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

Ovarian Cancer Clinical Trial

Official title:

Ascites Control Treating Ovarian Cancer With Bevacizumab: "ACT-OB"

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02151370
• Other study ID #: ML28428
• Status: Completed
• Phase: N/A
• First received: May 28, 2014
• Last updated: May 28, 2014
• Start date: March 2013
• Est. completion date: September 2013

Study information

• Verified date: May 2014
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: El Salvador: Ministry of Health
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Ovarian Cancer
• Ovarian Neoplasms

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

El Salvador, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The proportion of patients who require paracenthesis during treatment with Avastin		72 weeks	No
Primary	The amount of ascitic fluid extracted during treatment with Avastin		72 weeks	No
Secondary	Safety: Incidence of adverse events		72 weeks	No
Secondary	To evaluate Eastern Cooperative Oncology Group (ECOG) performance status before and after start of therapy		72 weeks	No
Secondary	To determine regional epidemiologic data for the studied population		72 weeks	No