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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

3 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-03-31

Study Completion Date

2013-09-30

Brief Summary

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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

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Conditions

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Ovarian Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cohort

No interventions assigned to this group

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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San Salvador, , El Salvador

Site Status

Countries

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El Salvador

Other Identifiers

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ML28428

Identifier Type: -

Identifier Source: org_study_id