An Observational Study of Avastin (Bevacizumab) in Patients With Ovarian Cancer
Ascites Control Treating Ovarian Cancer With Bevacizumab: "ACT-OB"
1 other identifier
observational
3
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Mar 2013
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2013
CompletedFirst Submitted
Initial submission to the registry
May 28, 2014
CompletedFirst Posted
Study publicly available on registry
May 30, 2014
CompletedMay 30, 2014
May 1, 2014
6 months
May 28, 2014
May 28, 2014
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (3)
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
Study Arms (1)
Cohort
Eligibility Criteria
Female patients with Advanced FIGO Stage (IIIb to IV) Ovarian Epithelial Cancer with measurable residual disease after surgery
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Unknown Facility
San Salvador, 01101, El Salvador
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 28, 2014
First Posted
May 30, 2014
Study Start
March 1, 2013
Primary Completion
September 1, 2013
Study Completion
September 1, 2013
Last Updated
May 30, 2014
Record last verified: 2014-05