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

Roche

Status: Completed

Conditions: Cervical Cancer

Treatments: Other: No Intervention

Study type: Observational

Funder types: Industry

Identifiers

NCT03071848

ML39360

Details and patient eligibility

About

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.

Enrollment: 84 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 to curative 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 and paclitaxel) between 01 January 2015 and 01 January 2016
• All participants must have received at least one dose of bevacizumab combined with standard chemotherapy between 01 January 2015 and 01 January 2016 AND have at least 12 months of documented follow up, from treatment start, unless died or lost to follow up within the minimum study entry follow up period
• Availability of documentation of for advanced cervical cancer (including prior treatment as applicable) and follow up in the participant's medical records

Exclusion criteria

• Participation during the study period in an interventional clinical trial or any other interventional study that may impact advanced cervical cancer outcome
• Participants who have received prior therapy with any anti-VEGF drug, including bevacizumab

Trial design

84 participants in 1 patient group

Bevacizumab

Description:

Participants with advanced cervical cancer (metastatic, recurrent or persistent) who have received treatment with bevacizumab from 01 January 2015 to 01 January 2016 (retrospective and independent from this study) combined with standard chemotherapy (cisplatin/carboplatin or topotecan and paclitaxel) will be observed.

Treatment:

Other: No Intervention