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

This study is currently recruiting participants.
Verified May 2013 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00976911
First received: September 14, 2009
Last updated: May 7, 2013
Last verified: May 2013
History of Changes
  Purpose

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 (10mg/kg iv 2-weekly or 15mg/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 (15mg/kg iv 3-weekly). Target sample size is 100-500 individuals.


Condition Intervention Phase
Ovarian Cancer
 Drug: bevacizumab [Avastin]
Drug: paclitaxel
Drug: topotecan
Drug: liposomal doxorubicin
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Progression-free survival [ Time Frame: tumour assessments every 8-9 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Objective response rate, biological progression-free interval, overall survival [ Time Frame: tumour assessments every 8-9 weeks ] [ Designated as safety issue: No ]
  • Quality of life: EORTC, HADS, FOSI [ Time Frame: weeks 8, 16 and 24 or 9, 18 and 27 ] [ Designated as safety issue: No ]
  • Safety and tolerability: AEs, laboratory parameters, ECOG performance status, vital signs [ Time Frame: throughout study, laboratory and ECOG assessments every 2-3 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: October 2009
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 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
Drug: liposomal doxorubicin
40mg/m2 iv every 4 weeks
Experimental: 2 Drug: bevacizumab [Avastin]
10m/kg iv every 2 weeks or 15mg/kg iv every 3 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
Drug: liposomal doxorubicin
40mg/m2 iv every 4 weeks

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00976911

Contacts
Contact: Please reference Study ID Number: MO22224 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) genentechclinicaltrials@druginfo.com

  Show 119 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00976911     History of Changes
Other Study ID Numbers: MO22224, 2009-011400-33
Study First Received: September 14, 2009
Last Updated: May 7, 2013
Health Authority: Spain: Ministry of Health

Additional relevant MeSH terms:
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Doxorubicin
Bevacizumab
Paclitaxel
Topotecan
 Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances

ClinicalTrials.gov processed this record on June 18, 2013