Trial Outcomes & Findings for Irinotecan and Cetuximab With or Without Bevacizumab in Treating Patients With RAS Wild-Type Locally Advanced or Metastatic Colorectal Cancer That Cannot Be Removed by Surgery (NCT NCT02292758)
NCT ID: NCT02292758
Last Updated: 2022-01-31
Results Overview
The distribution of PFS by group will be estimated using the method of Kaplan-Meier. Median by treatment group with confidence intervals will be estimated based on Kaplan-Meier curves. The hazard ratio (HR) with confidence interval will be estimated based on stratified Cox models (stratified by levels of stratification factors), without and with adjusting for baseline clinical/pathological factors. Progression (PD) is defined according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. PD: Any new lesion or increase by ≥50% of previously involved sites from nadir).
COMPLETED
PHASE2
36 participants
From the date of randomization to the date of 1st documented disease progression or death due to any cause, whichever occurs first, assessed up to 24 months
2022-01-31
Participant Flow
Participant milestones
| Measure |
Arm I (Irinotecan, Cetuximab, Bevacizumab)
Patients receive 500 mg/m\^2 cetuximab IV over 90-120 minutes, 5 mg/kg bevacizumab IV over 30-90 minutes, and 180 mg/m\^2 irinotecan IV over 90 minutes on day 1. Cycles repeat every 14 days in the absence of disease progression or unacceptable toxicity.
|
Arm II (Irinotecan, Cetuximab, Placebo)
Patients receive 500 mg/m\^2 cetuximab IV over 90-120 minutes, 5 mg/kg placebo IV over 30-90 minutes, and 180 mg/m\^2 irinotecan IV over 90 minutes on day 1. Cycles repeat every 14 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Overall Study
STARTED
|
19
|
17
|
|
Overall Study
COMPLETED
|
19
|
17
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Irinotecan and Cetuximab With or Without Bevacizumab in Treating Patients With RAS Wild-Type Locally Advanced or Metastatic Colorectal Cancer That Cannot Be Removed by Surgery
Baseline characteristics by cohort
| Measure |
Arm I (Irinotecan, Cetuximab, Bevacizumab)
n=19 Participants
Patients receive 500 mg/m\^2 cetuximab IV over 90-120 minutes, 5 mg/kg bevacizumab IV over 30-90 minutes, and 180 mg/m\^2 irinotecan IV over 90 minutes on day 1. Cycles repeat every 14 days in the absence of disease progression or unacceptable toxicity.
|
Arm II (Irinotecan, Cetuximab, Placebo)
n=17 Participants
Patients receive 500 mg/m\^2 cetuximab IV over 90-120 minutes, 5 mg/kg placebo IV over 30-90 minutes, and 180 mg/m\^2 irinotecan IV over 90 minutes on day 1. Cycles repeat every 14 days in the absence of disease progression or unacceptable toxicity.
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58 years
n=99 Participants
|
54 years
n=107 Participants
|
55 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
30 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
ECOG Performance Status
0
|
14 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
26 Participants
n=206 Participants
|
|
ECOG Performance Status
1
|
5 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: From the date of randomization to the date of 1st documented disease progression or death due to any cause, whichever occurs first, assessed up to 24 monthsThe distribution of PFS by group will be estimated using the method of Kaplan-Meier. Median by treatment group with confidence intervals will be estimated based on Kaplan-Meier curves. The hazard ratio (HR) with confidence interval will be estimated based on stratified Cox models (stratified by levels of stratification factors), without and with adjusting for baseline clinical/pathological factors. Progression (PD) is defined according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. PD: Any new lesion or increase by ≥50% of previously involved sites from nadir).
Outcome measures
| Measure |
Arm I (Irinotecan, Cetuximab, Bevacizumab)
n=19 Participants
Patients receive 500 mg/m\^2 cetuximab IV over 90-120 minutes, 5 mg/kg bevacizumab IV over 30-90 minutes, and 180 mg/m\^2 irinotecan IV over 90 minutes on day 1. Cycles repeat every 14 days in the absence of disease progression or unacceptable toxicity.
