Trial · NCT00976911
AURELIA: A Study of Avastin (Bevacizumab) Added to Chemotherapy in Patients With Platinum-resistant Ovarian Cancer
NCT00976911, Phase 3, Completed, Hoffmann-La Roche; results first posted 2015-02-25
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. AURELIA: A Study of Avastin (Bevacizumab) Added to Chemotherapy in Patients With Platinum-resistant Ovarian Cancer. Trials, record NCT00976911. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00976911
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- AURELIA: A Study of Avastin (Bevacizumab) Added to Chemotherapy in Patients With Platinum-resistant Ovarian Cancer
- NCT number
- NCT00976911
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 361 participants, actual
- Lead sponsor
- Hoffmann-La Roche
- Conditions
- Ovarian Cancer
- Interventions
- Bevacizumab, liposomal doxorubicin, paclitaxel, topotecan
- First posted
- 2009-09-15
- Last updated
- 2022-06-21
- Other registries' IDs
- eudract:2009-011400-33
- Results first posted
- 2015-02-25
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Disease Progression or Death (Data Cutoff 14 November 2011) | 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. |
| Primary | Progression Free Survival (PFS; Data Cutoff 14 November 2011) | 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. |
| Secondary | 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) | 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. |
| Secondary | Duration of Objective Response (Data Cutoff 14 November 2011) | 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. |
| Secondary | Percentage of Participants Who Died (Data Cutoff 25 January 2013) | 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 | |
| Secondary | Overall Survival (Data Cutoff 25 January 2013) | 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. |
| Secondary | 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) | 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. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Disease Progression or Death (Data Cutoff 14 November 2011) | 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 | ITT Population: All participants randomized to study treatment, irrespective of whether or not the assigned treatment was actually received. For all efficacy analyses, participants were grouped according to the treatment assigned at randomization | percentage of participants | NUMBER |
| SECONDARY | 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) | 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 | ITT Population; only participants with measurable disease at baseline were included in the analysis. | percentage of participants | NUMBER |
| SECONDARY | Duration of Objective Response (Data Cutoff 14 November 2011) | 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 | ITT Population; only participants with a best overall confirmed response of CR or PR were included in the analysis. | months | MEDIAN |
| SECONDARY | Percentage of Participants Who Died (Data Cutoff 25 January 2013) | 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 | ITT Population | percentage of participants | NUMBER |
| PRIMARY | Progression Free Survival (PFS; Data Cutoff 14 November 2011) | 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 | ITT Population; only participants with an event of progression or death were included in the analysis | months | MEDIAN |
| SECONDARY | Overall Survival (Data Cutoff 25 January 2013) | 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 | ITT Population; only participants who died were included in the analysis. | months | MEDIAN |
| SECONDARY | 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) | Baseline and Weeks 8, 9, 16, 18, 24 and 30 (Data Cutoff 14 November 2011) | ITT population; n (number) = (equals) number of participants that completed the questionnaire at baseline and at the specified visit. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group20
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Disease Progression or Death (Data Cutoff 14 November 2011) | Chemotherapy | 92.3 | percentage of participants | ||
| Percentage of Participants With Disease Progression or Death (Data Cutoff 14 November 2011) | Chemotherapy + Bevacizumab | 78.8 | percentage of participants | ||
| 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) | Chemotherapy | 12.5 | 95% Confidence Interval 7.1 to 17.9 | percentage of participants | |
| 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) | Chemotherapy + Bevacizumab | 28.2 | 95% Confidence Interval 20.8 to 35.6 | percentage of participants | |
| Duration of Objective Response (Data Cutoff 14 November 2011) | Chemotherapy | 5.4 | 95% Confidence Interval 3.81 to 9.23 | months | |
| Duration of Objective Response (Data Cutoff 14 November 2011) | Chemotherapy + Bevacizumab | 9.4 | 95% Confidence Interval 6.60 to 11.63 | months | |
| Percentage of Participants Who Died (Data Cutoff 25 January 2013) | Chemotherapy | 75.8 | percentage of participants | ||
| Percentage of Participants Who Died (Data Cutoff 25 January 2013) | Chemotherapy + Bevacizumab | 71.5 | percentage of participants | ||
| Progression Free Survival (PFS; Data Cutoff 14 November 2011) | Chemotherapy | 3.4 | 95% Confidence Interval 2.10 to 3.75 | months | |
| Progression Free Survival (PFS; Data Cutoff 14 November 2011) | Chemotherapy + Bevacizumab | 6.8 | 95% Confidence Interval 5.62 to 7.79 | months |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Chemotherapy | 182 | |
| Overall Study | STARTED | Chemotherapy + Bevacizumab | 179 | |
| Overall Study | COMPLETED | Chemotherapy | 0 | |
| Overall Study | COMPLETED | Chemotherapy + Bevacizumab | 0 | |
| Overall Study | NOT COMPLETED | Chemotherapy | 182 | |
| Overall Study | NOT COMPLETED | Chemotherapy + Bevacizumab | 179 |
Source ClinicalTrials.gov
Adverse events206
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Chemotherapy | 46 | 181 | |
| other | Anaemia | Blood and lymphatic system disorders | Chemotherapy + Bevacizumab | 35 | 179 | |
| other | Leukopenia | Blood and lymphatic system disorders | Chemotherapy | 25 | 181 | |
| other | Leukopenia | Blood and lymphatic system disorders | Chemotherapy + Bevacizumab | 23 | 179 | |
| other | Neutropenia | Blood and lymphatic system disorders | Chemotherapy | 44 | 181 | |
| other | Neutropenia | Blood and lymphatic system disorders | Chemotherapy + Bevacizumab | 55 | 179 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Chemotherapy | 12 | 181 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Chemotherapy + Bevacizumab | 10 | 179 | |
| other | Abdominal pain | Gastrointestinal disorders | Chemotherapy | 15 | 181 | |
| other | Abdominal pain | Gastrointestinal disorders | Chemotherapy + Bevacizumab | 17 | 179 |
1 to 10 of 206Source ClinicalTrials.gov
See all 206 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Chemotherapy | ||
| Total, all-cause mortality | Chemotherapy + Bevacizumab | ||
| Total, other adverse events | Chemotherapy | 129 | 181 |
| Total, other adverse events | Chemotherapy + Bevacizumab | 146 | 179 |
| Total, serious adverse events | Chemotherapy | 49 | 181 |
| Total, serious adverse events | Chemotherapy + Bevacizumab | 56 | 179 |
Source ClinicalTrials.gov
Papers7
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Chemotherapy vs Chemotherapy + Bevacizumab: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00976911
GET https://conductscience.org/api/trials/v1/NCT00976911/events?page=2