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AURELIA: A Study of Avastin (Bevacizumab) Added to Chemotherapy in Patients With Platinum-resistant Ovarian Cancer

Primary Purpose

Ovarian Cancer

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Bevacizumab
liposomal doxorubicin
paclitaxel
topotecan
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • female patients, >/=18 years of age
  • epithelial ovarian, fallopian tube or primary peritoneal cancer
  • platinum-resistant disease (disease progression within <6 months of platinum therapy)
  • EOCG performance status of 0-2

Exclusion Criteria:

  • non-epithelial tumours
  • ovarian tumours with low malignant potential
  • previous treatment with >2 chemotherapy regimens
  • prior radiotherapy to the pelvis or abdomen

Sites / Locations

  • Institut Jules Bordet
  • UZ Antwerpen
  • UZ Leuven Gasthuisberg
  • Clinique Ste-Elisabeth
  • University Clinical Centre of the Republic of Srpska
  • Clinic of Oncology, University Clinical Center Sarajevo
  • University Clinical Center Tuzla; Clinic for Gynecology and Obstetrition
  • Herlev Hospital; Afdeling for Kræftbehandling
  • Regionshospitalet Herning; Onkologisk afdeling
  • Rigshospitalet; Onkologisk Klinik
  • Odense Universitetshospital, Onkologisk Afdeling R
  • Kuopio University Hospital
  • Oulu University Hospital; Gynaecology & Obstetrics Dept
  • Clinique Sainte Catherine; Hopital De Semaine
  • Clinique Tivoli; Sce Radiotherapie
  • Institut Bergonie; Gynecologie
  • Polyclinique Bordeaux Nord Aquitaine; Chimiotherapie Radiotherapie
  • Ch De Brive La Gaillarde; Radiotherapie Oncologie
  • Centre Francois Baclesse; Urologie Gynecologie
  • Centre Jean Perrin; Hopital De Jour
  • Hopital Louis Pasteur; Medecine B
  • Institut Daniel Hollard; Chimiotherapie Ambulatoire
  • Centre Hospitalier Departemental Les Oudairies
  • Hopital La Source; Onco Med Hematologie Clinique
  • Hopital Andre Mignot; Hematologie - Oncologie
  • Centre Jean Bernard
  • Centre Oscar Lambret; Cancerologie Gynecologique
  • Clin Mut De Lyon Eugene Andre; Medecine 3 A
  • Hopital Layne; Medecine Ambulatoire
  • Centre Val Aurelle Paul Lamarque; Medecine A1 A2
  • Polyclinique Gentilly; CHIMIOTHERAPIE AMBULATOIRE
  • Centre Catherine de Sienne; Chimiotherapie
  • Centre Antoine Lacassagne; Hopital De Jour A2
  • Polyclinique Kenval ; Radiotherapie Oncologie
  • Hotel Dieu; Hematologie- Oncologie
  • Institut Curie; Oncologie Medicale
  • Hopital Saint Louis ; Service d Oncologie Medicale Fougere 6 (Pr Misset)
  • HOPITAL TENON; Cancerologie Medicale
  • Clinique Francheville; Radiotherapie
  • Institut Jean Godinot; Oncologie Medicale
  • Centre Henri Becquerel; Oncologie Medicale
  • Clinique Armoricaine Radiologie; Cons Externes
  • Ico Rene Gauducheau; Oncologie
  • Centre Radiotherapie Etienne Dolet
  • Centre Rene Huguenin; Medecine B
  • Hopital Civil; Expl Fonct Systeme Nerveux
  • Hopitaux Du Leman Site Thonon; Maternite Gynecologie
  • Institut Claudius Regaud; Departement Oncologie Medicale
  • Centre Alexis Vautrin; Oncologie Medicale
  • HELIOS Klinikum Berlin-Buch; Klinik für Gynäkologie und Geburtshilfe
  • Campus Virchow-Klinikum Charité; Centrum 17; Klinik für Gynäkologie
  • Evangelischen Krankenhauses Düsseldorf; Frauenklinik
  • Uni-Frauenklinik
  • Universitätsklinikum Erlangen; Frauenklinik
  • Universitätsklinikum Essen; Zentrum Für Frauenheilkunde
  • Klinikum Essen-Mitte Ev. Huyssens-Stiftung / Knappschafts GmbH; Klinik für Senologie / Brustzentrum
  • Klinik Johann Wolfgang von Goethe Uni; Klinik für Frauenheilkunde und Geburtshilfe
  • Kath.Marienkrankenhaus gGmbH Frauenklinik
  • Gynaekologisch-Onkologische Schwerpunktpraxis Prof. Dr. med. Lueck, Dr. Schrader und Dr. Noeding
  • Praxisgemeinschaft; Frauenärzte am Bahnhofsplatz
  • Klinikum Kassel GmbH; Klinik für Frauenheilkunde und Geburtshilfe
  • UNI-Klinikum Campus Kiel Klinik für Gynäkologie und Geburtshilfe
  • HELIOS Klinikum Krefeld; Klinik für Frauenheilkunde und Geburtshilfe
  • Universitätsklinikum Schleswig-Holstein / Campus Lübeck; Klinik für Frauenheilkunde und Geburtshilfe
  • Universitätsklinikum Mannheim; Frauenklinik
  • Klinikum der Universität München; Campus Großhadern; Klinik und Poliklinik für Frauenheilkunde
  • Klinikum Nord Frauenklinik
  • Sana Klinikum Offenbach GmbH; Klinik für Gynäkologie & Geburtshilfe
  • Oncologianova GmbH
  • Universitätsfrauen- und Poliklinik am Klinikum Suedstadt
  • Städtisches Klinikum Solingen; Klinik für Frauenheilkunde und Geburtshilfe
  • Robert-Bosch-Krankenhaus; Interdisziplinäres Zentrum; Tumorzentrum
  • Universitätsklinik Tübingen; Frauenklinik & Poliklinik
  • Universitätsklinikum Ulm Am Michelsberg; Frauenklinik
  • Dr. Horst-Schmidt-Kliniken; Frauenheilkunde & Geburtshilfe
  • University Hospital of Alexandra
  • Irccs Centro Di Riferimento Oncologico (CRO); Dipartimento Di Oncologia Medica
  • A.O. Universitaria S. Maria Della Misericordia Di Udine; Oncologia
  • AZIENDA POLICLINICO UMBERTO I; Ginecologia ed Ostetricia
  • Istituto Regina Elena; Oncologia Medica A
  • Ospedale S.G.Calibita Fatebenefratelli; Unità Operativa Oncologia
  • Ospedali Riuniti; Divisione Ostetricia e Ginecologia
  • Az. Osp. Carlo Poma; Divisione Di Oncologia Medica
  • Istituto Nazionale dei Tumori; Divisione Oncologia Chirurgica e Ginecologica
  • Meander Mc, Locatie Lichtenberg; Dept of Lung Diseases
  • Leyenburg Ziekenhuis; Internal Medecine
  • Catharina ZKHS; Inwendige Geneeskunde Afd.
  • Martini Ziekenhuis; Dept of Internal Medicine
  • Stichting St. Antonius Ziekenhuis
  • Universitair Medisch Centrum Utrecht; Inwendige Geneeskunde Afd.
  • The Norvegian Radium Hospital Montebello; Dept of Oncology
  • St. Olavs Hospital; Kvinneklinikken
  • IPO de Lisboa; Servico de Oncologia Medica
  • IPO do Porto; Servico de Oncologia Medica
  • Corporacio Sanitaria Parc Tauli; Servicio de Oncologia
  • Hospital Universitario Marques de Valdecilla; Servicio de Oncologia
  • Hospital Universitario Reina Sofia; Servicio de Oncologia
  • Hospital Son Llatzer; Servicio de Oncologia
  • Hospital Univ Vall d'Hebron; Servicio de Oncologia
  • Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia
  • Hospital de Terrassa; Servicio de Oncologia
  • Hospital Universitari Arnau de Vilanova de Lleida; Servicio de Oncologia
  • Hospital General Universitario Gregorio Marañon; Servicio de Oncologia
  • Centro Oncologico MD Anderson Internacional; Servicio de Oncologia
  • Centro Integral Oncologico Clara Campal (CIOCC); Dirección Médica
  • Hospital General Universitario J.M Morales Meseguer; Servicio de Oncologia
  • Instituto Valenciano Oncologia; Oncologia Medica
  • Hospital Universitario la Fe; Servicio de Oncologia
  • Hospital Universitario Miguel Servet; Servicio Oncologia
  • Uni Hospital Linkoeping; Dept. of Oncology
  • Norrlands Uni Hospital; Onkologi Avd.
  • Akademiska sjukhuset, Onkologkliniken
  • Örebro University Hospital; Department of Gynecologic Oncology
  • Adana Baskent University Hospital; Medical Oncology
  • Ankara Baskent University Medicine Faculty; Gynaecology
  • Istanbul Uni Cerrahpasa Medical Faculty Hospital; Medical Oncology
  • Anadolu Health Center; Medical Oncology

