Phase 3
N=361
AURELIA: A Study of Avastin (Bevacizumab) Added to Chemotherapy in Patients With Platinum-resistant Ovarian Cancer
Ovarian Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00976911 ↗Enrolled (actual)
361
Serious AEs
29.2%
Results posted
Feb 2015
Primary outcome: Primary: Percentage of Participants With Disease Progression or Death (Data Cutoff 14 November 2011) — 92.3; 78.8 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Bevacizumab (Drug); liposomal doxorubicin (Drug); paclitaxel (Drug); topotecan (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Hoffmann-La Roche
- Primary completion
- Jul 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Disease Progression or Death (Data Cutoff 14 November 2011) |
92.3; 78.8 | — |
| PRIMARY Progression Free Survival (PFS; Data Cutoff 14 November 2011) |
3.4; 6.8 | <0.0001 sig |
| 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) |
12.5; 28.2 | 0.0010 sig |
| SECONDARY Duration of Objective Response (Data Cutoff 14 November 2011) |
5.4; 9.4 | 0.0202 sig |
| SECONDARY Percentage of Participants Who Died (Data Cutoff 25 January 2013) |
75.8; 71.5 | — |
| SECONDARY Overall Survival (Data Cutoff 25 January 2013) |
13.3; 16.6 | 0.1360 |
| 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) |
19.0; 27.9; 23.3; 26.7; 22.7; 32.1 | 0.1859 |
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.
Eligibility Criteria
Inclusion Criteria
- female patients, >/=18 years of age
- epithelial ovarian, fallopian tube or primary peritoneal cancer
- platinum-resistant disease (disease progression within 2 chemotherapy regimens
- prior radiotherapy to the pelvis or abdomen
Data sourced from ClinicalTrials.gov (NCT00976911). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.