A Study of First Line Treatment With Avastin (Bevacizumab) in Combination With Carboplatin and Weekly Paclitaxel in Patients With Ovarian Cancer
NCT ID: NCT00937560
Last Updated: 2017-11-06
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE2
190 participants
INTERVENTIONAL
2009-06-25
2013-07-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Bevacizumab + paclitaxel + carboplatin
Participants received 6-8 (at the investigator's discretion) 3-week cycles of bevacizumab 7.5 mg/kg intravenously (iv) on Day 1 of each cycle, paclitaxel 80 mg/m\^2 iv on Days 1, 8, and 15 of each cycle, and carboplatin iv to an area under the curve of 6 on Day 1 of each cycle. The initial dose of carboplatin was calculated according to the Calvert formula (mg = \[glomerular filtration rate + 25\] x 6). Following the combination treatments, participants received up to 17 3-week cycles of bevacizumab 7.5 mg/g iv alone.
Bevacizumab
Bevacizumab was supplied as a sterile solution for infusion.
Paclitaxel
Paclitaxel was supplied locally in commercial batches.
Carboplatin
Carboplatin was supplied locally in commercial batches.
Interventions
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Bevacizumab
Bevacizumab was supplied as a sterile solution for infusion.
Paclitaxel
Paclitaxel was supplied locally in commercial batches.
Carboplatin
Carboplatin was supplied locally in commercial batches.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Epithelial ovarian, fallopian tube, or primary peritoneal cancer.
* Initial surgery, but no chemotherapy or radiotherapy.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
Exclusion Criteria
* Ovarian tumors with low malignant potential.
* Previous systemic anti-cancer therapy for ovarian cancer.
* History or evidence of synchronous primary endometrial cancer.
* Current or recent daily treatment with aspirin (\> 325mg/day) or with full dose anticoagulant or thrombolytic agents for therapeutic purposes.
18 Years
FEMALE
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Hospital Amaral Carvalho
Jaú, São Paulo, Brazil
Hospital das Clinicas - FMUSP, Oncologia
São Paulo, São Paulo, Brazil
Centre Hospitalier Henri Duffaut; Hematologie
Avignon, , France
Clinique Tivoli; Sce Radiotherapie
Bordeaux, , France
Polyclinique Bordeaux Nord Aquitaine; Chimiotherapie Radiotherapie
Bordeaux, , France
Ch De Brive La Gaillarde; Radiotherapie Oncologie
Brive-la-Gaillarde, , France
Hopital Antoine Beclere; Service de Medecine Interne
Clamart, , France
Centre Georges Francois Leclerc; Oncologie 3
Dijon, , France
Chi Alpes Du Sud Site De Gap; Med Interne Et Polyvalente
Gap, , France
Institut Daniel Hollard
Grenoble, , France
Hôpital Saint Joseph; Oncologie Medicale
Marseille, , France
CHRA;Hematologie
Metz-Tessy, , France
Centre Antoine Lacassagne; Hopital De Jour A2
Nice, , France
GH Paris Saint Joseph; Hopital De Jour Oncologie
Paris, , France
HOPITAL TENON; Cancerologie Medicale
Paris, , France
Hopital De La Miletrie; Hematologie Et Oncologie Medicale
Poitiers, , France
Institut de Cancerologie de La Loire; Radiotherapie
Saint-Priest-en-Jarez, , France
Centre Paul Strauss; Oncologie Medicale
Strasbourg, , France
Institut Claudius Regaud; Departement Oncologie Medicale
Toulouse, , France
Centre Alexis Vautrin; Oncologie Medicale
Vandœuvre-lès-Nancy, , France
IRCCS Istituto Nazionale Tumori Fondazione Pascale; Oncologia Medica B
Napoli, Campania, Italy
A.O. Universitaria Policlinico Di Modena; Oncologia
Modena, Emilia-Romagna, Italy
Universita' Cattolica Del Sacro Cuore; Reparto Ginecologia Oncologica
Rome, Lazio, Italy
Universita' Cattolica Del Sacro Cuore; Reparto Ginecologia Oncologica
Campobasso, Molise, Italy
Medisch Centrum Alkmaar
Alkmaar, , Netherlands
Academisch Medisch Centrum; Inwendige Geneeskunde
Amsterdam, , Netherlands
Medisch Spectrum Twente Enschede; Internal Medicine
Enschede, , Netherlands
Academ Ziekenhuis Groningen; Medical Oncology
Groningen, , Netherlands
Mc Haaglanden, Locatie Antoniushove; Interne Geneeskunde
Leidschendam, , Netherlands
Sint Elizabeth Ziekenhuis; Inwendige Geneeskunde
Tilburg, , Netherlands
Isala Klinieken, Locatie Sophia; Inwendige Geneeskunde
Zwolle, , Netherlands
The Norvegian Radium Hospital Montebello; Dept of Oncology
Oslo, , Norway
St. Olavs Hospital; Kvinneklinikken
Trondheim, , Norway
Regional Clinical Oncology Dispensary
Krasnodar, , Russia
Oncology Hospital; Chemotherapy Dept.
Moscow, , Russia
Russian Oncology Research Center n.a. N.N. Blokhin Dpt of Clinical Pharmacology and Chemotherapy
Moscow, , Russia
City Clinical Oncology Hospital
Moscow, , Russia
Medical Radiological Scientific Center; Department of Radiotherapy of Gynaecological Disease
Obninsk, Kaluzhskaya Region, , Russia
St. Petersburg Oncology & Gynecology; City Clinical Oncology Dispensary
Saint Petersburg, , Russia
SBI of Healthcare of Stavropol region Stavropol Regional Clinical Oncology Dispensary
Stavropol, , Russia
Hospital Univ Vall d'Hebron; Servicio de Oncologia
Barcelona, , Spain
Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia
Barcelona, , Spain
Hospital General Universitario Gregorio Marañon; Servicio de Oncologia
Madrid, , Spain
Centro Oncologico MD Anderson Internacional; Servicio de Oncologia
Madrid, , Spain
Hospital Universitario Clínico San Carlos; Servicio de Oncologia
Madrid, , Spain
Hospital Universitario La Paz; Servicio de Oncologia
Madrid, , Spain
Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia
Málaga, , Spain
Instituto Valenciano Oncologia; Oncologia Medica
Valencia, , Spain
Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia
Valencia, , Spain
Sahlgrenska Universitetssjukhuset; Onkology
Gothenburg, , Sweden
Uni Hospital Linkoeping; Dept. of Oncology
Linköping, , Sweden
Örebro University Hospital; Department of Gynecologic Oncology
Örebro, , Sweden
Norrlands Uni Hospital; Onkologi Avd.
Umeå, , Sweden
Akademiska sjukhuset, Onkologkliniken
Uppsala, , Sweden
Royal Marsden Hospital; Dept of Med-Onc
London, , United Kingdom
Countries
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References
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Gonzalez-Martin A, Gladieff L, Tholander B, Stroyakovsky D, Gore M, Scambia G, Kovalenko N, Oaknin A, Ronco JP, Freudensprung U, Pignata S; OCTAVIA Investigators. Efficacy and safety results from OCTAVIA, a single-arm phase II study evaluating front-line bevacizumab, carboplatin and weekly paclitaxel for ovarian cancer. Eur J Cancer. 2013 Dec;49(18):3831-8. doi: 10.1016/j.ejca.2013.08.002. Epub 2013 Sep 2.
Other Identifiers
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2008-008336-85
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
MO22225
Identifier Type: -
Identifier Source: org_study_id