An Observational Study of Avastin (Bevacizumab) in Combination With Carboplatin/Paclitaxel in First Line in Patients With Advanced Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer (OTILIA)

Completed

• Conditions: Peritoneal Neoplasms

• Registration Number: NCT01697488
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

This observational study will evaluate the safety, efficacy, quality of life and predictive/selection factors for Avastin (bevacizumab) in combination with carboplatin/paclitaxel in first line in patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer in clinical practice. Data of eligible patients will be collected during up to 15 months of treatment and 12 months of follow-up. A second recruitment phase has been opened to focus on patients \>/= 70 years.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02-02
• Study First Submitted: 2012-09-28
• Study First Submitted QC: 2012-09-28
• Study First Posted: 2012-10-02
• Primary Completion: 2019-09-27
• Study Completion: 2019-09-27
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-07
• Last Update Posted: 2019-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1090

Inclusion Criteria

• Study phase 1: Patients aged >/= 18 years
• Study phase 2: Patients aged >/= 70 years
• Newly diagnosed advanced epithelial ovarian cancer, fallopian tube carcinoma or primary peritoneal cancer with indication for a first-line carboplatin/paclitaxel chemotherapy in combination with Avastin

Exclusion Criteria

• Contraindications to Avastin according to Summary of Product Characteristics

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Efficacy: Progression-free survival	up to approximately 27 months
Safety: Incidence of adverse events	approximately 5 years

Secondary Outcome Measures

Name	Time	Method
Quality of life: European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30/QLQ-OV28 questionnaires	up to approximately 27 months
Selection criteria for first-line treatment with Avastin and carboplatin/paclitaxel: clinical/demographic patient characteristics	approximately 5 years
Treatment duration	approximately 5 years
Treatment discontinuations/modifications	approximately 5 years

Trial Locations

Locations (1)

Ortenau Klinikum Offenburg; Med. Klinik II; Mammachirurgie und Gynäkologisch-Onkologische Chirurgie; 🇩🇪 Offenburg, Germany