Colorectal Cancer
Conditions
Brief summary
A study of Avastin (bevacizumab) in combination chemotherapy in patients with metastatic cancer of the colon or rectum. The anticipated time on study treatment is until disease progression.
Interventions
DRUGBevacizumab [Avastin]
Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle.
DRUGCapecitabine
Capecitabine was administered orally at a doses of 1000 or 1250, mg/m\^2 twice daily (Day 2 to 15) or as 650 mg/m\^2 twice daily on Days 1 to 21.
DRUGIrinotecan
Irinotecan was administered as a 240 mg/m\^2 intravenous infusion over 60 minutes (Day 1) every 3 weeks.
Sponsors
Hoffmann-La Roche
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* adult patients \>=18 years of age; * colon or rectal cancer, with metastases; * \>=1 measurable lesion.
Exclusion criteria
* previous systemic treatment for advanced disease; * radiotherapy to any site within 4 weeks before study; * daily aspirin (\>325 mg/day), anticoagulants, or other medications known to predispose to gastrointestinal ulceration; * co-existing malignancies or malignancies diagnosed within last 5 years (except basal cell cancer or cervical cancer in situ).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Disease Progression or Death | Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death | Disease progression was defined according to National Cancer Institute (NCI) guidelines and best clinical practices. |
| Time to Progression (TTP) | Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death | TTP is defined as the time from date of randomization until objective tumor progression or death due to any cause. It includes deaths and thus can be correlated to overall survival. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Treatment Failure | Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death | Treatment failure is defined as discontinuation of treatment for any reason, including disease progression, death, treatment toxicity, insufficient therapeutic response, failure to return, refusing treatment, being unwilling to cooperate and withdrawing consent. |
| Time to Treatment Failure | Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death | Time to treatment failure is defined as a composite endpoint measuring time from date of randomization to discontinuation of treatment for any reason, including disease progression, death, treatment toxicity, insufficient therapeutic response, failure to return, refusing treatment, being unwilling to cooperate and withdrawing consent. Analysis was performed using Kaplan-Meier estimates. |
| Percentage of Participants With Progression Excluding Deaths | Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death | The failure event was defined as tumor progression excluding deaths due to any reason. |
| Time to Progression Excluding Deaths | Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death | The failure event was defined as tumor progression excluding deaths due to any reason. Kaplan-Meier estimates were used for analysis. |
| Percentage of Participants With Progression Excluding Deaths Not Related to Underlying Cancer | Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death | The failure event was defined as tumor progression excluding only deaths not related to underlying cancer. |
| Time to Progression Excluding Deaths Not Related to Underlying Cancer | Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death | The failure event was defined as tumor progression excluding only deaths not related to underlying cancer. Kaplan-Meier estimates were used for analysis. |
| Percentage of Participants Who Died | Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death | Overall survival is defined as the time from date of randomization until death from any cause |
| Percentage of Participants With a Best Overall Response of CR or PR | Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death | CR: Complete disappearance of all target lesions; PR: At least 30% decrease in the sum of the longest diameter of all target lesions taking as reference the baseline sum of all target lesions; |
| Percentage of Participants With Stable Disease | Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death | Stable disease rate was the proportion of participants who achieved CR, PR, or SD. |
| Percentage of Participants With Progressive Disease Within 12 Weeks From Start of Treatment | Randomization, Weeks 3, 6 and 9, and 12 | Early progression was the proportion of participants with progressive disease within 12 weeks from the start of treatment. |
| Duration of Overall Response | Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death | Duration of overall response included participants who achieved a CR or PR. |
| Duration of Stable Disease (SD) | Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death | Duration of SD was calculated as the number of months the participants remained in CR, PR or SD. Kaplan-Meier estimates were used for analysis. |
