Retrospective Multicenter Observational Study to Evaluate Safety and Effectiveness of Bevacizumab (Avastin®) in Combination With Paclitaxel and Cisplatin/Carboplatin or Toptecan in Patients With Advanced Cervical Cancer

Hoffmann-La Roche12 sites in 1 country84 target enrollmentApril 6, 2017

ConditionsCervical Cancer

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Cervical Cancer
Sponsor: Hoffmann-La Roche
Enrollment: 84
Locations: 12
Primary Endpoint: Percentage of Participants With Gastrointestinal (GI) and Genitourinary (GU) Fistulas and GI Perforations
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

April 6, 2017

End Date

December 20, 2017

Last Updated

8 years ago

Study Type

Observational

Sex

Female

Investigators

Sponsor

Hoffmann-La Roche

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Percentage of Participants With Gastrointestinal (GI) and Genitourinary (GU) Fistulas and GI Perforations

Time Frame: Up to 12 months

Participants with GI and GU fistulas and GI perforation events will be reported according to Common Terminology Criteria for Adverse Events (CTCAE V4.0).

Secondary Outcomes

Percentage of Participants With Selected Adverse Events of Special Interest (AESIs)(Up to 12 months)
Percentage of Participants who Received Radiotherapy Prior to GI and GU Fistulas and GI Perforation Events(Up to 12 months)
Percentage of Participants who Received Internal, External and Other Radiotherapy(Up to 12 months)
Number of Doses of Prior Radiotherapy(Up to 12 months)
Overall Response Rate (ORR)(Up to 12 months)
Progression Free Survival (PFS)(Up to 12 months)
Overall Survival (OS)(Up to 12 months)