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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01239732
First received: November 10, 2010
Last updated: November 17, 2014
Last verified: November 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 ]

Enrollment: 1043
Study Start Date: December 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 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

  Hide Study Locations
Locations
Argentina
Buenos Aires, Argentina, C1199ACI
Buenos Aires, Argentina, C1426ANZ
Buenos Aires, Argentina, C1280AEB
Rosario, Argentina, S2002KDS
Tucuman, Argentina, T4000IAK
Austria
Graz, Austria, 8036
Graz, Austria, 8020
Innsbruck, Austria, 6020
Ried-innkreis, Austria, 4910
Salzburg, Austria, 5020
Steyr, Austria, 4400
Villach, Austria, 9500
Wien, Austria, 1090
Wien, Austria, 1130
Brazil
Salvador, BA, Brazil, 41950-610
Fortaleza, CE, Brazil, 60125-120
Goiania, GO, Brazil, 74605-070
Curitiba, PR, Brazil, 80530-010
Rio de Janeiro, RJ, Brazil, 20230-130
Porto Alegre, RS, Brazil, 90430-090
Porto Alegre, RS, Brazil, 90020-090
Piracicaba, SP, Brazil, 13419-155
Sao Paulo, SP, Brazil, 01509-010
Sao Paulo, SP, Brazil, 01317-000
Sao Paulo, SP, Brazil, 01246-000
Sao Paulo, SP, Brazil, 01308-050
Bulgaria
Sofia, Bulgaria, 1756
Varna, Bulgaria, 9010
Veliko Tarnovo, Bulgaria, 5000
Canada, Alberta
Calgary, Alberta, Canada, T2N 4N2
Canada, Ontario
Ottawa, Ontario, Canada, K1H 8L6
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
Montreal, Quebec, Canada, H2L 4M1
Canada
Quebec, Canada, G1R 2J6
Denmark
Aalborg, Denmark, 9000
Roskilde, Denmark, 4000
Vejle, Denmark, 7100
Egypt
Cairo, Egypt, 11555
Tanta, Egypt
Estonia
Tallinn, Estonia, 13419
Tallinn, Estonia, 11312
Tartu, Estonia, 50406
France
Amiens, France, 80090
Bordeaux, France, 33076
Brest, France, 29200
Caen, France, 14076
Clermont Ferrand, France, 63011
Grenoble, France, 38028
Lille, France, 59020
Lyon, France, 69373
Marseille, France, 13273
Mougins, France, 06250
Paris, France, 75908
Paris, France, 75231
Paris, France, 75571
Paris, France, 75651
Paris, France, 75674
Paris, France, 75970
Reims CEDEX, France, 51056
Strasbourg, France, 67065
Toulouse, France, 31059
Villejuif, France, 94805
Greece
Athens, Greece, 115 28
Athens, Greece, 14564
Athens, Greece, 11527
Heraklion, Greece, 711 10
Larissa, Greece, 41 110
Patras, Greece, 265 00
Thessaloniki, Greece, 56429
Hong Kong
Hong Kong, Hong Kong
Hungary
Budapest, Hungary, 1125
Budapest, Hungary, 1122
Debrecen, Hungary, 4032
Pecs, Hungary, 7624
Szeged, Hungary, 6720
India
Bangalore, India, 560054
Bangalore, India, 560017
Hyderabad, India, 650034
Jaipur, India, 302013
Kochi, India, 682304
New Delhi, India, 110029
Pune, India, 411004
Ireland
Dublin, Ireland, 7
Israel
Afula, Israel, 18101
Beer Sheva, Israel, 8410101
Haifa, Israel, 34362
Haifa, Israel, 31096
Holon, Israel, 58100
Jerusalem, Israel, 91120-01
Jerusalem, Israel, 9372212
Kfar Saba, Israel, 44281
Petach Tikva, Israel, 49100
Ramat Gan, Israel, 52621
Rehovot, Israel, 7610001
Tel Aviv, Israel, 64239-06
Italy
Napoli, Campania, Italy, 80131
Bologna, Emilia-Romagna, Italy, 40138
Meldola, Emilia-Romagna, Italy, 47014
Roma, Lazio, Italy, 00157
Roma, Lazio, Italy, 00128
Genova, Liguria, Italy, 16128
Brescia, Lombardia, Italy, 25123
Milano, Lombardia, Italy, 20141
Milano, Lombardia, Italy, 20162
Monza, Lombardia, Italy, 20052
Saronno, Lombardia, Italy, 21047
Novara, Piemonte, Italy, 28100
Torino, Piemonte, Italy, 10126
Torino, Piemonte, Italy, 10128
Palermo, Sicilia, Italy, 90146
Firenze, Toscana, Italy, 50139
Pisa, Toscana, Italy, 56126
Perugia, Umbria, Italy, 06123
Terni, Umbria, Italy, 05100
Kuwait
Shuwaikh, Kuwait, 70653
Latvia
Daugavpils, Latvia, 5417
Riga, Latvia, LV-1002
Riga, Latvia, LV 1079
Lithuania
Kaunas, Lithuania, 50009
Klaipeda, Lithuania, 92288
Vilnius, Lithuania, 08660