| Duration of Overall Complete Response | Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years | Duration of complete response was calculated as the time in months from the date of randomization to the date of first documentation of CR. Kaplan-Meier estimates were used for analysis. |
| Percentage of Participants by Best Overall Response | Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death | Best overall response is defined as the best response recorded from the date of randomization until disease progression or recurrence. Complete response (CR): at least 2 determinations of CR at least 4 weeks apart before progression; Partial response (PR): at least 2 determinations of PR at least 4 weeks apart before progression; Stable disease (SD): at least one SD assessment; Progressive Disease (PD): Disease progression or death due to underlying cancer. CR: Complete disappearance of all target lesions; PR: At least 30% decrease in the sum of the longest diameter of all target lesions taking as reference the baseline sum of all target lesions; PD: At least 20% decrease in the sum of the longest diameter of all target lesions taking as reference the baseline sum of longest diameter of all target lesions or the appearance of one or more new lesions; SD: Neither sufficient shrinkage to qualify for CR or PR or increase in lesions; |
| Overall Survival | Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death | Overall survival is defined as the time from date of randomization until death from any cause; Kaplan-Meier estimates were used for analysis. |
Countries
Italy
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2) Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle. Irinotecan was administered as a 240 mg/m\^2 intravenous infusion over 60 minutes (Day 1) every 3 weeks. Capecitabine was administered orally at a dose of 1000 mg/m\^2 twice daily (Day 2 to 15). Cycle length was 3 weeks consisting of 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal. | 101 |
| Bevacizumab + Capecitabine (1250 mg/m^2) Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle in combination with capecitabine administered orally at 1250 mg/m\^2 twice daily (Day 1 to 14). Cycle length was 3 weeks with 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal. | 102 |
| Bevacizumab + Capecitabine (650 mg/m^2) Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 Week cycle in combination with capecitabine administered orally at 650 mg/m\^2 twice daily (Day 1 to 21). Cycle length was 3 weeks with 3 weeks of capecitabine treatment without interruptions. Participants received the same regimen until unacceptable toxicity, PD, or participant withdrawal. | 103 |
| Total | 306 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 22 | 12 | 17 |
| Overall Study | Death | 4 | 0 | 2 |
| Overall Study | Lost to Follow-up | 1 | 1 | 1 |
| Overall Study | Non-compliance | 3 | 0 | 0 |
| Overall Study | Other | 0 | 1 | 0 |
| Overall Study | Physician Decision | 10 | 6 | 8 |
| Overall Study | Progressive Disease | 58 | 77 | 71 |
| Overall Study | Protocol Violation | 1 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 2 | 4 | 3 |
Baseline characteristics
| Characteristic | Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2) | Bevacizumab + Capecitabine (1250 mg/m^2) | Bevacizumab + Capecitabine (650 mg/m^2) | Total |
|---|---|---|---|---|
| Age, Continuous | 61.60 years STANDARD_DEVIATION 9.35 | 61.46 years STANDARD_DEVIATION 10.22 | 61.01 years STANDARD_DEVIATION 10.1 | 61.36 years STANDARD_DEVIATION 9.86 |
| Sex: Female, Male Female | 58 Participants | 53 Participants | 63 Participants | 174 Participants |
| Sex: Female, Male Male | 43 Participants | 49 Participants | 40 Participants | 132 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 95 / 100 | 88 / 99 | 85 / 102 |
| serious Total, serious adverse events | 38 / 100 | 21 / 99 | 20 / 102 |
Outcome results
Primary
Percentage of Participants With Disease Progression or Death
Disease progression was defined according to National Cancer Institute (NCI) guidelines and best clinical practices.
Time frame: Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death
Population: ITT Population;
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2) | Percentage of Participants With Disease Progression or Death | 86.14 percentage of participants |
| Bevacizumab + Capecitabine (1250 mg/m^2) | Percentage of Participants With Disease Progression or Death | 90.20 percentage of participants |
| Bevacizumab + Capecitabine (650 mg/m^2) | Percentage of Participants With Disease Progression or Death | 88.35 percentage of participants |
Primary
Time to Progression (TTP)
TTP is defined as the time from date of randomization until objective tumor progression or death due to any cause. It includes deaths and thus can be correlated to overall survival.