|
Arm II (Irinotecan, Cetuximab, Placebo)
n=17 Participants
Patients receive 500 mg/m\^2 cetuximab IV over 90-120 minutes, 5 mg/kg placebo IV over 30-90 minutes, and 180 mg/m\^2 irinotecan IV over 90 minutes on day 1. Cycles repeat every 14 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Progression-Free Survival (PFS)
|
9.7 months
Interval 7.1 to 13.7
|
5.5 months
Interval 3.8 to 10.2
|
PRIMARY outcome
Timeframe: From the date of randomization to the date of 1st documented disease progression or death due to any cause, whichever occurs first, assessed up to 24 monthsThe distribution of PFS by group will be estimated using the method of Kaplan-Meier. Six and 12 month PFS rates by treatment group with confidence intervals will be estimated based on Kaplan-Meier curves. The hazard ratio (HR) with confidence interval will be estimated based on stratified Cox models (stratified by levels of stratification factors), without and with adjusting for baseline clinical/pathological factors. Progression (PD) is defined according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. PD: Any new lesion or increase by ≥50% of previously involved sites from nadir).
Outcome measures
| Measure |
Arm I (Irinotecan, Cetuximab, Bevacizumab)
n=19 Participants
Patients receive 500 mg/m\^2 cetuximab IV over 90-120 minutes, 5 mg/kg bevacizumab IV over 30-90 minutes, and 180 mg/m\^2 irinotecan IV over 90 minutes on day 1. Cycles repeat every 14 days in the absence of disease progression or unacceptable toxicity.
|
Arm II (Irinotecan, Cetuximab, Placebo)
n=17 Participants
Patients receive 500 mg/m\^2 cetuximab IV over 90-120 minutes, 5 mg/kg placebo IV over 30-90 minutes, and 180 mg/m\^2 irinotecan IV over 90 minutes on day 1. Cycles repeat every 14 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
6-month and 12-month Progression-free Survival (PFS) Rates
6-month PFS rate
|
76.5 percentage of participants
Interval 58.7 to 99.5
|
41.2 percentage of participants
Interval 23.3 to 72.7
|
|
6-month and 12-month Progression-free Survival (PFS) Rates
12-month PFS rate
|
27.5 percentage of participants
Interval 12.3 to 61.2
|
17.6 percentage of participants
Interval 6.3 to 49.3
|
SECONDARY outcome
Timeframe: Up to 30 days from last dose of study treatmentThe number of participants who experienced at least one grade 3 or higher adverse events assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0.
Outcome measures
| Measure |
Arm I (Irinotecan, Cetuximab, Bevacizumab)
n=19 Participants
Patients receive 500 mg/m\^2 cetuximab IV over 90-120 minutes, 5 mg/kg bevacizumab IV over 30-90 minutes, and 180 mg/m\^2 irinotecan IV over 90 minutes on day 1. Cycles repeat every 14 days in the absence of disease progression or unacceptable toxicity.
|
Arm II (Irinotecan, Cetuximab, Placebo)
n=17 Participants
Patients receive 500 mg/m\^2 cetuximab IV over 90-120 minutes, 5 mg/kg placebo IV over 30-90 minutes, and 180 mg/m\^2 irinotecan IV over 90 minutes on day 1. Cycles repeat every 14 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Number of Participants Who Experienced at Least One Grade 3 or Higher Adverse Events
|
9 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: From randomization to the date of death due to any cause, assessed up to 24 monthsThe distribution of OS by group will be estimated using the method of Kaplan-Meier. Median OS by treatment group with confidence intervals will be estimated based on Kaplan-Meier curves. The HR with confidence interval will be estimated based on stratified Cox models (stratified by levels of stratification factors), without and with adjusting for baseline clinical/pathological factors.
Outcome measures
| Measure |
Arm I (Irinotecan, Cetuximab, Bevacizumab)
n=19 Participants
Patients receive 500 mg/m\^2 cetuximab IV over 90-120 minutes, 5 mg/kg bevacizumab IV over 30-90 minutes, and 180 mg/m\^2 irinotecan IV over 90 minutes on day 1. Cycles repeat every 14 days in the absence of disease progression or unacceptable toxicity.
|
Arm II (Irinotecan, Cetuximab, Placebo)
n=17 Participants
Patients receive 500 mg/m\^2 cetuximab IV over 90-120 minutes, 5 mg/kg placebo IV over 30-90 minutes, and 180 mg/m\^2 irinotecan IV over 90 minutes on day 1. Cycles repeat every 14 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Overall Survival (OS)
|
19.7 months
Interval 14.9 to
The 95% confidence interval upper limit was not reached (i.e. under the level of detection).
|
10.2 months
Interval 7.9 to 16.0
|
SECONDARY outcome
Timeframe: From randomization to the date of death due to any cause, assessed up to 24 monthsThe distribution of OS by group will be estimated using the method of Kaplan-Meier. Twelve, 18- and 24-month survival rates by treatment group with confidence intervals will be estimated based on Kaplan-Meier curves. The HR with confidence interval will be estimated based on stratified Cox models (stratified by levels of stratification factors), without and with adjusting for baseline clinical/pathological factors.
