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

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ClinicalTrials.gov Identifier: NCT00976911
Recruitment Status : Completed
First Posted : September 15, 2009
Results First Posted : February 25, 2015
Last Update Posted : February 25, 2015
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Tracking Information
First Submitted Date  ICMJE September 14, 2009
First Posted Date  ICMJE September 15, 2009
Results First Submitted Date  ICMJE December 3, 2014
Results First Posted Date  ICMJE February 25, 2015
Last Update Posted Date February 25, 2015
Study Start Date  ICMJE October 2009
Actual Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 24, 2015)
  • Percentage of Participants With Disease Progression or Death (Data Cutoff 14 November 2011) [ 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 ]
    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) [ 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 ]
    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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 14, 2009)
Progression-free survival [ Time Frame: tumour assessments every 8-9 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 24, 2015)
  • 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) [ 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 ]
    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) [ 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 ]
    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) [ 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 ]
  • Overall Survival (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 ]
    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) [ Time Frame: Baseline and Weeks 8, 9, 16, 18, 24 and 30 (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.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 14, 2009)
  • Objective response rate, biological progression-free interval, overall survival [ Time Frame: tumour assessments every 8-9 weeks ]
  • Quality of life: EORTC, HADS, FOSI [ Time Frame: weeks 8, 16 and 24 or 9, 18 and 27 ]
  • Safety and tolerability: AEs, laboratory parameters, ECOG performance status, vital signs [ Time Frame: throughout study, laboratory and ECOG assessments every 2-3 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE AURELIA: A Study of Avastin (Bevacizumab) Added to Chemotherapy in Patients With Platinum-resistant Ovarian Cancer
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Ovarian Cancer
Intervention  ICMJE
  • Drug: bevacizumab [Avastin]
    10m/kg iv every 2 weeks or 15mg/kg iv every 3 weeks
  • Drug: liposomal doxorubicin
    40mg/m2 iv every 4 weeks
  • Drug: paclitaxel
    80mg/m2 iv on days 1, 8, 15 and 22 of each 4-week cycle
  • Drug: topotecan
    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
Study Arms  ICMJE
  • Active Comparator: 1
    Interventions:
    • Drug: liposomal doxorubicin
    • Drug: paclitaxel
    • Drug: topotecan
  • Experimental: 2
    Interventions:
    • Drug: bevacizumab [Avastin]
    • Drug: liposomal doxorubicin
    • Drug: paclitaxel
    • Drug: topotecan
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 19, 2014)
361
Original Estimated Enrollment  ICMJE
 (submitted: September 14, 2009)
300
Actual Study Completion Date  ICMJE July 2014
Actual Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Bosnia and Herzegovina,   Denmark,   Finland,   France,   Germany,   Greece,   Italy,   Netherlands,   Norway,   Portugal,   Spain,   Sweden,   Turkey
Removed Location Countries Australia,   Poland
 
Administrative Information
NCT Number  ICMJE NCT00976911
Other Study ID Numbers  ICMJE MO22224
2009-011400-33
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hoffmann-La Roche
Study Sponsor  ICMJE Hoffmann-La Roche
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Trials Hoffmann-La Roche
PRS Account Hoffmann-La Roche
Verification Date February 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP