 9010
Active, not recruiting
Veliko Tarnovo, Bulgaria, 5000
Canada, Alberta
Active, not recruiting
Calgary, Alberta, Canada, T2N 4N2
Canada, Ontario
Completed
Ottawa, Ontario, Canada, K1H 8L6
Active, not recruiting
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
Active, not recruiting
Montreal, Quebec, Canada, H2L 4M1
Canada
Active, not recruiting
Quebec, Canada, G1R 2J6
Denmark
Completed
Aalborg, Denmark, 9000
Active, not recruiting
Roskilde, Denmark, 4000
Completed
Vejle, Denmark, 7100
Egypt
Completed
Cairo, Egypt, 11555
Completed
Tanta, Egypt
Estonia
Active, not recruiting
Tallinn, Estonia, 13419
Active, not recruiting
Tallinn, Estonia, 11312
Active, not recruiting
Tartu, Estonia, 50406
France
Active, not recruiting
Amiens, France, 80090
Active, not recruiting
Bordeaux, France, 33076
Active, not recruiting
Brest, France, 29200
Active, not recruiting
Caen, France, 14076
Active, not recruiting
Clermont Ferrand, France, 63011
Completed
Grenoble, France, 38028
Active, not recruiting
Lille, France, 59020
Active, not recruiting
Lyon, France, 69373
Active, not recruiting
Marseille, France, 13273
Active, not recruiting
Mougins, France, 06250
Completed
Paris, France, 75908
Active, not recruiting
Paris, France, 75231
Completed
Paris, France, 75571
Active, not recruiting
Paris, France, 75970
Active, not recruiting
Paris, France, 75651
Active, not recruiting
Paris, France, 75674
Active, not recruiting
Reims CEDEX, France, 51056
Active, not recruiting
Strasbourg, France, 67065
Active, not recruiting
Toulouse, France, 31059
Active, not recruiting
Villejuif, France, 94805
Greece
Completed
Athens, Greece, 14564
Active, not recruiting
Athens, Greece, 115 28
Completed
Athens, Greece, 11527
Active, not recruiting
Heraklion, Greece, 711 10
Completed
Larissa, Greece, 41 110
Active, not recruiting
Patras, Greece, 265 00
Active, not recruiting
Thessaloniki, Greece, 56429
Hong Kong
Active, not recruiting
Hong Kong, Hong Kong
Hungary
Active, not recruiting
Budapest, Hungary, 1125
Active, not recruiting
Budapest, Hungary, 1122
Active, not recruiting
Debrecen, Hungary, 4032
Active, not recruiting
Pecs, Hungary, 7624
Active, not recruiting
Szeged, Hungary, 6701
India
Active, not recruiting
Bangalore, India, 560017
Active, not recruiting
Bangalore, India, 560054
Active, not recruiting
Hyderabad, India, 650034
Active, not recruiting
Jaipur, India, 302013
Active, not recruiting
Kochi, India, 682304
Completed
New Delhi, India, 110029
Completed
Pune, India, 411004
Ireland
Completed
Dublin, Ireland, 7
Israel
Completed
Afula, Israel, 18101
Active, not recruiting
Beer Sheva, Israel, 8410101
Active, not recruiting
Haifa, Israel, 31096
Active, not recruiting
Haifa, Israel, 34362
Active, not recruiting
Holon, Israel, 58100
Completed
Jerusalem, Israel, 91120-01
Recruiting
Jerusalem, Israel, 9372212
Completed
Kfar Saba, Israel, 44281
Completed
Petach Tikva, Israel, 49100
Active, not recruiting
Ramat Gan, Israel, 52621
Active, not recruiting
Rehovot, Israel, 7610001
Completed
Tel Aviv, Israel, 64239-06
Italy
Active, not recruiting
Napoli, Campania, Italy, 80131
Active, not recruiting
Bologna, Emilia-Romagna, Italy, 40138
Active, not recruiting
Meldola, Emilia-Romagna, Italy, 47014
Terminated
Roma, Lazio, Italy, 00157
Active, not recruiting
Roma, Lazio, Italy, 00128
Active, not recruiting
Genova, Liguria, Italy, 16128
Terminated
Brescia, Lombardia, Italy, 25123
Active, not recruiting
Milano, Lombardia, Italy, 20141
Active, not recruiting
Milano, Lombardia, Italy, 20162
Active, not recruiting
Monza, Lombardia, Italy, 20052
Active, not recruiting
Saronno, Lombardia, Italy, 21047
Active, not recruiting
