This study is to assess safety as defined by the frequency and severity of gastrointestinal (GI) perforation/fistula, GI-vaginal fistula and genitourinary (GU) fistula in participants treated with bevacizumab 15 milligrams per kilogram (mg/kg) in combination with paclitaxel and carboplatin, all repeated every 3 weeks, for recurrent, persistent or metastatic cervical cancer. In addition, this study will include evaluation of the overall safety profile of bevacizumab in combination with paclitaxel and carboplatin in this setting, assessment of GI perforation/fistula, GI-vaginal fistula and GU fistula events over time, and evaluation of efficacy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
152
Intravenous (i.v.) administration of 15 mg/kg bevacizumab once every 3 weeks
Administration of carboplatin at 5 milligrams per milliliter\*minute (mg/mL\*min) on Day 1 every 3 weeks for at least 6 cycles
Administration of paclitaxel at a dose of 175 milligrams per square meter (mg/m\^2) on Day 1 every 3 weeks for at least 6 cycles
Centro Oncologico Riojano Integral (CORI)
La Rioja, Argentina
Hospital das Clinicas - UFMG
Belo Horizonte, Minas Gerais, Brazil
Oncologica Brasil S/S LTDA - EPP
Belém, Pará, Brazil
Instituto Nacional de Cancer - INCa; Pesquisa Clinica
Rio de Janerio, Rio de Janeiro, Brazil
Instituto do Cancer do Estado de Sao Paulo - ICESP
São Paulo, São Paulo, Brazil
Percentage of Participants with GI Perforation/Fistula Events by Grade According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.0
Time frame: Baseline up to 24 months
Percentage of Participants with GI-Vaginal Fistula Events by Grade According to NCI-CTCAE Version 4.0
Time frame: Baseline up to 24 months
Percentage of Participants with GU Fistula Events by Grade According to NCI-CTCAE Version 4.0
Time frame: Baseline up to 24 months
Time to First GI Perforation/Fistula
Time frame: Baseline up to 24 months
Time to First GI-Vaginal Fistula
Time frame: Baseline up to 24 months
Time to First GU Fistula
Time frame: Baseline up to 24 months
Dose Intensity (Ratio of Actual Dose Administered Versus Intended Dose) for Bevacizumab During the Treatment Period
Time frame: Baseline up to 24 months
Dose Intensity (Ratio of Actual Dose Administered Versus Intended Dose) for Carboplatin During the Treatment Period
Time frame: Baseline up to 24 months
Dose Intensity (Ratio of Actual Dose Administered Versus Intended Dose) for Paclitaxel During the Treatment Period
Time frame: Baseline up to 24 months
Duration of Treatment for Bevacizumab
Time frame: Baseline up to 24 months
Duration of Treatment for Carboplatin
Time frame: Baseline up to 24 months
Duration of Treatment for Paclitaxel
Time frame: Baseline up to 24 months
Percentage of Participants with Adverse Events (AEs)
Time frame: Baseline up to 24 months
Percentage of Participants with Serious Adverse Events (SAEs)
Time frame: Baseline up to 24 months
Percentage of Participants with Adverse Events of Special Interest (AESIs)
Time frame: Baseline up to 24 months
Percentage of Participants with AEs Leading to Treatment Interruption or Permanent discontinuation
Time frame: Baseline up to 24 months
Percentage of Deaths Causally Related to Treatment
Time frame: Baseline up to 24 months
Progression-Free Survival (PFS) According to Response Evaluation Criteria for Solid Tumors (RECIST) Version 1.1
Time frame: Baseline up to 24 months
Overall Survival (OS)
Time frame: Baseline up to 24 months
Percentage of Participants with a Best Overall Response of Complete Response (CR) or Partial Response (PR) According to RECIST Version 1.1
Time frame: Baseline up to 24 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Complex Oncological Center - Plovdiv, EOOD
Plovdiv, Bulgaria
MHAT Nadezhda
Sofia, Bulgaria
Oncomedica S.A.
Montería, Colombia
Oncólogos de Occidente
Pereira, Colombia
Clinica CIMCA
San José, Costa Rica
...and 33 more locations