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

NCT00976911 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 361

Last updated 2022-06-21

Study results available
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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.

Conditions

Interventions

DRUG

Bevacizumab

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

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-10-29
Primary Completion
2014-07-09
Completion
2014-07-09

Countries

  • Belgium
  • Bosnia and Herzegovina
  • Denmark
  • Finland
  • France
  • Germany
  • Greece
  • Italy
  • Netherlands
  • Norway
  • Portugal
  • Spain
  • Sweden
  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00976911 on ClinicalTrials.gov