Macedonia, The Former Yugoslav Republic of
Bitola, Macedonia, The Former Yugoslav Republic of, 7000
Skopje, Macedonia, The Former Yugoslav Republic of, 1000
Mexico
Distrito Federal, Mexico, 14080
Oaxaca, Mexico, 68000
Toluca, Mexico, 50180
Netherlands
Alkmaar, Netherlands, 1815 JD
Amsterdam, Netherlands, 1091 AC
Apeldoorn, Netherlands, 7334 DZ
Blaricum, Netherlands, 1261 AN
Breda, Netherlands, 4819 EV
Capelle a/d IJssel, Netherlands, NL 2900 AR
Den Haag, Netherlands, 2512 VA
Den Haag, Netherlands, 2545 CH
Deventer, Netherlands, 7416 SE
Dordrecht, Netherlands, 3318 AT
Eindhoven, Netherlands, 5623 EJ
Leidschendam, Netherlands, 2262 BA
Rotterdam, Netherlands, 3045 PM
Sittard-Geleen, Netherlands, 6162 BG
Utrecht, Netherlands, 3582 KE
Poland
Bydgoszcz, Poland, 85-796
Warszawa, Poland, 03-242
Portugal
Porto, Portugal, 4200-072
Romania
Bucuresti, Romania, 022328
Cluj Napoca, Romania, 400015
Iasi, Romania, 700106
Russian Federation
Barnaul, Russian Federation, 656049
Moscow, Russian Federation, 115478
Obninsk, Kaluzhskaya Region, Russian Federation, 249034
Saint-Petersburg, Russian Federation, 197022
Stavropol, Russian Federation, 355045
UFA, Russian Federation, 450054
Saudi Arabia
Dammam, Saudi Arabia, 31444
Serbia
Belgrade, Serbia, 11000
Nis, Serbia, 18000
Slovakia
Bratislava, Slovakia, 833 10
Kosice, Slovakia, 04001
Slovenia
Ljubljana, Slovenia, 1000
Maribor, Slovenia, 2000
South Africa
Durban, South Africa, 4058
Johannesburg, South Africa, 2193
Sandton, South Africa, 2196
Spain
Elda, Alicante, Spain, 03600
Oviedo, Asturias, Spain, 33011
Llerena (Badajoz), Badajoz, Spain, 06900
Manresa, Barcelona, Spain, 08243
Cádiz, Cadiz, Spain, 11009
Jerez de La Frontera, Cadiz, Spain, 11407
San Sebastian, Guipuzcoa, Spain, 20080
San Sebastian de Los Reyes, Guipuzcoa, Spain, 28702
Palma De Mallorca, Islas Baleares, Spain, 07014
Palma de Mallorca, Islas Baleares, Spain, 07198
Santiago de Compostela, La Coruña, Spain, 15706
Las Palmas de Gran Canaria, Las Palmas, Spain, 35020
Leganes, Madrid, Spain, 28911
Reus, Tarragona, Spain, 43204
La Laguna, Tenerife, Spain, 38320
Santa Cruz de Tenerife, Tenerife, Spain, 38010
San Juan, Valencia, Spain, 03550
Barakaldo, Vizcaya, Spain, 48903
Bilbao, Vizcaya, Spain, 48013
Albacete, Spain, 02006
Alicante, Spain, 3010
Badajoz, Spain, 06080
Barcelona, Spain, 08017
Barcelona, Spain, 08036
Barcelona, Spain, 08906
Barcelona, Spain, 08003
Burgos, Spain, 09006
Caceres, Spain, 10003
Castellon, Spain, 12002
Ciudad Real, Spain, 13005
Cordoba, Spain, 14004
Girona, Spain, 17007
Granada, Spain, 18014
Guadalajara, Spain, 19002
Jaen, Spain, 23007
La Coruña, Spain, 15006
Lugo, Spain, 27003
Madrid, Spain, 28041
Madrid, Spain, 28002
Madrid, Spain, 28040
Madrid, Spain, 28007
Madrid, Spain, 28050
Madrid, Spain, 28222
Madrid, Spain, 28033
Malaga, Spain, 29011
Malaga, Spain, 29010
Navarra, Spain, 31008
Salamanca, Spain, 37007
Segovia, Spain, 40002
Sevilla, Spain, 41014
Sevilla, Spain, 41009
Toledo, Spain, 45004
Valencia, Spain, 46009
Valencia, Spain, 46026
Valencia, Spain, 46015
Valencia, Spain, 46017
Valladolid, Spain, 47010
Zaragoza, Spain, 50009
Sweden
Eskilstuna, Sweden, 63188
Falun, Sweden, 79182
Karlstad, Sweden, 65185
Umeå, Sweden
Uppsala, Sweden, 75185
Örebro, Sweden, 701 85
Switzerland
Aarau, Switzerland, 5001
Baden, Switzerland, 5405
Bellinzona, Switzerland, 6500
Bern, Switzerland, 3010
Genève 14, Switzerland, 1211
Zürich, Switzerland, 8091
Taiwan
Taipei City, Taiwan, 110
Taipei City, Taiwan, 112
Taoyuan City, Taiwan, 333
Turkey
Ankara, Turkey, 06500
Ankara, Turkey, 06230
Diyarbakir, Turkey, 10000
Istanbul, Turkey, 34390
Uruguay
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: November 17, 2014
Health Authority: Serbia: Agency for Drugs and Medicinal Devices

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

ClinicalTrials.gov processed this record on November 25, 2014