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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)

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ClinicalTrials.gov Identifier: NCT01697488
Recruitment Status : Active, not recruiting
First Posted : October 2, 2012
Last Update Posted : February 1, 2018
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease
Peritoneal Neoplasms

Study Design
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Study Type : Observational
Actual Enrollment : 1090 participants
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
Actual Study Start Date : February 2, 2012
Estimated Primary Completion Date : March 31, 2019
Estimated Study Completion Date : March 31, 2019
Groups and Cohorts
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Group/Cohort
Cohort
Overall sample
Subgroup
Patients aged >/= 70 years


Outcome Measures
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Primary Outcome Measures :
  1. Efficacy: Progression-free survival [ Time Frame: up to approximately 27 months ]
  2. Safety: Incidence of adverse events [ Time Frame: approximately 5 years ]

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

Eligibility Criteria
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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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01697488     History of Changes
Other Study ID Numbers: ML27765
First Posted: October 2, 2012    Key Record Dates
Last Update Posted: February 1, 2018
Last Verified: January 2018

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