This expanded access study will assess the efficacy and safety of intravenous (IV) bevacizumab in combination with chemotherapy regimens as first-line treatment of metastatic cancer of the colon or rectum. The anticipated median time on study treatment is approximately 10 months, and the target sample size is 40 individuals.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Intravenous 5-fluorouracil based chemotherapy will be administered until disease progression or until termination of the study. The chemotherapy regimen will be at the discretion of the prescriber and will not be provided by the sponsor.
Bevacizumab will be administered IV 5 mg/kg every 2 weeks until disease progression or until termination of the study.
Irinotecan will be administered at the discretion of the prescriber until disease progression or until termination of the study.
Unnamed facility
Chai Yi, Taiwan
Unnamed facility
Kaohsiung City, Taiwan
Unnamed facility
Kaohsiung City, Taiwan
Unnamed facility
Taichung, Taiwan
Percentage of Participants With Adverse Events
An adverse event was any untoward medical occurrence attributed to study drug in a participant who received study drug.
Time frame: Baseline up to approximately 3 years
Percentage of Participants Who Died
Time frame: Baseline up to approximately 3 years
Duration of Survival
Duration of survival was defined as the time period from the start of first line therapy to death. Duration of survival was estimated using Kaplan-Meier analysis.
Time frame: Baseline up to approximately 3 years
Percentage of Participants With Disease Progression or Death
Disease progression was defined as at least a 20% increase in the disease measurement, taking as reference the smallest disease measurement recorded since the start of treatment, or the appearance of one or more new lesions, or evidence of clinical progression and unequivocal progression of existing non-target lesions (TL).
Time frame: Baseline up to approximately 3 years
Progression-Free Survival Time
Progression-free survival was defined as the duration from the date of starting first-line therapy to the date of documented disease progression or death from any cause. Disease progression was defined as at least a 20% increase in the disease measurement, taking as reference the smallest disease measurement recorded since the start of treatment, or the appearance of one or more new lesions, or evidence of clinical progression and unequivocal progression of existing non-TL. Progression-free survival was estimated using Kaplan-Meier analysis.
Time frame: Baseline up to approximately 3 years
Number of Participants With Best Overall Response
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Oxaliplatin will be administered at the discretion of the prescriber until disease progression or until termination of the study.
Unnamed facility
Taichung, Taiwan
Unnamed facility
Tainan, Taiwan
Unnamed facility
Tainan, Taiwan
Unnamed facility
Taipei, Taiwan
The best overall response was defined as the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started). Progressive disease (PD): at least a 20% increase in the disease measurement, taking as reference the smallest disease measurement recorded since the start of treatment, or the appearance of one or more new lesions, or evidence of clinical progression and unequivocal progression of existing non-TL. Complete response (CR): disappearance of all TL and non-TL. If immunocytology was available, no disease was to be detected by that methodology. Partial response (PR): at least a 30% decrease in the disease measurement, taking as reference the disease measurement done to confirm measurable disease at study entry. Stable disease (SD): neither sufficient shrinkage to qualify for PR or increase to qualify for PD.
Time frame: Baseline up to approximately 3 years
Mean Direct Medical Cost for Cancer Related Medical Care Utilization
Direct medical cost included cost of out-patient consultation and cost of hospitalization.
Time frame: Baseline up to approximately 3 years