Outcome measures
| Measure |
Arm I (Irinotecan, Cetuximab, Bevacizumab)
n=19 Participants
Patients receive 500 mg/m\^2 cetuximab IV over 90-120 minutes, 5 mg/kg bevacizumab IV over 30-90 minutes, and 180 mg/m\^2 irinotecan IV over 90 minutes on day 1. Cycles repeat every 14 days in the absence of disease progression or unacceptable toxicity.
|
Arm II (Irinotecan, Cetuximab, Placebo)
n=17 Participants
Patients receive 500 mg/m\^2 cetuximab IV over 90-120 minutes, 5 mg/kg placebo IV over 30-90 minutes, and 180 mg/m\^2 irinotecan IV over 90 minutes on day 1. Cycles repeat every 14 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
12-month, 18-month, and 24-month Overall Survival (OS) Rates
12-month OS rate
|
77.2 percentage of participants
Interval 59.7 to 99.8
|
47.1 percentage of participants
Interval 28.4 to 77.9
|
|
12-month, 18-month, and 24-month Overall Survival (OS) Rates
18-month OS rate
|
56.1 percentage of participants
Interval 36.0 to 87.5
|
11.8 percentage of participants
Interval 3.2 to 43.2
|
|
12-month, 18-month, and 24-month Overall Survival (OS) Rates
24-month OS rate
|
14.0 percentage of participants
Interval 2.4 to 81.1
|
5.9 percentage of participants
Interval 0.9 to 39.4
|
SECONDARY outcome
Timeframe: Up to 2 yearsDisease control is defined as maintaining Complete Response (CR) or Partial Response (PR) or Stable Disease (SD) as the tumor assessment result during the defined time window. DCR (percentage) is defined as number of patients with success of disease control divided by total number of patients in the analysis population multiplied by 100, excluding patients who refuse treatment before the initiation of any treatment. CR: Disappearance of all evidence of disease, PR: Regression of measurable disease and no new sites, PD: Any new lesion or increase by ≥50% of previously involved sites from nadir, SD: Neither sufficient shrinkage to qualify for PR, nor sufficient increase to qualify for PD taking as reference the MSD
Outcome measures
| Measure |
Arm I (Irinotecan, Cetuximab, Bevacizumab)
n=19 Participants
Patients receive 500 mg/m\^2 cetuximab IV over 90-120 minutes, 5 mg/kg bevacizumab IV over 30-90 minutes, and 180 mg/m\^2 irinotecan IV over 90 minutes on day 1. Cycles repeat every 14 days in the absence of disease progression or unacceptable toxicity.
|
Arm II (Irinotecan, Cetuximab, Placebo)
n=17 Participants
Patients receive 500 mg/m\^2 cetuximab IV over 90-120 minutes, 5 mg/kg placebo IV over 30-90 minutes, and 180 mg/m\^2 irinotecan IV over 90 minutes on day 1. Cycles repeat every 14 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Disease Control Rate (DCR)
|
68.4 percentage of participants
|
52.9 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 2 yearsThe response rate (percentage) is the percent of participants whose best response was Complete Response (CR) or Partial Response (PR) as defined by RECIST 1.1 criteria. Percentage of successes will be estimated by 100 times the number of successes divided by the total number of evaluable patients. Response rates (including complete and partial response) will be tested using Fisher's exact test. CR: Disappearance of all evidence of disease, PR: Regression of measurable disease and no new sites
Outcome measures
| Measure |
Arm I (Irinotecan, Cetuximab, Bevacizumab)
n=19 Participants
Patients receive 500 mg/m\^2 cetuximab IV over 90-120 minutes, 5 mg/kg bevacizumab IV over 30-90 minutes, and 180 mg/m\^2 irinotecan IV over 90 minutes on day 1. Cycles repeat every 14 days in the absence of disease progression or unacceptable toxicity.
|
Arm II (Irinotecan, Cetuximab, Placebo)
n=17 Participants
Patients receive 500 mg/m\^2 cetuximab IV over 90-120 minutes, 5 mg/kg placebo IV over 30-90 minutes, and 180 mg/m\^2 irinotecan IV over 90 minutes on day 1. Cycles repeat every 14 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Overall Response Rate (ORR)
|
36.8 percentage of participants
|
11.8 percentage of participants
|
SECONDARY outcome
Timeframe: From the date of first tumor assessment with the response status being CR or PR to the date of 1st documented progressive disease, assessed up to 12 monthsPopulation: Participants who responded to treatment (CR or PR) are included in this analysis.
