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)

Peritoneal Neoplasms Clinical Trial

Official title:

Non-interventional Surveillance Study (NIS) on First-line (FL) Bevacizumab (Avastin) in Combination With Carboplatin/Paclitaxel in Patients With Advanced Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01697488
• Other study ID #: ML27765
• Status: Completed
• Start date: February 2, 2012
• Est. completion date: September 27, 2019

Study information

• Verified date: October 2019
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1090
• Est. completion date: September 27, 2019
• Est. primary completion date: September 27, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Peritoneal Neoplasms

Locations

Country	Name	City	State
Germany	Ortenau Klinikum Offenburg; Med. Klinik II; Mammachirurgie und Gynäkologisch-Onkologische Chirurgie	Offenburg

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy: Progression-free survival		up to approximately 27 months
Primary	Safety: Incidence of adverse events		approximately 5 years
Secondary	Quality of life: European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30/QLQ-OV28 questionnaires		up to approximately 27 months
Secondary	Selection criteria for first-line treatment with Avastin and carboplatin/paclitaxel: clinical/demographic patient characteristics		approximately 5 years
Secondary	Treatment discontinuations/modifications		approximately 5 years
Secondary	Treatment duration		approximately 5 years