Novara, Piemonte, Italy, 28100
Active, not recruiting
Torino, Piemonte, Italy, 10126
Active, not recruiting
Torino, Piemonte, Italy, 10128
Active, not recruiting
Palermo, Sicilia, Italy, 90146
Active, not recruiting
Firenze, Toscana, Italy, 50139
Active, not recruiting
Pisa, Toscana, Italy, 56126
Active, not recruiting
Perugia, Umbria, Italy, 06123
Active, not recruiting
Terni, Umbria, Italy, 05100
Kuwait
Completed
Shuwaikh, Kuwait, 70653
Latvia
Completed
Daugavpils, Latvia, 5417
Completed
Riga, Latvia, LV 1079
Completed
Riga, Latvia, LV-1002
Lithuania
Active, not recruiting
Kaunas, Lithuania, 50009
Active, not recruiting
Klaipeda, Lithuania, 92288
Active, not recruiting
Vilnius, Lithuania, 08660
Macedonia, The Former Yugoslav Republic of
Terminated
Bitola, Macedonia, The Former Yugoslav Republic of, 7000
Completed
Skopje, Macedonia, The Former Yugoslav Republic of, 1000
Mexico
Active, not recruiting
Distrito Federal, Mexico, 14080
Active, not recruiting
Oaxaca, Mexico, 68000
Active, not recruiting
Toluca, Mexico, 50180
Netherlands
Completed
Alkmaar, Netherlands, 1815 JD
Completed
Amsterdam, Netherlands, 1091 AC
Active, not recruiting
Apeldoorn, Netherlands, 7334 DZ
Completed
Blaricum, Netherlands, 1261 AN
Completed
Breda, Netherlands, 4819 EV
Completed
Capelle Ad Yssel, Netherlands, 2906 ZC
Active, not recruiting
Den Haag, Netherlands, 2512 VA
Active, not recruiting
Den Haag, Netherlands, 2545 CH
Completed
Deventer, Netherlands, 7416 SE
Completed
Dordrecht, Netherlands, 3318 AT
Completed
Eindhoven, Netherlands, 5623 EJ
Active, not recruiting
Leidschendam, Netherlands, 2262 BA
Active, not recruiting
Rotterdam, Netherlands, 3045 PM
Active, not recruiting
Sittard-Geleen, Netherlands, 6162 BG
Active, not recruiting
Utrecht, Netherlands, 3582 KE
Poland
Active, not recruiting
Bydgoszcz, Poland, 85-796
Completed
Warszawa, Poland, 03-242
Portugal
Active, not recruiting
Porto, Portugal, 4200-072
Romania
Active, not recruiting
Bucuresti, Romania, 022328
Active, not recruiting
Cluj Napoca, Romania, 400015
Active, not recruiting
Iasi, Romania, 700106
Russian Federation
Active, not recruiting
Barnaul, Russian Federation, 656049
Active, not recruiting
Moscow, Russian Federation, 115478
Active, not recruiting
Obninsk, Kaluzhskaya Region, Russian Federation, 249034
Active, not recruiting
Saint-Petersburg, Russian Federation, 197022
Active, not recruiting
Stavropol, Russian Federation, 355045
Active, not recruiting
UFA, Russian Federation, 450054
Saudi Arabia
Completed
Dammam, Saudi Arabia, 31444
Serbia
Active, not recruiting
Belgrade, Serbia, 11000
Active, not recruiting
Nis, Serbia, 18000
Slovakia
Active, not recruiting
Bratislava, Slovakia, 833 10
Active, not recruiting
Kosice, Slovakia, 04001
Slovenia
Active, not recruiting
Ljubljana, Slovenia, 1000
Active, not recruiting
Maribor, Slovenia, 2000
South Africa
Active, not recruiting
Durban, South Africa, 4058
Active, not recruiting
Johannesburg, South Africa, 2193
Active, not recruiting
Sandton, South Africa, 2196
Spain
Active, not recruiting
Elda, Alicante, Spain, 03600
Active, not recruiting
Oviedo, Asturias, Spain, 33006
Completed
Llerena (Badajoz), Badajoz, Spain, 06900
Terminated
Manresa, Barcelona, Spain, 08243
Active, not recruiting
Cádiz, Cadiz, Spain, 11009
Active, not recruiting
Jerez de La Frontera, Cadiz, Spain, 11407
Active, not recruiting
San Sebastian, Guipuzcoa, Spain, 20080
Active, not recruiting
San Sebastian de Los Reyes, Guipuzcoa, Spain, 28702
Active, not recruiting
Palma de Mallorca, Islas Baleares, Spain, 07198
Active, not recruiting
Palma De Mallorca, Islas Baleares, Spain, 07014
Active, not recruiting
