A Phase 4 interventional study of 5-Fluorouracil and Bevacizumab in Colorectal Cancer, sponsored by Hoffmann-La Roche. Completed at 8 sites in Taiwan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-03-09.
Sponsored by Hoffmann-La Roche · Phase 4, Interventional, and Treatment
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.
5,734 studies on the registry are indexed under Colorectal Neoplasms; 1,481 are open to participants now.
This study's enrollment of 40 is below the median of 77 across 4,222 interventional studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →Hoffmann-La Roche is the lead sponsor of 2,099 studies on the registry; 88 are open to participants now.
Of its 324 completed or terminated interventional studies of FDA-regulated products, 245 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Participants will receive IV bevacizumab at a dose of 5 milligrams per kilogram (mg/kg) every 2 weeks in combination with standard of care chemotherapy regimen (5-Fluorouracil/Irinotecan/Oxaliplatin) until disease progression or until termination of the study.
Drug: 5-Fluorouracil · Drug: Bevacizumab · Drug: Irinotecan · Drug: Oxaliplatin
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.
Also known as: Avastin
Irinotecan will be administered at the discretion of the prescriber until disease progression or until termination of the study.
Oxaliplatin will be administered at the discretion of the prescriber until disease progression or until termination of the study.
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
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
| Milestone | Bevacizumab + Chemotherapy |
|---|---|
| Started | 40 |
| Completed | 40 |
| Not completed | 0 |
An adverse event was any untoward medical occurrence attributed to study drug in a participant who received study drug.
| percentage of participants | Bevacizumab + Chemotherapy |
|---|---|
| Percentage of Participants With Adverse Events | 100 |
| percentage of participants | Bevacizumab + Chemotherapy |
|---|---|
| Percentage of Participants Who Died | 62.5 |
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.
| months | Bevacizumab + Chemotherapy |
|---|---|
| Duration of Survival | 23.8 (13.7 to 27.2) |
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).
| percentage of participants | Bevacizumab + Chemotherapy |
|---|---|
| Percentage of Participants With Disease Progression or Death | 85.0 |
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.
| months | Bevacizumab + Chemotherapy |
|---|---|
| Progression-Free Survival Time | 12.2 (9.4 to 15.9) |
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.
| participants | Bevacizumab + Chemotherapy |
|---|---|
| CR | 2 |
| PR | 19 |
| PD | 8 |
| SD | 9 |
| Missing | 2 |
Direct medical cost included cost of out-patient consultation and cost of hospitalization.
| Thousands in New Taiwan Dollar | Bevacizumab + Chemotherapy |
|---|---|
| Out-Patient Consultation | 0.91 ± 0.407 |
| Hospitalization | 35.9 ± 12.8 |
Collected over Baseline up to approximately 3 years. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Bevacizumab + Chemotherapy | — | 14/40 (35%) | 40/40 (100%) |
| Event | Bevacizumab + Chemotherapy |
|---|---|
| Gastrointestinal haemorrhageGastrointestinal disorders | 3/40 |
| DiarrhoeaGastrointestinal disorders | 2/40 |
| LeukopeniaBlood and lymphatic system disorders | 1/40 |
| NeutropeniaBlood and lymphatic system disorders | 1/40 |
| Abdominal painGastrointestinal disorders | 1/40 |
| Disease progressionGeneral disorders | 1/40 |
| PyrexiaGeneral disorders | 1/40 |
| AbscessInfections and infestations | 1/40 |
| EpididymitisInfections and infestations | 1/40 |
| Incisional herniaInjury, poisoning and procedural complications | 1/40 |
| Event | Bevacizumab + Chemotherapy |
|---|---|
| NauseaGastrointestinal disorders | 27/40 |
| VomitingGastrointestinal disorders | 24/40 |
| FatigueGeneral disorders | 24/40 |
| DiarrhoeaGastrointestinal disorders | 22/40 |
| HypertensionVascular disorders | 16/40 |
| Decreased appetiteMetabolism and nutrition disorders | 15/40 |
| AlopeciaSkin and subcutaneous tissue disorders | 15/40 |
| StomatitisGastrointestinal disorders | 13/40 |
| PyrexiaGeneral disorders | 12/40 |
| Sensory level abnormalInvestigations | 11/40 |
Intent-to-treat (ITT) population included all participants receiving at least one dose of study drug.
| Age, Continuous(years) | Bevacizumab + Chemotherapy |
|---|---|
| Mean | 58.6 ± 13.18 |
| Sex: Female, Male(Participants) | Bevacizumab + Chemotherapy |
|---|---|
| Female | 15 |
| Male | 25 |
This study is completed, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Bevacizumab