Time frame: Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death
Population: ITT Population; only those participants with an event of disease progression or death were included in the analysis
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2) | Time to Progression (TTP) | 8.35 months |
| Bevacizumab + Capecitabine (1250 mg/m^2) | Time to Progression (TTP) | 8.15 months |
| Bevacizumab + Capecitabine (650 mg/m^2) | Time to Progression (TTP) | 7.27 months |
Secondary
Duration of Overall Complete Response
Duration of complete response was calculated as the time in months from the date of randomization to the date of first documentation of CR. Kaplan-Meier estimates were used for analysis.
Time frame: Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years
Population: ITT Population; Only participants with a best overall response were included in the analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2) | Duration of Overall Complete Response | 8.35 months |
| Bevacizumab + Capecitabine (1250 mg/m^2) | Duration of Overall Complete Response | 6.05 months |
| Bevacizumab + Capecitabine (650 mg/m^2) | Duration of Overall Complete Response | 12.89 months |
Secondary
Duration of Overall Response
Duration of overall response included participants who achieved a CR or PR.
Time frame: Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death
Population: ITT Population; only participants with a best overall response of CR or PR were included in the analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2) | Duration of Overall Response | 6.51 months |
| Bevacizumab + Capecitabine (1250 mg/m^2) | Duration of Overall Response | 6.61 months |
| Bevacizumab + Capecitabine (650 mg/m^2) | Duration of Overall Response | 9.12 months |
Secondary
Duration of Stable Disease (SD)
Duration of SD was calculated as the number of months the participants remained in CR, PR or SD. Kaplan-Meier estimates were used for analysis.
Time frame: Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death
Population: ITT Population; Only participants with a best overall response of CR, PR, or SD were included in the analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2) | Duration of Stable Disease (SD) | 8.81 months |
| Bevacizumab + Capecitabine (1250 mg/m^2) | Duration of Stable Disease (SD) | 8.65 months |
| Bevacizumab + Capecitabine (650 mg/m^2) | Duration of Stable Disease (SD) | 8.98 months |
Secondary
Overall Survival
Overall survival is defined as the time from date of randomization until death from any cause; Kaplan-Meier estimates were used for analysis.
Time frame: Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death
Population: ITT Population; Only participants with an event (death) were included in the analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2) | Overall Survival | 22.75 months |
| Bevacizumab + Capecitabine (1250 mg/m^2) | Overall Survival | 19.76 months |
| Bevacizumab + Capecitabine (650 mg/m^2) | Overall Survival | 18.02 months |
Secondary
Percentage of Participants by Best Overall Response
Best overall response is defined as the best response recorded from the date of randomization until disease progression or recurrence. Complete response (CR): at least 2 determinations of CR at least 4 weeks apart before progression; Partial response (PR): at least 2 determinations of PR at least 4 weeks apart before progression; Stable disease (SD): at least one SD assessment; Progressive Disease (PD): Disease progression or death due to underlying cancer. CR: Complete disappearance of all target lesions; PR: At least 30% decrease in the sum of the longest diameter of all target lesions taking as reference the baseline sum of all target lesions; PD: At least 20% decrease in the sum of the longest diameter of all target lesions taking as reference the baseline sum of longest diameter of all target lesions or the appearance of one or more new lesions; SD: Neither sufficient shrinkage to qualify for CR or PR or increase in lesions;
Time frame: Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death
Population: ITT Population; All participants with evaluable data were included in the analysis
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2) | Percentage of Participants by Best Overall Response | CR | 5.49 percentage of participants |
| Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2) | Percentage of Participants by Best Overall Response | PR | 46.15 percentage of participants |
| Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2) | Percentage of Participants by Best Overall Response | SD | 39.56 percentage of participants |
| Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2) | Percentage of Participants by Best Overall Response | PD | 8.79 percentage of participants |
| Bevacizumab + Capecitabine (1250 mg/m^2) | Percentage of Participants by Best Overall Response | PD | 14.13 percentage of participants |
| Bevacizumab + Capecitabine (1250 mg/m^2) | Percentage of Participants by Best Overall Response | CR | 1.09 percentage of participants |
| Bevacizumab + Capecitabine (1250 mg/m^2) | Percentage of Participants by Best Overall Response | SD | 52.17 percentage of participants |
| Bevacizumab + Capecitabine (1250 mg/m^2) | Percentage of Participants by Best Overall Response | PR | 32.61 percentage of participants |
| Bevacizumab + Capecitabine (650 mg/m^2) | Percentage of Participants by Best Overall Response | PD | 20.21 percentage of participants |
| Bevacizumab + Capecitabine (650 mg/m^2) | Percentage of Participants by Best Overall Response | PR | 28.72 percentage of participants |
| Bevacizumab + Capecitabine (650 mg/m^2) | Percentage of Participants by Best Overall Response | SD | 45.74 percentage of participants |
| Bevacizumab + Capecitabine (650 mg/m^2) | Percentage of Participants by Best Overall Response | CR | 5.32 percentage of participants |
Secondary
Percentage of Participants Who Died
Overall survival is defined as the time from date of randomization until death from any cause
Time frame: Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death
Population: ITT Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2) | Percentage of Participants Who Died | 67.33 percentage of participants |
| Bevacizumab + Capecitabine (1250 mg/m^2) | Percentage of Participants Who Died | 71.57 percentage of participants |
| Bevacizumab + Capecitabine (650 mg/m^2) | Percentage of Participants Who Died | 73.79 percentage of participants |
Secondary
Percentage of Participants With a Best Overall Response of CR or PR
CR: Complete disappearance of all target lesions; PR: At least 30% decrease in the sum of the longest diameter of all target lesions taking as reference the baseline sum of all target lesions;
Time frame: Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death
Population: ITT Population; All participants with evaluable data were included in the analysis
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2) | Percentage of Participants With a Best Overall Response of CR or PR | 52.0 percentage of participants |
| Bevacizumab + Capecitabine (1250 mg/m^2) | Percentage of Participants With a Best Overall Response of CR or PR | 34.0 percentage of participants |
| Bevacizumab + Capecitabine (650 mg/m^2) | Percentage of Participants With a Best Overall Response of CR or PR | 34.0 percentage of participants |
Secondary
Percentage of Participants With Progression Excluding Deaths
The failure event was defined as tumor progression excluding deaths due to any reason.
Time frame: Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death
Population: ITT Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2) | Percentage of Participants With Progression Excluding Deaths | 71.29 percentage of participants |
| Bevacizumab + Capecitabine (1250 mg/m^2) | Percentage of Participants With Progression Excluding Deaths | 81.37 percentage of participants |
| Bevacizumab + Capecitabine (650 mg/m^2) | Percentage of Participants With Progression Excluding Deaths | 75.73 percentage of participants |
Secondary
Percentage of Participants With Progression Excluding Deaths Not Related to Underlying Cancer
The failure event was defined as tumor progression excluding only deaths not related to underlying cancer.
Time frame: Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death
Population: ITT Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2) | Percentage of Participants With Progression Excluding Deaths Not Related to Underlying Cancer | 81.19 percentage of participants |
| Bevacizumab + Capecitabine (1250 mg/m^2) | Percentage of Participants With Progression Excluding Deaths Not Related to Underlying Cancer | 90.20 percentage of participants |
| Bevacizumab + Capecitabine (650 mg/m^2) | Percentage of Participants With Progression Excluding Deaths Not Related to Underlying Cancer | 85.44 percentage of participants |
Secondary
Percentage of Participants With Progressive Disease Within 12 Weeks From Start of Treatment
Early progression was the proportion of participants with progressive disease within 12 weeks from the start of treatment.
