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 currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01697488
First received: September 28, 2012
Last updated: July 7, 2014
Last verified: July 2014
  Purpose

This observational study will evaluate the safety, efficacy, quality of life and predictive/selection factors for Avastin (bevacizumab) in combination with carb oplatin/paclitaxel in first line in patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer in clinical practice. Data of eligib le patients will be collected during up to 15 months of treatment and 12 months of follow-up.


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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Efficacy: Progression-free survival [ Time Frame: up to approximately 27 months ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: approximately 5 years ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • Selection criteria for first-line treatment with Avastin and carboplatin/paclitaxel: clinical/demographic patient characteristics [ Time Frame: approximately 5 years ] [ Designated as safety issue: No ]
  • Treatment discontinuations/modifications [ Time Frame: approximately 5 years ] [ Designated as safety issue: No ]
  • Treatment duration [ Time Frame: approximately 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 800
Study Start Date: February 2012
Estimated Study Completion Date: May 2017
Estimated Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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

Criteria

Inclusion Criteria:

  • Adult patients, >/= 18 years of age
  • 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

Contacts
Contact: Reference Study ID Number: ML27765 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com

Locations
Germany
Recruiting
Offenburg, Germany, 77652
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: NCT01697488     History of Changes
Other Study ID Numbers: ML27765
Study First Received: September 28, 2012
Last Updated: July 7, 2014
Health Authority: Germany: Paul-Ehrlich-Institut

Additional relevant MeSH terms:
Neoplasms
Peritoneal Neoplasms
Abdominal Neoplasms
Neoplasms by Site
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Bevacizumab
Carboplatin
Paclitaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors

ClinicalTrials.gov processed this record on July 23, 2014