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NCT Number: NCT02151370

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

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.

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Key information

Conditions

Ovarian Cancer Adnexal Diseases Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Site Ovarian Diseases Ovarian Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

San Salvador, 01101, El Salvador

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. The proportion of patients who require paracenthesis during treatment with Avastin

    Time frame: 72 weeks

  2. The amount of ascitic fluid extracted during treatment with Avastin

    Time frame: 72 weeks

Secondary outcomes

  1. Safety: Incidence of adverse events

    Time frame: 72 weeks

  2. To evaluate Eastern Cooperative Oncology Group (ECOG) performance status before and after start of therapy

    Time frame: 72 weeks

  3. To determine regional epidemiologic data for the studied population

    Time frame: 72 weeks

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
May 30, 2014
Registry last updated
May 30, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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