Time frame: Randomization, Weeks 3, 6 and 9, and 12
Population: ITT Population; All participants with evaluable data were included in the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2) | Percentage of Participants With Progressive Disease Within 12 Weeks From Start of Treatment | 9.0 percentage of participants |
| Bevacizumab + Capecitabine (1250 mg/m^2) | Percentage of Participants With Progressive Disease Within 12 Weeks From Start of Treatment | 13.0 percentage of participants |
| Bevacizumab + Capecitabine (650 mg/m^2) | Percentage of Participants With Progressive Disease Within 12 Weeks From Start of Treatment | 18.0 percentage of participants |
Secondary
Percentage of Participants With Stable Disease
Stable disease rate was the proportion of participants who achieved CR, PR, or SD.
Time frame: Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death
Population: ITT Population; All participants with evaluable data were included in the analysis
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2) | Percentage of Participants With Stable Disease | 91.0 percentage of participants |
| Bevacizumab + Capecitabine (1250 mg/m^2) | Percentage of Participants With Stable Disease | 86.0 percentage of participants |
| Bevacizumab + Capecitabine (650 mg/m^2) | Percentage of Participants With Stable Disease | 80.0 percentage of participants |
Secondary
Percentage of Participants With Treatment Failure
Treatment failure is defined as discontinuation of treatment for any reason, including disease progression, death, treatment toxicity, insufficient therapeutic response, failure to return, refusing treatment, being unwilling to cooperate and withdrawing consent.
Time frame: Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death
Population: ITT Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2) | Percentage of Participants With Treatment Failure | 100.0 percentage of participants |
| Bevacizumab + Capecitabine (1250 mg/m^2) | Percentage of Participants With Treatment Failure | 99.02 percentage of participants |
| Bevacizumab + Capecitabine (650 mg/m^2) | Percentage of Participants With Treatment Failure | 99.03 percentage of participants |
Secondary
Time to Progression Excluding Deaths
The failure event was defined as tumor progression excluding deaths due to any reason. Kaplan-Meier estimates were used for analysis.
Time frame: Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death
Population: ITT Population; Only participants with a time to progression event (excluding deaths) were included in the analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2) | Time to Progression Excluding Deaths | 8.81 months |
| Bevacizumab + Capecitabine (1250 mg/m^2) | Time to Progression Excluding Deaths | 8.48 months |
| Bevacizumab + Capecitabine (650 mg/m^2) | Time to Progression Excluding Deaths | 7.40 months |
Secondary
Time to Progression Excluding Deaths Not Related to Underlying Cancer
The failure event was defined as tumor progression excluding only deaths not related to underlying cancer. Kaplan-Meier estimates were used for analysis.
Time frame: Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death
Population: ITT Population; only participants with a time to progression event (excluding deaths not related to underlying cancer) were included in the analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2) | Time to Progression Excluding Deaths Not Related to Underlying Cancer | 8.68 months |
| Bevacizumab + Capecitabine (1250 mg/m^2) | Time to Progression Excluding Deaths Not Related to Underlying Cancer | 8.32 months |
| Bevacizumab + Capecitabine (650 mg/m^2) | Time to Progression Excluding Deaths Not Related to Underlying Cancer | 7.27 months |
Secondary
Time to Treatment Failure
Time to treatment failure is defined as a composite endpoint measuring time from date of randomization to discontinuation of treatment for any reason, including disease progression, death, treatment toxicity, insufficient therapeutic response, failure to return, refusing treatment, being unwilling to cooperate and withdrawing consent. Analysis was performed using Kaplan-Meier estimates.
Time frame: Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death
Population: ITT Population; only participants with a treatment failure event were included in the analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2) | Time to Treatment Failure | 6.67 months |
| Bevacizumab + Capecitabine (1250 mg/m^2) | Time to Treatment Failure | 6.87 months |
| Bevacizumab + Capecitabine (650 mg/m^2) | Time to Treatment Failure | 5.75 months |