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

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

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.

Study Overview

• Status: Completed
• Conditions: Cervical Cancer
• Intervention / Treatment: Other: No Intervention

• Study Type: Observational
• Enrollment (Actual): 84

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, 1437
    • Hospital General de Agudos J. A. Penna ; Breast Pathology
  • Buenos Aires, Argentina, B1650
    • Instituto Ángel H. Roffo - Universidad de Buenos Aires
  • Chaco, Argentina
    • Hospital Julio C. Perrando
  • Ciudad Autonoma de Buenos Aires, Argentina, 1425
    • Hospital General de Agudos Juan Antonio Fernandez
  • Jujuy, Argentina
    • Hospital Pablo Soria
  • La Rioja, Argentina, F5300COE
    • Centro Oncologico Riojano Integral (CORI)
  • Lomas de Zamora, Argentina
    • Hospital Interzonal General De Agudos "Luisa C. de Gandulfo"
  • Mar Del Plata, Argentina, 7600
    • Hospital Privado de Comunidad; Oncology
  • Rosario, Argentina, S2002KDS
    • Hosp Provincial D. Centenarios; Oncology Dept
  • Rosario, Argentina
    • CENICLAR
  • San Luis, Argentina
    • Policlínico regional de San Luis
  • San Miguel de Tucuman, Argentina, T4000IAK
    • Centro Medico San Roque

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Participants with advanced cervical cancer (metastatic, recurrent or persistent) who have received treatment with bevacizumab from 01 January 2015 to 01 January 2016 will be observed.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Bevacizumab; 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.	Other: No Intervention; This was an observational study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Gastrointestinal (GI) and Genitourinary (GU) Fistulas and GI Perforations	Participants with GI and GU fistulas and GI perforation events will be reported according to Common Terminology Criteria for Adverse Events (CTCAE V4.0).	Up to 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants who Received Radiotherapy Prior to GI and GU Fistulas and GI Perforation Events	Participants who received radiotherapy prior to GI and GU fistulas and GI perforation events will be reported.	Up to 12 months
Percentage of Participants who Received Internal, External and Other Radiotherapy	Participants who received internal, external and other radiotherapy will be reported. External radiotherapy will include "Non Precision Orientated" that includes classic cobalt or "Precision Orientated" that includes Linear accelerator.	Up to 12 months
Number of Doses of Prior Radiotherapy	Doses of prior radiotherapy will be reported.	Up to 12 months
Percentage of Participants With Selected Adverse Events of Special Interest (AESIs)	Adverse events of special interest (AESI) for this study included: hypertension, proteinuria, wound healing complication, bleeding /haemorrrhage (including pulmonary haemorrhage and CNS bleeding), arterial and venous thromboembolic events (ATES; VTES), congestive heart failure (CHF), posterior reversible encephalopathy syndrome (PRES), fistula/abscess (other than genitourinary and gastrointestinal), gastrointestinal perforations and gallbladder perforation.	Up to 12 months
Overall Response Rate (ORR)	Overall response rate was defined as the percentage of participants who had confirmed complete response (CR) or partial response (PR). CR is defined as disappearance of all target and non-target lesions. PR is defined as at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. There can be no unequivocal progression of non-target lesions and no new lesions. In the case where the only target lesion is a solitary pelvic mass measured by physical exam, which is not radiographically measurable, a 50% decrease in the LD is required.	Up to 12 months
Progression Free Survival (PFS)	PFS is defined as the time from the first dose of treatment to the first occurrence of progression, or death from any cause as assessed by the investigator. Progressive disease (PD): at least a 20% increase in the sum of LD target lesions taking as reference the smallest sum LD recorded since study entry.	Up to 12 months
Overall Survival (OS)	OS is defined as the time from the first dose of treatment to death from any cause.	Up to 12 months

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start (Actual): April 6, 2017
• Primary Completion (Actual): December 20, 2017
• Study Completion (Actual): December 20, 2017

Study Registration Dates

• First Submitted: March 2, 2017
• First Submitted That Met QC Criteria: March 2, 2017
• First Posted (Actual): March 7, 2017

Study Record Updates

• Last Update Posted (Actual): March 16, 2018
• Last Update Submitted That Met QC Criteria: March 15, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Diseases; Uterine Cervical Neoplasms
• Other Study ID Numbers: ML39360