The distribution of DOR by treatment group will be estimated using the method of Kaplan-Meier. Six and 12 month durable response (i.e. maintaining CR or PR without progressive disease \[PD\]) rates by treatment group with confidence intervals will be estimated based on Kaplan-Meier curves. The HR with confidence interval will be estimated based on stratified Cox models (stratified by levels of stratification factors), without and with adjusting for baseline clinical/pathological factors.CR: Disappearance of all evidence of disease, PR: Regression of measurable disease and no new sites, PD: Any new lesion or increase by ≥50% of previously involved sites from nadir
Outcome measures
| Measure |
Arm I (Irinotecan, Cetuximab, Bevacizumab)
n=7 Participants
Patients receive 500 mg/m\^2 cetuximab IV over 90-120 minutes, 5 mg/kg bevacizumab IV over 30-90 minutes, and 180 mg/m\^2 irinotecan IV over 90 minutes on day 1. Cycles repeat every 14 days in the absence of disease progression or unacceptable toxicity.
|
Arm II (Irinotecan, Cetuximab, Placebo)
n=2 Participants
Patients receive 500 mg/m\^2 cetuximab IV over 90-120 minutes, 5 mg/kg placebo IV over 30-90 minutes, and 180 mg/m\^2 irinotecan IV over 90 minutes on day 1. Cycles repeat every 14 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Duration of Response (DOR)
|
9.2 months
Interval 3.5 to 14.8
|
9.7 months
Interval 3.7 to 15.6
|
SECONDARY outcome
Timeframe: assessed at 6 monthsTTF is defined as the time from the date of randomization to the date of treatment discontinuation due to PD, death, or severe AE. The distribution of TTF by treatment group will be estimated using the method of Kaplan-Meier. Six month event-free rates by treatment group with confidence intervals will be estimated based on Kaplan-Meier curves. The HR with confidence interval will be estimated based on stratified Cox models (stratified by levels of stratification factors), without and with adjusting for baseline clinical/pathological factors. PD: Any new lesion or increase by ≥50% of previously involved sites from nadir
Outcome measures
| Measure |
Arm I (Irinotecan, Cetuximab, Bevacizumab)
n=19 Participants
Patients receive 500 mg/m\^2 cetuximab IV over 90-120 minutes, 5 mg/kg bevacizumab IV over 30-90 minutes, and 180 mg/m\^2 irinotecan IV over 90 minutes on day 1. Cycles repeat every 14 days in the absence of disease progression or unacceptable toxicity.
|
Arm II (Irinotecan, Cetuximab, Placebo)
n=17 Participants
Patients receive 500 mg/m\^2 cetuximab IV over 90-120 minutes, 5 mg/kg placebo IV over 30-90 minutes, and 180 mg/m\^2 irinotecan IV over 90 minutes on day 1. Cycles repeat every 14 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Percentage of Participants With Treatment Failure at 6 Months
|
72.7 percentage of participants
Interval 54.9 to 96.3
|
38.4 percentage of participants
Interval 19.7 to 74.8
|
SECONDARY outcome
Timeframe: Up to 2 yearsRDI is defined as the total dose of protocol therapy a patient actually received (i.e., summation of actually received dose at each cycle) divided by the total planned dose (i.e., summation of planned dose level at each cycle) multiplied by 100. Separate RDIs will be calculated for irinotecan and cetuximab. Agent-specific RDI will be summarized by medians, and min and max values, all of which will be compared between the two treatment groups by the Wilcoxon Rank sum test.
Outcome measures
| Measure |
Arm I (Irinotecan, Cetuximab, Bevacizumab)
n=19 Participants
Patients receive 500 mg/m\^2 cetuximab IV over 90-120 minutes, 5 mg/kg bevacizumab IV over 30-90 minutes, and 180 mg/m\^2 irinotecan IV over 90 minutes on day 1. Cycles repeat every 14 days in the absence of disease progression or unacceptable toxicity.
|
Arm II (Irinotecan, Cetuximab, Placebo)
n=17 Participants
Patients receive 500 mg/m\^2 cetuximab IV over 90-120 minutes, 5 mg/kg placebo IV over 30-90 minutes, and 180 mg/m\^2 irinotecan IV over 90 minutes on day 1. Cycles repeat every 14 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Relative Dose Intensity (RDI)
Cetuximab
|
98.5 percentage of dose received
Interval 60.9 to 152.9
|
95.5 percentage of dose received
Interval 40.0 to 103.4
|
|
Relative Dose Intensity (RDI)
Irinotecan
|
89 percentage of dose received
Interval 40.8 to 154.1
|
90 percentage of dose received
Interval 40.2 to 103.6
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline up to 2 yearsThe mean and median change in mutation concentration for each prespecified gene, and provide the corresponding 95% confidence intervals will be estimated. Cox proportional hazards models will be applied to explore the predictive value of pretreatment mutation status for cetuximab sensitivity and resistance, using PFS and OS as the outcome variables.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline up to 2 yearsScatter plots and box plots will be used to illustrate such change.
Outcome measures
Outcome data not reported
Adverse Events
Arm I (Irinotecan, Cetuximab, Bevacizumab)
Arm II (Irinotecan, Cetuximab, Placebo)
Serious adverse events
| Measure |
Arm I (Irinotecan, Cetuximab, Bevacizumab)
n=19 participants at risk
Patients receive 500 mg/m\^2 cetuximab IV over 90-120 minutes, 5 mg/kg bevacizumab IV over 30-90 minutes, and 180 mg/m\^2 irinotecan IV over 90 minutes on day 1. Cycles repeat every 14 days in the absence of disease progression or unacceptable toxicity.
|
Arm II (Irinotecan, Cetuximab, Placebo)
n=17 participants at risk
Patients receive 500 mg/m\^2 cetuximab IV over 90-120 minutes, 5 mg/kg placebo IV over 30-90 minutes, and 180 mg/m\^2 irinotecan IV over 90 minutes on day 1. Cycles repeat every 14 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
5.3%
1/19 • Number of events 1 • Up to 30 days from last dose of study treatment; Up to 51 months
|
11.8%
2/17 • Number of events 2 • Up to 30 days from last dose of study treatment; Up to 51 months
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Oth spec
|
0.00%
0/19 • Up to 30 days from last dose of study treatment; Up to 51 months
|
5.9%
1/17 • Number of events 1 • Up to 30 days from last dose of study treatment; Up to 51 months
|
|
Gastrointestinal disorders
Mucositis oral
|
5.3%
1/19 • Number of events 2 • Up to 30 days from last dose of study treatment; Up to 51 months
|
0.00%
0/17 • Up to 30 days from last dose of study treatment; Up to 51 months
|
|
Gastrointestinal disorders
Nausea
|
5.3%
1/19 • Number of events 1 • Up to 30 days from last dose of study treatment; Up to 51 months
|
5.9%
1/17 • Number of events 1 • Up to 30 days from last dose of study treatment; Up to 51 months
|
|
Gastrointestinal disorders
Vomiting
|
5.3%
1/19 • Number of events 1 • Up to 30 days from last dose of study treatment; Up to 51 months
|
11.8%
2/17 • Number of events 2 • Up to 30 days from last dose of study treatment; Up to 51 months
|
|
General disorders
Fever
|
0.00%
0/19 • Up to 30 days from last dose of study treatment; Up to 51 months
|
5.9%
1/17 • Number of events 1 • Up to 30 days from last dose of study treatment; Up to 51 months
|
|
Hepatobiliary disorders
Hepatobiliary disorders - Other, specify
|
0.00%
0/19 • Up to 30 days from last dose of study treatment; Up to 51 months
|
5.9%
1/17 • Number of events 1 • Up to 30 days from last dose of study treatment; Up to 51 months
|
|
Infections and infestations
Sepsis
|
5.3%
1/19 • Number of events 1 • Up to 30 days from last dose of study treatment; Up to 51 months
|
0.00%
0/17 • Up to 30 days from last dose of study treatment; Up to 51 months
|
|
Metabolism and nutrition disorders
Dehydration
|
10.5%
2/19 • Number of events 3 • Up to 30 days from last dose of study treatment; Up to 51 months
|
0.00%
0/17 • Up to 30 days from last dose of study treatment; Up to 51 months
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/19 • Up to 30 days from last dose of study treatment; Up to 51 months
|
5.9%
1/17 • Number of events 1 • Up to 30 days from last dose of study treatment; Up to 51 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.3%
1/19 • Number of events 1 • Up to 30 days from last dose of study treatment; Up to 51 months
|
5.9%
1/17 • Number of events 1 • Up to 30 days from last dose of study treatment; Up to 51 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, mal, uncpec - Oth spec
|
5.3%
1/19 • Number of events 1 • Up to 30 days from last dose of study treatment; Up to 51 months
|
0.00%
0/17 • Up to 30 days from last dose of study treatment; Up to 51 months
|
|
Renal and urinary disorders
Acute kidney injury
|
5.3%
1/19 • Number of events 1 • Up to 30 days from last dose of study treatment; Up to 51 months
|
0.00%
0/17 • Up to 30 days from last dose of study treatment; Up to 51 months
|
|
Vascular disorders
Hypotension
|
5.3%
1/19 • Number of events 1 • Up to 30 days from last dose of study treatment; Up to 51 months
|
0.00%
0/17 • Up to 30 days from last dose of study treatment; Up to 51 months
|
Other adverse events
| Measure |
Arm I (Irinotecan, Cetuximab, Bevacizumab)
n=19 participants at risk
Patients receive 500 mg/m\^2 cetuximab IV over 90-120 minutes, 5 mg/kg bevacizumab IV over 30-90 minutes, and 180 mg/m\^2 irinotecan IV over 90 minutes on day 1. Cycles repeat every 14 days in the absence of disease progression or unacceptable toxicity.