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Chemotherapy

Chemotherapy + Bevacizumab

Arm Description

Participants received one of the following chemotherapies at the discretion of the investigator: paclitaxel, 80 milligrams per square meter (mg/m^2) as a 1-hour intravenous (IV) infusion on Days 1, 8, 15, and 22 every 4 weeks (q4w) OR topotecan 4 mg/m^2 as a 30-minute IV infusion on Days 1, 8, and 15 q4w (alternatively, a 1.25 mg/m^2 dose could have been administered over 30 minutes on Days 1-5 every 3 weeks [q3w]) OR pegylated liposomal doxorubicin (PLD) 40 mg/m^2 as a 1 milligram per minute (mg/min) infusion on Day 1 q4w (after Cycle 1 the drug could have been administered as a 1 hour infusion). Depending on chosen chemotherapy, pre-medication was implemented according to local practices.

Participants received one of the following chemotherapies at the discretion of the investigator: paclitaxel, 80 mg/m^2 as a 1-hour IV infusion on Days 1, 8, 15, and 22 q4w OR topotecan 4 mg/m^2 as a 30-minute IV infusion on Days 1, 8, and 15 q4w (alternatively, a 1.25 mg/m^2 dose could have been administered over 30 minutes on Days 1-5 q3w) OR PLD 40 mg/m^2 as a 1 mg/min infusion on Day 1 q4w (after Cycle 1 the drug could have been administered as a 1 hour infusion. Depending on chosen chemotherapy, pre-medication was implemented according to local practices. The chosen chemotherapy was combined with bevacizumab 10 milligrams per kilogram (mg/kg) IV every 2 weeks (q2w; or bevacizumab 15 mg/kg q3w if used in combination with topotecan 1.25 mg/m^2 on Days 1-5 on a q3w schedule). The initial bevacizumab infusion was over 90 minutes, with subsequent infusions over 60 minutes and then 30 minutes, as tolerated.

