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)

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Hoffmann-La Roche

ClinicalTrials.gov Identifier:

NCT01697488

First received: September 28, 2012

Last updated: July 20, 2017

Last verified: June 2017

History of Changes

Purpose

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.

Condition
Peritoneal Neoplasms


Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
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

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

Efficacy: Progression-free survival [ Time Frame: up to approximately 27 months ]
Safety: Incidence of adverse events [ Time Frame: approximately 5 years ]

Secondary Outcome Measures:

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


Enrollment:	1090
Actual Study Start Date:	February 2, 2012
Estimated Study Completion Date:	March 31, 2019
Estimated Primary Completion Date:	March 31, 2019 (Final data collection date for primary outcome measure)

Groups/Cohorts
Cohort Overall sample
Subgroup Patients aged >/= 70 years

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

Patients with newly diagnosed advanced epithelial ovarian, fallopian tube or primary peritoneal cancer with indication for first-line carboplatin/paclitaxel chemotherapy in combination with Avastin. In the second study phase recruitment focusses on patients >/= 70 years.

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01697488

Locations


Germany
Ortenau Klinikum Offenburg; Med. Klinik II; Mammachirurgie und Gynäkologisch-Onkologische Chirurgie
Offenburg, Germany, 77652

Sponsors and Collaborators

Hoffmann-La Roche

Investigators


Study Director:	Clinical Trials	Hoffmann-La Roche

More Information


Responsible Party:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT01697488 History of Changes
Other Study ID Numbers:	ML27765
Study First Received:	September 28, 2012
Last Updated:	July 20, 2017

Additional relevant MeSH terms:


Peritoneal Neoplasms Abdominal Neoplasms Neoplasms by Site Neoplasms Digestive System Neoplasms Digestive System Diseases Peritoneal Diseases Paclitaxel Bevacizumab Carboplatin Antineoplastic Agents, Phytogenic	Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors

ClinicalTrials.gov processed this record on September 21, 2017

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