A Study to Evaluate Safety and Effectiveness of Bevacizumab in Combination With Paclitaxel and Cisplatin/Carboplatin or Toptecan in Participants With Advanced Cervical Cancer

Last updated: March 15, 2018
Sponsor: Hoffmann-La Roche
Overall Status: Completed

Phase

N/A

Condition

Cervical Cancer

Vaginal Cancer

Dysfunctional Uterine Bleeding

Treatment

N/A

Clinical Study ID

NCT03071848
ML39360
  • Ages > 18
  • Female

Study Summary

This study will evaluate the safety of bevacizumab (Avastin®) combined with standard chemotherapy in participant with advanced cervical cancer, with special focus on the incidence of gastrointestinal (GI) and genitourinary (GU) fistulas and GI perforations in the common practice setting.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age 18 or older

  • Diagnosis of primary stage IVB, recurrent or persistent squamous cell carcinoma,adenosquamous carcinoma, or adenocarcinoma of the cervix which is not amenable tocurative treatment with surgery and/or radiation therapy

  • Retrospective clinical decision made to initiate therapy with bevacizumab (Avastin®)combined with standard chemotherapy (cisplatin or carboplatin or topotecan andpaclitaxel) between 01 January 2015 and 01 January 2016

  • All participants must have received at least one dose of bevacizumab combined withstandard chemotherapy between 01 January 2015 and 01 January 2016 AND have at least 12months of documented follow up, from treatment start, unless died or lost to follow upwithin the minimum study entry follow up period

  • Availability of documentation of for advanced cervical cancer (including priortreatment as applicable) and follow up in the participant's medical records

Exclusion

Exclusion Criteria:

  • Participation during the study period in an interventional clinical trial or any otherinterventional study that may impact advanced cervical cancer outcome

  • Participants who have received prior therapy with any anti-VEGF drug, includingbevacizumab

Study Design

Total Participants: 84
Study Start date:
April 06, 2017
Estimated Completion Date:
December 20, 2017

Connect with a study center

  • Hospital General de Agudos J. A. Penna ; Breast Pathology

    Buenos Aires, 1437
    Argentina

    Site Not Available

  • Instituto Ángel H. Roffo - Universidad de Buenos Aires

    Buenos Aires, B1650
    Argentina

    Site Not Available

  • Hospital Julio C. Perrando

    Chaco,
    Argentina

    Site Not Available

  • Hospital General de Agudos Juan Antonio Fernandez

    Ciudad Autonoma de Buenos Aires, 1425
    Argentina

    Site Not Available

  • Hospital Pablo Soria

    Jujuy,
    Argentina

    Site Not Available

  • Centro Oncologico Riojano Integral (CORI)

    La Rioja, F5300COE
    Argentina

    Site Not Available

  • Hospital Interzonal General De Agudos "Luisa C. de Gandulfo"

    Lomas de Zamora,
    Argentina

    Site Not Available

  • Hospital Privado de Comunidad; Oncology

    Mar Del Plata, 7600
    Argentina

    Site Not Available

  • CENICLAR

    Rosario,
    Argentina

    Site Not Available

  • Hosp Provincial D. Centenarios; Oncology Dept

    Rosario, S2002KDS
    Argentina

    Site Not Available

  • Policlínico regional de San Luis

    San Luis,
    Argentina

    Site Not Available

  • Centro Medico San Roque

    San Miguel de Tucuman, T4000IAK
    Argentina

    Site Not Available

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