Outcomes

Primary Outcome Measures

Percentage of Participants With Disease Progression or Death (Data Cutoff 14 November 2011)
Progression free survival was defined as the time from the date of randomization to the first documented disease progression or death, whichever occurs first. Progression was based on tumour assessment made by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST) criteria (for participants with measurable disease), and for those with non-measurable disease presence or absence of lesions was noted.
Progression Free Survival (PFS; Data Cutoff 14 November 2011)
PFS was defined as the time from the date of randomization to the first documented disease progression or death, whichever occurred first. Progression was based on tumor assessment made by the investigators according to the RECIST criteria (for participants with measurable disease), and for those with non-measurable disease presence or absence of lesions was noted. Time from randomization to occurrence of disease progression or death was measured in months. An event was defined as the earliest progressive disease or death that occurred on or before the cutoff date (14 November 2011), regardless of start of nonprotocol specified anti-cancer therapy or the bevacizumab monotherapy. Disease progression was assessed by investigator according to RECIST or by symptom deterioration, and could not be declared on the basis of rising cancer antigen 125 (CA125) levels alone. Kaplan-Meier methodology was used. 95% CI for median was computed using the method of Brookmeyer and Crowley.

Secondary Outcome Measures

Percentage of Participants With Best Overall Confirmed Objective Response of Complete Response (CR) or Partial Response (PR) Per Modified RECIST (Data Cutoff 14 November 2011)
Objective Response was determined by the investigator using modified RECIST criteria, Version 1.0. An objective response was a complete or partial overall confirmed response as determined by investigators. CR defined as complete disappearance of all target and non-target lesions and no new lesions. PR defined as greater than or equal to (≥) 30 percent (%) decrease in the sum of appropriate diameters of all target measurable lesions, no progress in the non-measurable disease, and no new lesions. 95% CI computed using the normal approximation to the binomial distribution.
Duration of Objective Response (Data Cutoff 14 November 2011)
For randomized participants who achieved an objective response per modified RECIST, duration of objective response was defined as the time from the date of the first occurrence of a CR or PR (whichever occurred first) until the date that progressive disease or death was documented (whichever occurred first). Participants who had an objective response and did not experience disease progression or death by the time of analysis were censored at the time of the last tumor assessment. Summaries of duration of objective response (median and percentiles) were estimated from Kaplan-Meier curves. 95% CI for duration of objective response was computed using the method of Brookmeyer and Crowley.
Percentage of Participants Who Died (Data Cutoff 25 January 2013)
Overall Survival (Data Cutoff 25 January 2013)
Duration of overall survival was defined as the time from randomization to death of any cause. Kaplan-Meier methodology was used. The OS data for participants for whom no death was captured in the clinical database were censored at the last time they were known to be alive. 95% CI was computed using the method of Brookmeyer and Crowley.
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) Ovarian (OV) 28 Abdominal/Gastrointestinal (AB/GI) Symptom Scale - Percentage of Responders (Data Cutoff 14 November 2011)
The EORTC OV-28 module is a questionnaire that focuses on issues specific to ovarian cancer. It assesses AB/GI symptoms, among others. Participants were asked to indicate the extent to which they experienced AB/GI symptoms in the week prior to assessment. Participants responded on a scale of 1-4 (1=not at all, 2=a little, 3=quite a bit, 4=very much) to the following: Did you have abdominal pain? Did you have a bloated feeling in your abdomen/stomach? Did you have problems with your clothes feeling too tight? Did you experience any change in bowel habit as a result of your disease or treatment? Were you troubled by passing wind/gas/flatulence? Have you felt full too quickly after beginning to eat? Have you had indigestion/heartburn? Data are transformed to a scale from 0 to 100. Lower scores represent better health (fewer symptoms). Participants were considered a responder if they had a 10 point or more reduction in EORTC QLQ-OV28 AB/GI symptom scale score from baseline.

Full Information

First Posted
September 14, 2009
Last Updated
May 5, 2022
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT00976911
Brief Title
AURELIA: A Study of Avastin (Bevacizumab) Added to Chemotherapy in Patients With Platinum-resistant Ovarian Cancer
Official Title
AURELIA: A Multi-center, Open-label, Randomised, Two-arm Phase III Trial of the Effect on Progression Free Survival of Bevacizumab Plus Chemotherapy Versus Chemotherapy Alone in Patients With Platinum-resistant, Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
October 29, 2009 (Actual)
Primary Completion Date
July 9, 2014 (Actual)
Study Completion Date
July 9, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche

4. Oversight

5. Study Description

Brief Summary
This randomized, open-label, 2-arm study will evaluate the efficacy and safety of Avastin added to chemotherapy versus chemotherapy alone in patients with epithelial ovarian, fallopian tube or primary peritoneal cancer with disease progression within 6 months of platinum therapy. All patients will receive standard chemotherapy with either paclitaxel or topotecan or liposomal doxorubicin. Patients randomized to Arm 2 of the study will receive Avastin (10 mg/kg iv 2-weekly or 15 mg/kg iv 3-weekly) concomitantly. Anticipated time on study treatment is until disease progression. Patients will then receive standard of care, those in Arm 1 (chemotherapy only) may opt to receive Avastin (15 mg/kg iv 3-weekly). Target sample size is 100-500 individuals.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
361 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Chemotherapy
Arm Type
Active Comparator
Arm Description
Participants received one of the following chemotherapies at the discretion of the investigator: paclitaxel, 80 milligrams per square meter (mg/m^2) as a 1-hour intravenous (IV) infusion on Days 1, 8, 15, and 22 every 4 weeks (q4w) OR topotecan 4 mg/m^2 as a 30-minute IV infusion on Days 1, 8, and 15 q4w (alternatively, a 1.25 mg/m^2 dose could have been administered over 30 minutes on Days 1-5 every 3 weeks [q3w]) OR pegylated liposomal doxorubicin (PLD) 40 mg/m^2 as a 1 milligram per minute (mg/min) infusion on Day 1 q4w (after Cycle 1 the drug could have been administered as a 1 hour infusion). Depending on chosen chemotherapy, pre-medication was implemented according to local practices.
Arm Title
Chemotherapy + Bevacizumab
Arm Type
Experimental
Arm Description
Participants received one of the following chemotherapies at the discretion of the investigator: paclitaxel, 80 mg/m^2 as a 1-hour IV infusion on Days 1, 8, 15, and 22 q4w OR topotecan 4 mg/m^2 as a 30-minute IV infusion on Days 1, 8, and 15 q4w (alternatively, a 1.25 mg/m^2 dose could have been administered over 30 minutes on Days 1-5 q3w) OR PLD 40 mg/m^2 as a 1 mg/min infusion on Day 1 q4w (after Cycle 1 the drug could have been administered as a 1 hour infusion. Depending on chosen chemotherapy, pre-medication was implemented according to local practices. The chosen chemotherapy was combined with bevacizumab 10 milligrams per kilogram (mg/kg) IV every 2 weeks (q2w; or bevacizumab 15 mg/kg q3w if used in combination with topotecan 1.25 mg/m^2 on Days 1-5 on a q3w schedule). The initial bevacizumab infusion was over 90 minutes, with subsequent infusions over 60 minutes and then 30 minutes, as tolerated.
Intervention Type
Drug
Intervention Name(s)
Bevacizumab
Other Intervention Name(s)
Avastin
Intervention Description
10m/kg iv every 2 weeks or 15mg/kg iv every 3 weeks
Intervention Type
Drug
Intervention Name(s)
liposomal doxorubicin
Intervention Description
40mg/m2 iv every 4 weeks
Intervention Type
Drug
Intervention Name(s)
paclitaxel
Intervention Description
80mg/m2 iv on days 1, 8, 15 and 22 of each 4-week cycle
Intervention Type
Drug
Intervention Name(s)
topotecan
Intervention Description
4mg/m2 iv on days 1, 8 and 15 of each 4-week cycle, or 1.25 mg/kg on days 1-5 of each 3-week cycle
Primary Outcome Measure Information:
Title
Percentage of Participants With Disease Progression or Death (Data Cutoff 14 November 2011)
Description
Progression free survival was defined as the time from the date of randomization to the first documented disease progression or death, whichever occurs first. Progression was based on tumour assessment made by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST) criteria (for participants with measurable disease), and for those with non-measurable disease presence or absence of lesions was noted.
Time Frame
Screening Visit, Every 8 weeks (or 9 weeks if receiving topotecan) until progression reported between day of first participant randomized (29 October 2009) until cutoff date of 14 November 2011
Title
Progression Free Survival (PFS; Data Cutoff 14 November 2011)
Description
PFS was defined as the time from the date of randomization to the first documented disease progression or death, whichever occurred first. Progression was based on tumor assessment made by the investigators according to the RECIST criteria (for participants with measurable disease), and for those with non-measurable disease presence or absence of lesions was noted. Time from randomization to occurrence of disease progression or death was measured in months. An event was defined as the earliest progressive disease or death that occurred on or before the cutoff date (14 November 2011), regardless of start of nonprotocol specified anti-cancer therapy or the bevacizumab monotherapy. Disease progression was assessed by investigator according to RECIST or by symptom deterioration, and could not be declared on the basis of rising cancer antigen 125 (CA125) levels alone. Kaplan-Meier methodology was used. 95% CI for median was computed using the method of Brookmeyer and Crowley.
Time Frame
Screening Visit, Every 8 weeks (or 9 weeks if receiving topotecan) until progression reported between day of first participant randomized (29 October 2009) until cutoff date of 14 November 2011
Secondary Outcome Measure Information:
Title
Percentage of Participants With Best Overall Confirmed Objective Response of Complete Response (CR) or Partial Response (PR) Per Modified RECIST (Data Cutoff 14 November 2011)
Description
Objective Response was determined by the investigator using modified RECIST criteria, Version 1.0. An objective response was a complete or partial overall confirmed response as determined by investigators. CR defined as complete disappearance of all target and non-target lesions and no new lesions. PR defined as greater than or equal to (≥) 30 percent (%) decrease in the sum of appropriate diameters of all target measurable lesions, no progress in the non-measurable disease, and no new lesions. 95% CI computed using the normal approximation to the binomial distribution.
