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

Roche

Status: Completed

Conditions: Ovarian Cancer

Study type: Observational

Funder types: Industry

Identifiers

NCT02151370

ML28428

Details and patient eligibility

About

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.

Enrollment: 3 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

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.

Trial design

3 participants in 1 patient group

Cohort