Clinical trial NCT00937560: A Study of First Line Treatment With Avastin (Bevacizumab) in Combination With Carboplatin and Weekly Paclitaxel in Patients With Ovarian Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ovarian Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2009-07-13
Enrollment: 190
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria

* 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.

Exclusion Criteria

* 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.

Primary outcomes:
measure: Progression-free Survival
timeFrame: 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:
measure: Percentage of Participants With an Objective Response
timeFrame: 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)
measure: Duration of Response
timeFrame: 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)
measure: Overall Survival at 1 Year and 2 Years
timeFrame: Baseline to Year 2
measure: Biological Progression-free Interval
timeFrame: 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)
Other outcomes:
Locations:
city: Jau
country: Brazil
facility: Hospital Amaral Carvalho
state: SP
city: Sao Paulo
country: Brazil
facility: Hospital das Clinicas - FMUSP, Oncologia
state: SP
city: Avignon
country: France
facility: Centre Hospitalier Henri Duffaut; Hematologie
city: Bordeaux
country: France
facility: Clinique Tivoli; Sce Radiotherapie
city: Bordeaux
country: France
facility: Polyclinique Bordeaux Nord Aquitaine; Chimiotherapie Radiotherapie
city: Brive La Gaillarde
country: France
facility: Ch De Brive La Gaillarde; Radiotherapie Oncologie
city: Clamart
country: France
facility: Hopital Antoine Beclere; Service de Medecine Interne
city: Dijon
country: France
facility: Centre Georges Francois Leclerc; Oncologie 3
city: GAP
country: France
facility: Chi Alpes Du Sud Site De Gap; Med Interne Et Polyvalente
city: Grenoble
country: France
facility: Institut Daniel Hollard
city: Marseille
country: France
facility: Hôpital Saint Joseph; Oncologie Medicale
city: Metz Tessy
country: France
facility: CHRA;Hematologie
city: Nice
country: France
facility: Centre Antoine Lacassagne; Hopital De Jour A2
city: Paris
country: France
facility: GH Paris Saint Joseph; Hopital De Jour Oncologie
city: Paris
country: France
facility: HOPITAL TENON; Cancerologie Medicale
city: Poitiers
country: France
facility: Hopital De La Miletrie; Hematologie Et Oncologie Medicale
city: St Priest En Jarez
country: France
facility: Institut de Cancerologie de La Loire; Radiotherapie
city: Strasbourg
country: France
facility: Centre Paul Strauss; Oncologie Medicale
city: Toulouse
country: France
facility: Institut Claudius Regaud; Departement Oncologie Medicale
city: Vandoeuvre Les Nancy
country: France
facility: Centre Alexis Vautrin; Oncologie Medicale
city: Napoli
country: Italy
facility: IRCCS Istituto Nazionale Tumori Fondazione Pascale; Oncologia Medica B
state: Campania
city: Modena
country: Italy
facility: A.O. Universitaria Policlinico Di Modena; Oncologia
state: Emilia-Romagna
city: Roma
country: Italy
facility: Universita' Cattolica Del Sacro Cuore; Reparto Ginecologia Oncologica
state: Lazio
city: Campobasso
country: Italy
facility: Universita' Cattolica Del Sacro Cuore; Reparto Ginecologia Oncologica
state: Molise
city: Alkmaar
country: Netherlands
facility: Medisch Centrum Alkmaar
city: Amsterdam
country: Netherlands
facility: Academisch Medisch Centrum; Inwendige Geneeskunde
city: Enschede
country: Netherlands
facility: Medisch Spectrum Twente Enschede; Internal Medicine
city: Groningen
country: Netherlands
facility: Academ Ziekenhuis Groningen; Medical Oncology
city: Leidschendam
country: Netherlands
facility: Mc Haaglanden, Locatie Antoniushove; Interne Geneeskunde
city: Tilburg
country: Netherlands
facility: Sint Elizabeth Ziekenhuis; Inwendige Geneeskunde
city: Zwolle
country: Netherlands
facility: Isala Klinieken, Locatie Sophia; Inwendige Geneeskunde
city: Oslo
country: Norway
facility: The Norvegian Radium Hospital Montebello; Dept of Oncology
city: Trondheim
country: Norway
facility: St. Olavs Hospital; Kvinneklinikken
city: Krasnodar
country: Russian Federation
facility: Regional Clinical Oncology Dispensary
city: Moscow
country: Russian Federation
facility: Oncology Hospital; Chemotherapy Dept.
city: Moscow
country: Russian Federation
facility: Russian Oncology Research Center n.a. N.N. Blokhin Dpt of Clinical Pharmacology and Chemotherapy
city: Moscow
country: Russian Federation
facility: City Clinical Oncology Hospital
city: Obninsk, Kaluzhskaya Region
country: Russian Federation
facility: Medical Radiological Scientific Center; Department of Radiotherapy of Gynaecological Disease
city: Saint-Petersburg
country: Russian Federation
facility: St. Petersburg Oncology & Gynecology; City Clinical Oncology Dispensary
city: Stavropol
country: Russian Federation
facility: SBI of Healthcare of Stavropol region Stavropol Regional Clinical Oncology Dispensary
city: Barcelona
country: Spain
facility: Hospital Univ Vall d'Hebron; Servicio de Oncologia
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañon; Servicio de Oncologia
city: Madrid
country: Spain
facility: Centro Oncologico MD Anderson Internacional; Servicio de Oncologia
city: Madrid
country: Spain
facility: Hospital Universitario Clínico San Carlos; Servicio de Oncologia
city: Madrid
country: Spain
facility: Hospital Universitario La Paz; Servicio de Oncologia
city: Malaga
country: Spain
facility: Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia
city: Valencia
country: Spain
facility: Instituto Valenciano Oncologia; Oncologia Medica
city: Valencia
country: Spain
facility: Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia
city: Gothenburg
country: Sweden
facility: Sahlgrenska Universitetssjukhuset; Onkology
city: Linköping
country: Sweden
facility: Uni Hospital Linkoeping; Dept. of Oncology
city: Umea
country: Sweden
facility: Norrlands Uni Hospital; Onkologi Avd.
city: Uppsala
country: Sweden
facility: Akademiska sjukhuset, Onkologkliniken
city: Örebro
country: Sweden
facility: Örebro University Hospital; Department of Gynecologic Oncology
city: London
country: United Kingdom
facility: Royal Marsden Hospital; Dept of Med-Onc
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.