Time Frame
Screening Visit, Every 8 weeks (or 9 weeks if receiving topotecan) until progression reported between day of first participant randomized (29 October 2009) until cutoff date of 14 November 2011
Title
Duration of Objective Response (Data Cutoff 14 November 2011)
Description
For randomized participants who achieved an objective response per modified RECIST, duration of objective response was defined as the time from the date of the first occurrence of a CR or PR (whichever occurred first) until the date that progressive disease or death was documented (whichever occurred first). Participants who had an objective response and did not experience disease progression or death by the time of analysis were censored at the time of the last tumor assessment. Summaries of duration of objective response (median and percentiles) were estimated from Kaplan-Meier curves. 95% CI for duration of objective response was computed using the method of Brookmeyer and Crowley.
Time Frame
Screening Visit, Every 8 weeks (or 9 weeks if receiving topotecan) until progression reported between day of first participant randomized (29 October 2009) until cutoff date of 14 November 2011
Title
Percentage of Participants Who Died (Data Cutoff 25 January 2013)
Time Frame
Screening Visit, Every 8 weeks (or 9 weeks if receiving topotecan) until progression reported between day of first participant randomized (29 October 2009) until cutoff date of 25 January 2013
Title
Overall Survival (Data Cutoff 25 January 2013)
Description
Duration of overall survival was defined as the time from randomization to death of any cause. Kaplan-Meier methodology was used. The OS data for participants for whom no death was captured in the clinical database were censored at the last time they were known to be alive. 95% CI was computed using the method of Brookmeyer and Crowley.
Time Frame
Screening Visit, Every 8 weeks (or 9 weeks if receiving topotecan) until progression reported between day of first participant randomized (29 October 2009) until cutoff date of 25 January 2013
Title
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) Ovarian (OV) 28 Abdominal/Gastrointestinal (AB/GI) Symptom Scale - Percentage of Responders (Data Cutoff 14 November 2011)
Description
The EORTC OV-28 module is a questionnaire that focuses on issues specific to ovarian cancer. It assesses AB/GI symptoms, among others. Participants were asked to indicate the extent to which they experienced AB/GI symptoms in the week prior to assessment. Participants responded on a scale of 1-4 (1=not at all, 2=a little, 3=quite a bit, 4=very much) to the following: Did you have abdominal pain? Did you have a bloated feeling in your abdomen/stomach? Did you have problems with your clothes feeling too tight? Did you experience any change in bowel habit as a result of your disease or treatment? Were you troubled by passing wind/gas/flatulence? Have you felt full too quickly after beginning to eat? Have you had indigestion/heartburn? Data are transformed to a scale from 0 to 100. Lower scores represent better health (fewer symptoms). Participants were considered a responder if they had a 10 point or more reduction in EORTC QLQ-OV28 AB/GI symptom scale score from baseline.
Time Frame
Baseline and Weeks 8, 9, 16, 18, 24 and 30 (Data Cutoff 14 November 2011)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: female patients, >/=18 years of age epithelial ovarian, fallopian tube or primary peritoneal cancer platinum-resistant disease (disease progression within <6 months of platinum therapy) EOCG performance status of 0-2 Exclusion Criteria: non-epithelial tumours ovarian tumours with low malignant potential previous treatment with >2 chemotherapy regimens prior radiotherapy to the pelvis or abdomen
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
Institut Jules Bordet
City
Bruxelles
ZIP/Postal Code
1000
Country
Belgium
Facility Name
UZ Antwerpen
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Facility Name
UZ Leuven Gasthuisberg
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Clinique Ste-Elisabeth
City
Namur
ZIP/Postal Code
5000
Country
Belgium
Facility Name
University Clinical Centre of the Republic of Srpska
City
Banja Luka
ZIP/Postal Code
78000
Country
Bosnia and Herzegovina
Facility Name
Clinic of Oncology, University Clinical Center Sarajevo
City
Sarajevo
ZIP/Postal Code
7100
Country
Bosnia and Herzegovina
Facility Name
University Clinical Center Tuzla; Clinic for Gynecology and Obstetrition
City
Tuzla
ZIP/Postal Code
75000
Country
Bosnia and Herzegovina
Facility Name
Herlev Hospital; Afdeling for Kræftbehandling
City
Herlev
ZIP/Postal Code
2730
Country
Denmark
Facility Name
Regionshospitalet Herning; Onkologisk afdeling
City
Herning
ZIP/Postal Code
7400
Country
Denmark
Facility Name
Rigshospitalet; Onkologisk Klinik
City
København Ø
ZIP/Postal Code
2100
Country
Denmark
Facility Name
Odense Universitetshospital, Onkologisk Afdeling R
City
Odense C
ZIP/Postal Code
5000
Country
Denmark
Facility Name
Kuopio University Hospital
City
Kuopio
ZIP/Postal Code
70211
Country
Finland
Facility Name
Oulu University Hospital; Gynaecology & Obstetrics Dept
City
Oulu
ZIP/Postal Code
90220
Country
Finland
Facility Name
Clinique Sainte Catherine; Hopital De Semaine
City
Avignon
ZIP/Postal Code
84918
Country
France
Facility Name
Clinique Tivoli; Sce Radiotherapie
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Facility Name
Institut Bergonie; Gynecologie
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
Polyclinique Bordeaux Nord Aquitaine; Chimiotherapie Radiotherapie
City
Bordeaux
ZIP/Postal Code
33077
Country
France
Facility Name
Ch De Brive La Gaillarde; Radiotherapie Oncologie
City
Brive La Gaillarde
ZIP/Postal Code
