A Study of Bevacizumab (Avastin) in Combination With Chemotherapy in Participants With Metastatic Cancer of the Colon or Rectum.
|ClinicalTrials.gov Identifier: NCT01169558|
Recruitment Status : Completed
First Posted : July 26, 2010
Results First Posted : October 18, 2016
Last Update Posted : December 8, 2016
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer||Drug: Bevacizumab Drug: Fluoropyrimidine-based Chemotherapy||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||168 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||First-Line Bevacizumab and Chemotherapy in Metastatic Cancer of the Colon or Rectum First BEAT (Bevacizumab Expanded Access Trial)- Brazilian Extension|
|Study Start Date :||May 2006|
|Actual Primary Completion Date :||July 2009|
|Actual Study Completion Date :||July 2009|
Bevacizumab will be administered in combination with fluoropyrimidine-based chemotherapy as first line treatment in participants with metastatic cancer of the colon or rectum until disease progression or study completion.
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.
Other Name: AvastinDrug: Fluoropyrimidine-based Chemotherapy
Fluoropyrimidine-based chemotherapy administered according to standard of care.
- Safety: Number of Participants With Serious and Specific Adverse Events [ Time Frame: Up to approximately 3 years ]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.
- Efficacy: Overall Survival [ Time Frame: Up to approximately 3 years ]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.
- Efficacy: Time to Disease Progression [ Time Frame: Up to approximately 3 years ]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.
- Efficacy: Progression-free Survival [ Time Frame: Up to approximately 3 years ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01169558
|Belo Horizonte, Brazil, 30140-083|
|Belo Horizonte, Brazil, 30150-221|
|Belo Horizonte, Brazil, 30150321|
|Brasilia, Brazil, 70390-150|
|Brasilia, Brazil, 70710-904|
|Campinas, Brazil, 13073-400|
|Campinas, Brazil, 13084-759|
|Caxias Do Sul, Brazil, 95020-450|
|Curitiba, Brazil, 80530-010|
|Curitiba, Brazil, 80730-180|
|Fortaleza, Brazil, 60741-420|
|Ijui, Brazil, 98700-000|
|Joao Pessoa, Brazil, 58040280|
|Porto Alegre, Brazil, 90020-090|
|Porto Alegre, Brazil, 90035-903|
|Recife, Brazil, 52012-220|
|Ribeirao Preto, Brazil, 14025-430|
|Rio de Janeiro, Brazil, 22031072|
|Rio de Janeiro, Brazil, 22631-004|
|Salvador, Brazil, 40170-110|
|Salvador, Brazil, 41810-012|
|Salvador, Brazil, 41950-610|
|Sao Paulo, Brazil, 01229-000|
|Sao Paulo, Brazil, 01232-010|
|Sao Paulo, Brazil, 01332-000|
|Sao Paulo, Brazil, 01406100|
|Sao Paulo, Brazil, 04122-000|
|Sao Paulo, Brazil, 05651-901|
|Study Chair:||Clinical Trials||Hoffmann-La Roche|