This expanded access study will assess the safety and efficacy of intravenous bevacizumab (5 mg/kg every 2 weeks or 7.5 mg/kg every 3 weeks) in combination with fluoropyrimidine-based chemotherapy as first line treatment in participants with metastatic cancer of the colon or rectum. The anticipated time on study treatment is 3-12 months.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
168
5 mg/kg bevacizumab administered intravenously every 2 weeks or 7.5 mg/kg bevacizumab administered intravenously every 3 weeks according to the standard chemotherapy regimen.
Fluoropyrimidine-based chemotherapy administered according to standard of care.
Unnamed facility
Belo Horizonte, Brazil
Unnamed facility
Belo Horizonte, Brazil
Safety: Number of Participants With Serious and Specific Adverse Events
A serious adverse event was defined as any experience that suggested a significant hazard, contraindication, side effect, or precaution, and fulfilled any of the following criteria: fatal (resulted in death), life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was medically significant or required intervention to prevent any of the other outcomes listed here. Specific adverse events (Spec AEs) included the following: hypertension, bleeding/hemorrhage, proteinuria, wound healing complications, thrombosis/thrombus/embolism (t/t/e), thrombosis/thrombus/embolism - vascular access, gastrointestinal perforation, and infusion (injection) site reaction.
Time frame: Up to approximately 3 years
Efficacy: Overall Survival
Overall survival was measured as the time from start of first bevacizumab administration to death. For participants who were alive at the end of the study, data on survival were censored at the time of the last contact. Reported is the median duration of overall survival.
Time frame: Up to approximately 3 years
Efficacy: Time to Disease Progression
Time to disease progression was measured as the time from start of first bevacizumab administration to investigator-assessed progression. Progression was defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. For participants without disease progression at the end of the study, date and time to progression were censored at the last investigator assessment. Reported is the median time to disease progression.
Time frame: Up to approximately 3 years
Efficacy: Progression-free Survival
Progression-free survival (PFS) was measured as the time from start of first bevacizumab administration to investigator-assessed progression or death, whichever occurred first. Progression was defined using RECIST v1.0, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Reported is the median time of PFS.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Unnamed facility
Belo Horizonte, Brazil
Unnamed facility
Brasília, Brazil
Unnamed facility
Brasília, Brazil
Unnamed facility
Campinas, Brazil
Unnamed facility
Campinas, Brazil
Unnamed facility
Caxias do Sul, Brazil
Unnamed facility
Curitiba, Brazil
Unnamed facility
Curitiba, Brazil
...and 18 more locations
Time frame: Up to approximately 3 years