19312
Country
France
Facility Name
Centre Francois Baclesse; Urologie Gynecologie
City
Caen
ZIP/Postal Code
14076
Country
France
Facility Name
Centre Jean Perrin; Hopital De Jour
City
Clermont Ferrand
ZIP/Postal Code
63011
Country
France
Facility Name
Hopital Louis Pasteur; Medecine B
City
Colmar
ZIP/Postal Code
68024
Country
France
Facility Name
Institut Daniel Hollard; Chimiotherapie Ambulatoire
City
Grenoble
ZIP/Postal Code
38000
Country
France
Facility Name
Centre Hospitalier Departemental Les Oudairies
City
La Roche Sur Yon
ZIP/Postal Code
85925
Country
France
Facility Name
Hopital La Source; Onco Med Hematologie Clinique
City
La Source
ZIP/Postal Code
45100
Country
France
Facility Name
Hopital Andre Mignot; Hematologie - Oncologie
City
Le Chesnay
ZIP/Postal Code
78157
Country
France
Facility Name
Centre Jean Bernard
City
Le Mans
ZIP/Postal Code
72015
Country
France
Facility Name
Centre Oscar Lambret; Cancerologie Gynecologique
City
Lille
ZIP/Postal Code
59020
Country
France
Facility Name
Clin Mut De Lyon Eugene Andre; Medecine 3 A
City
Lyon
ZIP/Postal Code
69424
Country
France
Facility Name
Hopital Layne; Medecine Ambulatoire
City
Mont-de-marsan
ZIP/Postal Code
40024
Country
France
Facility Name
Centre Val Aurelle Paul Lamarque; Medecine A1 A2
City
Montpellier
ZIP/Postal Code
34298
Country
France
Facility Name
Polyclinique Gentilly; CHIMIOTHERAPIE AMBULATOIRE
City
Nancy
ZIP/Postal Code
54100
Country
France
Facility Name
Centre Catherine de Sienne; Chimiotherapie
City
Nantes
ZIP/Postal Code
44202
Country
France
Facility Name
Centre Antoine Lacassagne; Hopital De Jour A2
City
Nice
ZIP/Postal Code
06189
Country
France
Facility Name
Polyclinique Kenval ; Radiotherapie Oncologie
City
Nimes
ZIP/Postal Code
30900
Country
France
Facility Name
Hotel Dieu; Hematologie- Oncologie
City
Paris
ZIP/Postal Code
75181
Country
France
Facility Name
Institut Curie; Oncologie Medicale
City
Paris
ZIP/Postal Code
75231
Country
France
Facility Name
Hopital Saint Louis ; Service d Oncologie Medicale Fougere 6 (Pr Misset)
City
Paris
ZIP/Postal Code
75475
Country
France
Facility Name
HOPITAL TENON; Cancerologie Medicale
City
Paris
ZIP/Postal Code
75970
Country
France
Facility Name
Clinique Francheville; Radiotherapie
City
Perigueux
ZIP/Postal Code
24000
Country
France
Facility Name
Institut Jean Godinot; Oncologie Medicale
City
Reims CEDEX
ZIP/Postal Code
51056
Country
France
Facility Name
Centre Henri Becquerel; Oncologie Medicale
City
Rouen
ZIP/Postal Code
76038
Country
France
Facility Name
Clinique Armoricaine Radiologie; Cons Externes
City
Saint Brieuc
ZIP/Postal Code
22015
Country
France
Facility Name
Ico Rene Gauducheau; Oncologie
City
Saint Herblain
ZIP/Postal Code
44805
Country
France
Facility Name
Centre Radiotherapie Etienne Dolet
City
Saint Nazaire
ZIP/Postal Code
44600
Country
France
Facility Name
Centre Rene Huguenin; Medecine B
City
St Cloud
ZIP/Postal Code
92210
Country
France
Facility Name
Hopital Civil; Expl Fonct Systeme Nerveux
City
Strasbourg
ZIP/Postal Code
67091
Country
France
Facility Name
Hopitaux Du Leman Site Thonon; Maternite Gynecologie
City
Thonon Les Bains
ZIP/Postal Code
74203
Country
France
Facility Name
Institut Claudius Regaud; Departement Oncologie Medicale
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
Centre Alexis Vautrin; Oncologie Medicale
City
Vandoeuvre-les-nancy
ZIP/Postal Code
54519
Country
France
Facility Name
HELIOS Klinikum Berlin-Buch; Klinik für Gynäkologie und Geburtshilfe
City
Berlin
ZIP/Postal Code
13125
Country
Germany
Facility Name
Campus Virchow-Klinikum Charité; Centrum 17; Klinik für Gynäkologie
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Evangelischen Krankenhauses Düsseldorf; Frauenklinik
City
Düsseldorf
ZIP/Postal Code
40217
Country
Germany
Facility Name
Uni-Frauenklinik
City
Düsseldorf
ZIP/Postal Code
40225
Country
Germany
Facility Name
Universitätsklinikum Erlangen; Frauenklinik
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Facility Name
Universitätsklinikum Essen; Zentrum Für Frauenheilkunde
City
Essen
ZIP/Postal Code
45122
Country
Germany
Facility Name
Klinikum Essen-Mitte Ev. Huyssens-Stiftung / Knappschafts GmbH; Klinik für Senologie / Brustzentrum
City
Essen
ZIP/Postal Code
45136
Country
Germany
Facility Name
Klinik Johann Wolfgang von Goethe Uni; Klinik für Frauenheilkunde und Geburtshilfe
City
Frankfurt
ZIP/Postal Code
60596
Country
Germany
Facility Name
Kath.Marienkrankenhaus gGmbH Frauenklinik
City
Hamburg
ZIP/Postal Code
22087
Country
Germany
Facility Name
Gynaekologisch-Onkologische Schwerpunktpraxis Prof. Dr. med. Lueck, Dr. Schrader und Dr. Noeding
City
Hannover
ZIP/Postal Code
30177
Country
Germany
Facility Name
Praxisgemeinschaft; Frauenärzte am Bahnhofsplatz
City
Hildesheim
ZIP/Postal Code
31134
Country
Germany
Facility Name
Klinikum Kassel GmbH; Klinik für Frauenheilkunde und Geburtshilfe
City
Kassel
ZIP/Postal Code
34125
Country
Germany
Facility Name
UNI-Klinikum Campus Kiel Klinik für Gynäkologie und Geburtshilfe
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Facility Name
HELIOS Klinikum Krefeld; Klinik für Frauenheilkunde und Geburtshilfe
City
Krefeld
ZIP/Postal Code
47805
Country
Germany
Facility Name
Universitätsklinikum Schleswig-Holstein / Campus Lübeck; Klinik für Frauenheilkunde und Geburtshilfe
City
Lübeck
ZIP/Postal Code
23538
Country
Germany
Facility Name
Universitätsklinikum Mannheim; Frauenklinik
City
Mannheim
ZIP/Postal Code
68167
Country
Germany
Facility Name
Klinikum der Universität München; Campus Großhadern; Klinik und Poliklinik für Frauenheilkunde
City
Muenchen
ZIP/Postal Code
81377
Country
Germany
Facility Name
Klinikum Nord Frauenklinik
City
Nürnberg
ZIP/Postal Code
90419
Country
Germany
Facility Name
Sana Klinikum Offenbach GmbH; Klinik für Gynäkologie & Geburtshilfe
City
Offenbach
ZIP/Postal Code
63069
Country
Germany
Facility Name
Oncologianova GmbH
City
Recklinghausen
ZIP/Postal Code
45659
Country
Germany
