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

Cervical Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03071848
• Other study ID #: ML39360
• Status: Completed
• Phase: N/A
• First received: March 2, 2017
• Last updated: March 15, 2018
• Start date: April 6, 2017
• Est. completion date: December 20, 2017

Study information

• Verified date: March 2018
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: December 20, 2017
• Est. primary completion date: December 20, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

Other:
• No Intervention
This was an observational study.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Argentina, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Number of Doses of Prior Radiotherapy	Doses of prior radiotherapy will be reported.	Up to 12 months
Secondary	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
Secondary	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
Secondary	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
Secondary	Overall Survival (OS)	OS is defined as the time from the first dose of treatment to death from any cause.	Up to 12 months