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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03071848
Recruitment Status : Completed
First Posted : March 7, 2017
Last Update Posted : March 16, 2018
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

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.

Condition or disease Intervention/treatment
Cervical Cancer Other: No Intervention

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Study Type : Observational
Actual Enrollment : 84 participants
Observational Model: Cohort
Time Perspective: Retrospective
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
Actual Study Start Date : April 6, 2017
Actual Primary Completion Date : December 20, 2017
Actual Study Completion Date : December 20, 2017

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Percentage of Participants who Received Radiotherapy Prior to GI and GU Fistulas and GI Perforation Events [ Time Frame: Up to 12 months ]
    Participants who received radiotherapy prior to GI and GU fistulas and GI perforation events will be reported.

  2. Percentage of Participants who Received Internal, External and Other Radiotherapy [ Time Frame: Up to 12 months ]
    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.

  3. Number of Doses of Prior Radiotherapy [ Time Frame: Up to 12 months ]
    Doses of prior radiotherapy will be reported.

  4. Percentage of Participants With Selected Adverse Events of Special Interest (AESIs) [ Time Frame: Up to 12 months ]
    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.

  5. Overall Response Rate (ORR) [ Time Frame: Up to 12 months ]
    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.

  6. Progression Free Survival (PFS) [ Time Frame: Up to 12 months ]
    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.

  7. Overall Survival (OS) [ Time Frame: Up to 12 months ]
    OS is defined as the time from the first dose of treatment to death from any cause.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03071848


Locations
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Argentina
Hospital General de Agudos J. A. Penna ; Breast Pathology
Buenos Aires, Argentina, 1437
Instituto Ángel H. Roffo - Universidad de Buenos Aires
Buenos Aires, Argentina, B1650
Hospital Julio C. Perrando
Chaco, Argentina
Hospital General de Agudos Juan Antonio Fernandez
Ciudad Autonoma de Buenos Aires, Argentina, 1425
Hospital Pablo Soria
Jujuy, Argentina
Centro Oncologico Riojano Integral (CORI)
La Rioja, Argentina, F5300COE
Hospital Interzonal General De Agudos "Luisa C. de Gandulfo"
Lomas de Zamora, Argentina
Hospital Privado de Comunidad; Oncology
Mar Del Plata, Argentina, 7600
Hosp Provincial D. Centenarios; Oncology Dept
Rosario, Argentina, S2002KDS
CENICLAR
Rosario, Argentina
Policlínico regional de San Luis
San Luis, Argentina
Centro Medico San Roque
San Miguel de Tucuman, Argentina, T4000IAK
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT03071848    
Other Study ID Numbers: ML39360
First Posted: March 7, 2017    Key Record Dates
Last Update Posted: March 16, 2018
Last Verified: March 2018
Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases