An Observational Study of Avastin (Bevacizumab) in Patients With Ovarian Cancer

Completed

• Conditions: Ovarian Cancer

• Registration Number: NCT02151370
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

This observational study will collect data about safety in female patients with advanced ovarian epithelial cancer with measurable residual disease after surger y. The treating physician has decided to treat the patients with Avastin (bevaci zumab) in combination with chemotherapy followed by Avastin monotherapy accordin g to the local label. Data will be collected for 72 weeks.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03
• Primary Completion: 2013-09
• Study Completion: 2013-09
• Status Verified: 2014-05
• Study First Submitted: 2014-05-28
• Study First Submitted QC: 2014-05-28
• Last Update Submitted: 2014-05-28
• Study First Posted: 2014-05-30
• Last Update Posted: 2014-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 3

Inclusion Criteria

• Female patients over 18 years of age
• Histologically confirmed Advanced Epithelial Ovarian Cancer
• Confirmed ascites prior to surgery
• Residual disease after surgery
• Patients are chemotherapy naïve or have received only one prior line of treatment for their disease
• International Federation of Gynecology and Obstetrics (FIGO) stage IIIb or IV disease
• Eastern Cooperative Oncology Group (ECOG) performance status <=2
• Patients must meet treatment eligibility requirements according to treating physician and Summary of Product Characteristics (SmPC) criteria for Avastin plus chemotherapy.

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Exclusion Criteria

• Pregnancy or lactation
• Low grade tumors, since this does not necessarily requires systemic treatment. Complete surgical resection
• Uncontrollable hypertension
• Unexplained bleeding
• Known hypersensitivity to any components of bevacizumab
• All contraindications specified in the respective Summary of Product Characteristics (SmPC) and/or local labelling of Avastin and the corresponding chemotherapy must be adhered to by the physician.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The proportion of patients who require paracenthesis during treatment with Avastin	72 weeks
The amount of ascitic fluid extracted during treatment with Avastin	72 weeks

Secondary Outcome Measures

Name	Time	Method
Safety: Incidence of adverse events	72 weeks
To evaluate Eastern Cooperative Oncology Group (ECOG) performance status before and after start of therapy	72 weeks
To determine regional epidemiologic data for the studied population	72 weeks