Santiago de Compostela, La Coruña, Spain, 15706
Completed
Las Palmas de Gran Canaria, Las Palmas, Spain, 35020
Active, not recruiting
Leganes, Madrid, Spain, 28911
Active, not recruiting
Reus, Tarragona, Spain, 43204
Active, not recruiting
La Laguna, Tenerife, Spain, 38320
Active, not recruiting
Santa Cruz de Tenerife, Tenerife, Spain, 38010
Terminated
San Juan, Valencia, Spain, 03550
Active, not recruiting
Barakaldo, Vizcaya, Spain, 48903
Active, not recruiting
Bilbao, Vizcaya, Spain, 48013
Active, not recruiting
Albacete, Spain, 02006
Active, not recruiting
Alicante, Spain, 3010
Terminated
Badajoz, Spain, 06080
Active, not recruiting
Barcelona, Spain, 08017
Active, not recruiting
Barcelona, Spain, 08036
Active, not recruiting
Barcelona, Spain, 08906
Active, not recruiting
Barcelona, Spain, 08003
Active, not recruiting
Burgos, Spain, 09006
Active, not recruiting
Caceres, Spain, 10003
Active, not recruiting
Castellon, Spain, 12002
Completed
Ciudad Real, Spain, 13005
Active, not recruiting
Cordoba, Spain, 14004
Active, not recruiting
Girona, Spain, 17007
Active, not recruiting
Granada, Spain, 18014
Terminated
Guadalajara, Spain, 19002
Active, not recruiting
Jaen, Spain, 23007
Active, not recruiting
La Coruña, Spain, 15006
Terminated
Lugo, Spain, 27003
Active, not recruiting
Madrid, Spain, 28007
Completed
Madrid, Spain, 28002
Active, not recruiting
Madrid, Spain, 28040
Active, not recruiting
Madrid, Spain, 28033
Active, not recruiting
Madrid, Spain, 28050
Active, not recruiting
Madrid, Spain, 28222
Active, not recruiting
Madrid, Spain, 28041
Active, not recruiting
Malaga, Spain, 29011
Active, not recruiting
Malaga, Spain, 29010
Active, not recruiting
Navarra, Spain, 31008
Active, not recruiting
Salamanca, Spain, 37007
Terminated
Segovia, Spain, 40002
Active, not recruiting
Sevilla, Spain, 41009
Active, not recruiting
Sevilla, Spain, 41014
Active, not recruiting
Toledo, Spain, 45004
Completed
Valencia, Spain, 46017
Active, not recruiting
Valencia, Spain, 46026
Active, not recruiting
Valencia, Spain, 46015
Active, not recruiting
Valencia, Spain, 46009
Completed
Valladolid, Spain, 47010
Active, not recruiting
Zaragoza, Spain, 50009
Sweden
Active, not recruiting
Eskilstuna, Sweden, 63188
Active, not recruiting
Falun, Sweden, 79182
Active, not recruiting
Karlstad, Sweden, 65185
Active, not recruiting
Umeå, Sweden
Active, not recruiting
Uppsala, Sweden, 75185
Active, not recruiting
Örebro, Sweden, 701 85
Switzerland
Completed
Aarau, Switzerland, 5001
Active, not recruiting
Baden, Switzerland, 5405
Active, not recruiting
Bellinzona, Switzerland, 6500
Completed
Bern, Switzerland, 3010
Recruiting
Genève 14, Switzerland, 1211
Active, not recruiting
Zürich, Switzerland, 8091
Taiwan
Active, not recruiting
Taipei City, Taiwan, 110
Active, not recruiting
Taipei City, Taiwan, 112
Active, not recruiting
Taoyuan City, Taiwan, 333
Turkey
Terminated
Ankara, Turkey, 06500
Active, not recruiting
Ankara, Turkey, 06230
Active, not recruiting
Diyarbakir, Turkey, 10000
Active, not recruiting
Istanbul, Turkey, 34390
Uruguay
Completed
Montevideo, Uruguay, 11600
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01239732     History of Changes
Other Study ID Numbers: MO22923, 2010-019525-34
Study First Received: November 10, 2010
Last Updated: August 19, 2014
Health Authority: Serbia: Agency for Drugs and Medicinal Devices

Additional relevant MeSH terms:
Ovarian Neoplasms
Fallopian Tube Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Fallopian Tube Diseases
Bevacizumab
Carboplatin
Paclitaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors

ClinicalTrials.gov processed this record on August 21, 2014