Facility Name
Universitätsfrauen- und Poliklinik am Klinikum Suedstadt
City
Rostock
ZIP/Postal Code
18059
Country
Germany
Facility Name
Städtisches Klinikum Solingen; Klinik für Frauenheilkunde und Geburtshilfe
City
Solingen
ZIP/Postal Code
42653
Country
Germany
Facility Name
Robert-Bosch-Krankenhaus; Interdisziplinäres Zentrum; Tumorzentrum
City
Stuttgart
ZIP/Postal Code
70376
Country
Germany
Facility Name
Universitätsklinik Tübingen; Frauenklinik & Poliklinik
City
Tübingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Universitätsklinikum Ulm Am Michelsberg; Frauenklinik
City
Ulm
ZIP/Postal Code
89075
Country
Germany
Facility Name
Dr. Horst-Schmidt-Kliniken; Frauenheilkunde & Geburtshilfe
City
Wiesbaden
ZIP/Postal Code
65199
Country
Germany
Facility Name
University Hospital of Alexandra
City
Athens
ZIP/Postal Code
11528
Country
Greece
Facility Name
Irccs Centro Di Riferimento Oncologico (CRO); Dipartimento Di Oncologia Medica
City
Aviano
State/Province
Friuli-Venezia Giulia
ZIP/Postal Code
33081
Country
Italy
Facility Name
A.O. Universitaria S. Maria Della Misericordia Di Udine; Oncologia
City
Udine
State/Province
Friuli-Venezia Giulia
ZIP/Postal Code
33100
Country
Italy
Facility Name
AZIENDA POLICLINICO UMBERTO I; Ginecologia ed Ostetricia
City
Roma
State/Province
Lazio
ZIP/Postal Code
00161
Country
Italy
Facility Name
Istituto Regina Elena; Oncologia Medica A
City
Roma
State/Province
Lazio
ZIP/Postal Code
00168
Country
Italy
Facility Name
Ospedale S.G.Calibita Fatebenefratelli; Unità Operativa Oncologia
City
Roma
State/Province
Lazio
ZIP/Postal Code
00186
Country
Italy
Facility Name
Ospedali Riuniti; Divisione Ostetricia e Ginecologia
City
Bergamo
State/Province
Lombardia
ZIP/Postal Code
24128
Country
Italy
Facility Name
Az. Osp. Carlo Poma; Divisione Di Oncologia Medica
City
Mantova
State/Province
Lombardia
ZIP/Postal Code
46100
Country
Italy
Facility Name
Istituto Nazionale dei Tumori; Divisione Oncologia Chirurgica e Ginecologica
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20133
Country
Italy
Facility Name
Meander Mc, Locatie Lichtenberg; Dept of Lung Diseases
City
Amersfoort
ZIP/Postal Code
3818 ES
Country
Netherlands
Facility Name
Leyenburg Ziekenhuis; Internal Medecine
City
Den Haag
ZIP/Postal Code
2545 CH
Country
Netherlands
Facility Name
Catharina ZKHS; Inwendige Geneeskunde Afd.
City
Eindhoven
ZIP/Postal Code
5623 EJ
Country
Netherlands
Facility Name
Martini Ziekenhuis; Dept of Internal Medicine
City
Groningen
ZIP/Postal Code
9728 NT
Country
Netherlands
Facility Name
Stichting St. Antonius Ziekenhuis
City
Nieuwegein
ZIP/Postal Code
3430 EM
Country
Netherlands
Facility Name
Universitair Medisch Centrum Utrecht; Inwendige Geneeskunde Afd.
City
Utrecht
ZIP/Postal Code
3584 CX
Country
Netherlands
Facility Name
The Norvegian Radium Hospital Montebello; Dept of Oncology
City
Oslo
ZIP/Postal Code
0379
Country
Norway
Facility Name
St. Olavs Hospital; Kvinneklinikken
City
Trondheim
ZIP/Postal Code
7006
Country
Norway
Facility Name
IPO de Lisboa; Servico de Oncologia Medica
City
Lisboa
ZIP/Postal Code
1099-023
Country
Portugal
Facility Name
IPO do Porto; Servico de Oncologia Medica
City
Porto
ZIP/Postal Code
4200-072
Country
Portugal
Facility Name
Corporacio Sanitaria Parc Tauli; Servicio de Oncologia
City
Sabadell
State/Province
Barcelona
ZIP/Postal Code
8208
Country
Spain
Facility Name
Hospital Universitario Marques de Valdecilla; Servicio de Oncologia
City
Santander
State/Province
Cantabria
ZIP/Postal Code
39008
Country
Spain
Facility Name
Hospital Universitario Reina Sofia; Servicio de Oncologia
City
Córdoba
State/Province
Cordoba
ZIP/Postal Code
14004
Country
Spain
Facility Name
Hospital Son Llatzer; Servicio de Oncologia
City
Palma de Mallorca
State/Province
Islas Baleares
ZIP/Postal Code
07198
Country
Spain
Facility Name
Hospital Univ Vall d'Hebron; Servicio de Oncologia
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
Facility Name
Hospital de Terrassa; Servicio de Oncologia
City
Barcelona
ZIP/Postal Code
08227
Country
Spain
Facility Name
Hospital Universitari Arnau de Vilanova de Lleida; Servicio de Oncologia
City
Lerida
ZIP/Postal Code
25198
Country
Spain
Facility Name
Hospital General Universitario Gregorio Marañon; Servicio de Oncologia
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Centro Oncologico MD Anderson Internacional; Servicio de Oncologia
City
Madrid
ZIP/Postal Code
28033
Country
Spain
Facility Name
Centro Integral Oncologico Clara Campal (CIOCC); Dirección Médica
City
Madrid
ZIP/Postal Code
28050
Country
Spain
Facility Name
Hospital General Universitario J.M Morales Meseguer; Servicio de Oncologia
City
Murcia
ZIP/Postal Code
30008
Country
Spain
Facility Name
Instituto Valenciano Oncologia; Oncologia Medica
City
Valencia
ZIP/Postal Code
46009
Country
Spain
Facility Name
Hospital Universitario la Fe; Servicio de Oncologia
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Hospital Universitario Miguel Servet; Servicio Oncologia
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Facility Name
Uni Hospital Linkoeping; Dept. of Oncology
City
Linköping
ZIP/Postal Code
58185
Country
Sweden
Facility Name
Norrlands Uni Hospital; Onkologi Avd.
City
Umeå
ZIP/Postal Code
901 85
Country
Sweden
Facility Name
Akademiska sjukhuset, Onkologkliniken
City
Uppsala
ZIP/Postal Code
751 85
Country
Sweden
Facility Name
Örebro University Hospital; Department of Gynecologic Oncology
City
Örebro
ZIP/Postal Code
70185
Country
Sweden
Facility Name
Adana Baskent University Hospital; Medical Oncology
City
Adana
ZIP/Postal Code
01120
Country
Turkey
Facility Name
Ankara Baskent University Medicine Faculty; Gynaecology
City
Ankara
ZIP/Postal Code
06500
Country
Turkey
Facility Name
Istanbul Uni Cerrahpasa Medical Faculty Hospital; Medical Oncology
City
Istanbul
ZIP/Postal Code
34300
Country
Turkey
Facility Name
Anadolu Health Center; Medical Oncology
City
Kocaeli
ZIP/Postal Code
41400
Country
Turkey

