A Study of First Line Treatment With Avastin (Bevacizumab) in Combination With Carboplatin and Weekly Paclitaxel in Patients With Ovarian Cancer
A Single-arm Phase II Clinical Study Investigating the Addition of Bevacizumab to Carboplatin and Weekly Paclitaxel as First-line Treatment in Patients With Epithelial Ovarian Cancer
2 other identifiers
interventional
190
9 countries
55
Brief Summary
This single arm study evaluated the efficacy and safety of first-line chemotherapy with carboplatin and dose-dense weekly paclitaxel plus bevacizumab (Avastin) in participants with epithelial ovarian, fallopian tube, or primary peritoneal cancer. Participants received 6-8 3-week cycles of treatment with 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 (AUC) of 6 on day 1 of each cycle. Following combination chemotherapy, bevacizumab could be continued to be given as a monotherapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 ovarian-cancer
Started Jun 2009
Typical duration for phase_2 ovarian-cancer
55 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 25, 2009
CompletedFirst Submitted
Initial submission to the registry
July 6, 2009
CompletedFirst Posted
Study publicly available on registry
July 13, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2013
CompletedResults Posted
Study results publicly available
February 24, 2015
CompletedNovember 6, 2017
October 1, 2017
3.1 years
July 6, 2009
February 9, 2015
October 5, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Progression-free Survival
Progression-free survival was defined as the time from the first administration of any study treatment to the first disease progression using Response Evaluation Criteria In Solid Tumors (RECIST) or death from any cause, whichever occurred first.
Baseline to the data cut-off date of 19 Jul 2012 for analysis of the primary Outcome Measure (follow-up time up to 3 years, 1 month)
Secondary Outcomes (4)
Percentage of Participants With an Objective Response
Baseline to the data cut-off date of 19 Jul 2012 for analysis of the primary Outcome Measure (follow-up time up to 3 years, 1 month)
Duration of Response
Baseline to the data cut-off date of 19 Jul 2012 for analysis of the primary Outcome Measure (follow-up time up to 3 years, 1 month)
Overall Survival at 1 Year and 2 Years
Baseline to Year 2
Biological Progression-free Interval
Baseline to the data cut-off date of 19 Jul 2012 for analysis of the primary Outcome Measure (follow-up time up to 3 years, 1 month)
Study Arms (1)
Bevacizumab + paclitaxel + carboplatin
EXPERIMENTALParticipants 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.
Interventions
Bevacizumab was supplied as a sterile solution for infusion.
Paclitaxel was supplied locally in commercial batches.
Carboplatin was supplied locally in commercial batches.
Eligibility Criteria
You may qualify if:
- Female patients, ≥ 18 years of age.
- 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.
You may not qualify if:
- Non-epithelial tumors.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (55)
Hospital Amaral Carvalho
Jaú, São Paulo, 17210-080, Brazil
Hospital das Clinicas - FMUSP, Oncologia
São Paulo, São Paulo, 05403-000, Brazil
Centre Hospitalier Henri Duffaut; Hematologie
Avignon, 84902, France
Clinique Tivoli; Sce Radiotherapie
Bordeaux, 33000, France
Polyclinique Bordeaux Nord Aquitaine; Chimiotherapie Radiotherapie
Bordeaux, 33077, France
Ch De Brive La Gaillarde; Radiotherapie Oncologie
Brive-la-Gaillarde, 19312, France
Hopital Antoine Beclere; Service de Medecine Interne
Clamart, 92141, France
Centre Georges Francois Leclerc; Oncologie 3
Dijon, 21079, France
Chi Alpes Du Sud Site De Gap; Med Interne Et Polyvalente
Gap, 05000, France
Institut Daniel Hollard
Grenoble, 38000, France
Hôpital Saint Joseph; Oncologie Medicale
Marseille, 13285, France
CHRA;Hematologie
Metz-Tessy, 74370, France
