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

Ascites Control Treating Ovarian Cancer With Bevacizumab: ACT-OB

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02151370

Enrollment

Registered

2014-05-30

Start date

2013-03-31

Completion date

2013-09-30

Last updated

2014-05-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ovarian Cancer

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

El Salvador

Outcome results