12. IPD Sharing Statement

Citations:
PubMed Identifier
28595285
Citation
Roncolato FT, Gibbs E, Lee CK, Asher R, Davies LC, Gebski VJ, Friedlander M, Hilpert F, Wenzel L, Stockler MR, King M, Pujade-Lauraine E. Quality of life predicts overall survival in women with platinum-resistant ovarian cancer: an AURELIA substudy. Ann Oncol. 2017 Aug 1;28(8):1849-1855. doi: 10.1093/annonc/mdx229.
Results Reference
derived
PubMed Identifier
28481967
Citation
Bamias A, Gibbs E, Khoon Lee C, Davies L, Dimopoulos M, Zagouri F, Veillard AS, Kosse J, Santaballa A, Mirza MR, Tabaro G, Vergote I, Bloemendal H, Lykka M, Floquet A, Gebski V, Pujade-Lauraine E. Bevacizumab with or after chemotherapy for platinum-resistant recurrent ovarian cancer: exploratory analyses of the AURELIA trial. Ann Oncol. 2017 Aug 1;28(8):1842-1848. doi: 10.1093/annonc/mdx228.
Results Reference
derived
PubMed Identifier
27871723
Citation
Sorio R, Roemer-Becuwe C, Hilpert F, Gibbs E, Garcia Y, Kaern J, Huizing M, Witteveen P, Zagouri F, Coeffic D, Luck HJ, Gonzalez-Martin A, Kristensen G, Levache CB, Lee CK, Gebski V, Pujade-Lauraine E; AURELIA Investigators. Safety and efficacy of single-agent bevacizumab-containing therapy in elderly patients with platinum-resistant recurrent ovarian cancer: Subgroup analysis of the randomised phase III AURELIA trial. Gynecol Oncol. 2017 Jan;144(1):65-71. doi: 10.1016/j.ygyno.2016.11.006. Epub 2016 Nov 18.
Results Reference
derived
PubMed Identifier
24687829
Citation
Stockler MR, Hilpert F, Friedlander M, King MT, Wenzel L, Lee CK, Joly F, de Gregorio N, Arranz JA, Mirza MR, Sorio R, Freudensprung U, Sneller V, Hales G, Pujade-Lauraine E. Patient-reported outcome results from the open-label phase III AURELIA trial evaluating bevacizumab-containing therapy for platinum-resistant ovarian cancer. J Clin Oncol. 2014 May 1;32(13):1309-16. doi: 10.1200/JCO.2013.51.4240. Epub 2014 Mar 31.
Results Reference
derived
PubMed Identifier
24637997
Citation
Pujade-Lauraine E, Hilpert F, Weber B, Reuss A, Poveda A, Kristensen G, Sorio R, Vergote I, Witteveen P, Bamias A, Pereira D, Wimberger P, Oaknin A, Mirza MR, Follana P, Bollag D, Ray-Coquard I. Bevacizumab combined with chemotherapy for platinum-resistant recurrent ovarian cancer: The AURELIA open-label randomized phase III trial. J Clin Oncol. 2014 May 1;32(13):1302-8. doi: 10.1200/JCO.2013.51.4489. Epub 2014 Mar 17. Erratum In: J Clin Oncol. 2014 Dec 10;32(35):4025.
Results Reference
derived

Learn more about this trial

AURELIA: A Study of Avastin (Bevacizumab) Added to Chemotherapy in Patients With Platinum-resistant Ovarian Cancer

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