Centre Antoine Lacassagne; Hopital De Jour A2
Nice, 06189, France
GH Paris Saint Joseph; Hopital De Jour Oncologie
Paris, 75674, France
HOPITAL TENON; Cancerologie Medicale
Paris, 75970, France
Hopital De La Miletrie; Hematologie Et Oncologie Medicale
Poitiers, 86021, France
Institut de Cancerologie de La Loire; Radiotherapie
Saint-Priest-en-Jarez, 42271, France
Centre Paul Strauss; Oncologie Medicale
Strasbourg, 67065, France
Institut Claudius Regaud; Departement Oncologie Medicale
Toulouse, 31059, France
Centre Alexis Vautrin; Oncologie Medicale
Vandœuvre-lès-Nancy, 54511, France
IRCCS Istituto Nazionale Tumori Fondazione Pascale; Oncologia Medica B
Napoli, Campania, 80131, Italy
A.O. Universitaria Policlinico Di Modena; Oncologia
Modena, Emilia-Romagna, 41100, Italy
Universita' Cattolica Del Sacro Cuore; Reparto Ginecologia Oncologica
Rome, Lazio, 00168, Italy
Universita' Cattolica Del Sacro Cuore; Reparto Ginecologia Oncologica
Campobasso, Molise, 86100, Italy
Medisch Centrum Alkmaar
Alkmaar, 1815 JD, Netherlands
Academisch Medisch Centrum; Inwendige Geneeskunde
Amsterdam, 1105 AZ, Netherlands
Medisch Spectrum Twente Enschede; Internal Medicine
Enschede, 7511 JX, Netherlands
Academ Ziekenhuis Groningen; Medical Oncology
Groningen, 9713 GZ, Netherlands
Mc Haaglanden, Locatie Antoniushove; Interne Geneeskunde
Leidschendam, 2262 BA, Netherlands
Sint Elizabeth Ziekenhuis; Inwendige Geneeskunde
Tilburg, 5022 GC, Netherlands
Isala Klinieken, Locatie Sophia; Inwendige Geneeskunde
Zwolle, 8025 AB, Netherlands
The Norvegian Radium Hospital Montebello; Dept of Oncology
Oslo, 0379, Norway
St. Olavs Hospital; Kvinneklinikken
Trondheim, 7006, Norway
Regional Clinical Oncology Dispensary
Krasnodar, 350040, Russia
Oncology Hospital; Chemotherapy Dept.
Moscow, 107005, Russia
Russian Oncology Research Center n.a. N.N. Blokhin Dpt of Clinical Pharmacology and Chemotherapy
Moscow, 115478, Russia
City Clinical Oncology Hospital
Moscow, 143423, Russia
Medical Radiological Scientific Center; Department of Radiotherapy of Gynaecological Disease
Obninsk, Kaluzhskaya Region, 249034, Russia
St. Petersburg Oncology & Gynecology; City Clinical Oncology Dispensary
Saint Petersburg, 197022, Russia
SBI of Healthcare of Stavropol region Stavropol Regional Clinical Oncology Dispensary
Stavropol, 355045, Russia
Hospital Univ Vall d'Hebron; Servicio de Oncologia
Barcelona, 08035, Spain
Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia
Barcelona, 08041, Spain
Hospital General Universitario Gregorio Marañon; Servicio de Oncologia
Madrid, 28007, Spain
Centro Oncologico MD Anderson Internacional; Servicio de Oncologia
Madrid, 28033, Spain
Hospital Universitario Clínico San Carlos; Servicio de Oncologia
Madrid, 28040, Spain
Hospital Universitario La Paz; Servicio de Oncologia
Madrid, 28046, Spain
Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia
Málaga, 29010, Spain
Instituto Valenciano Oncologia; Oncologia Medica
Valencia, 46009, Spain
Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia
Valencia, 46010, Spain
Sahlgrenska Universitetssjukhuset; Onkology
Gothenburg, SE-41 343, Sweden
Uni Hospital Linkoeping; Dept. of Oncology
Linköping, 58185, Sweden
Örebro University Hospital; Department of Gynecologic Oncology
Örebro, 70185, Sweden
Norrlands Uni Hospital; Onkologi Avd.
Umeå, 90185, Sweden
Akademiska sjukhuset, Onkologkliniken
Uppsala, 75185, Sweden
Royal Marsden Hospital; Dept of Med-Onc
London, SW3 6JJ, United Kingdom
Related Publications (1)
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.
PMID: 24007819DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann-La Roche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 6, 2009
First Posted
July 13, 2009
Study Start
June 25, 2009
Primary Completion
July 31, 2012
Study Completion
July 1, 2013
Last Updated
November 6, 2017
Results First Posted
February 24, 2015
Record last verified: 2017-10