|
Arm II (Irinotecan, Cetuximab, Placebo)
n=17 participants at risk
Patients receive 500 mg/m\^2 cetuximab IV over 90-120 minutes, 5 mg/kg placebo IV over 30-90 minutes, and 180 mg/m\^2 irinotecan IV over 90 minutes on day 1. Cycles repeat every 14 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/19 • Up to 30 days from last dose of study treatment; Up to 51 months
|
5.9%
1/17 • Number of events 2 • Up to 30 days from last dose of study treatment; Up to 51 months
|
|
Gastrointestinal disorders
Constipation
|
5.3%
1/19 • Number of events 1 • Up to 30 days from last dose of study treatment; Up to 51 months
|
0.00%
0/17 • Up to 30 days from last dose of study treatment; Up to 51 months
|
|
Gastrointestinal disorders
Diarrhea
|
78.9%
15/19 • Number of events 164 • Up to 30 days from last dose of study treatment; Up to 51 months
|
70.6%
12/17 • Number of events 48 • Up to 30 days from last dose of study treatment; Up to 51 months
|
|
Gastrointestinal disorders
Mucositis oral
|
0.00%
0/19 • Up to 30 days from last dose of study treatment; Up to 51 months
|
5.9%
1/17 • Number of events 4 • Up to 30 days from last dose of study treatment; Up to 51 months
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/19 • Up to 30 days from last dose of study treatment; Up to 51 months
|
5.9%
1/17 • Number of events 1 • Up to 30 days from last dose of study treatment; Up to 51 months
|
|
Gastrointestinal disorders
Vomiting
|
5.3%
1/19 • Number of events 1 • Up to 30 days from last dose of study treatment; Up to 51 months
|
5.9%
1/17 • Number of events 1 • Up to 30 days from last dose of study treatment; Up to 51 months
|
|
General disorders
Fatigue
|
0.00%
0/19 • Up to 30 days from last dose of study treatment; Up to 51 months
|
5.9%
1/17 • Number of events 1 • Up to 30 days from last dose of study treatment; Up to 51 months
|
|
Infections and infestations
Upper respiratory infection
|
0.00%
0/19 • Up to 30 days from last dose of study treatment; Up to 51 months
|
5.9%
1/17 • Number of events 1 • Up to 30 days from last dose of study treatment; Up to 51 months
|
|
Investigations
Neutrophil count decreased
|
47.4%
9/19 • Number of events 62 • Up to 30 days from last dose of study treatment; Up to 51 months
|
41.2%
7/17 • Number of events 23 • Up to 30 days from last dose of study treatment; Up to 51 months
|
|
Investigations
Platelet count decreased
|
26.3%
5/19 • Number of events 51 • Up to 30 days from last dose of study treatment; Up to 51 months
|
29.4%
5/17 • Number of events 18 • Up to 30 days from last dose of study treatment; Up to 51 months
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/19 • Up to 30 days from last dose of study treatment; Up to 51 months
|
5.9%
1/17 • Number of events 1 • Up to 30 days from last dose of study treatment; Up to 51 months
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
78.9%
15/19 • Number of events 173 • Up to 30 days from last dose of study treatment; Up to 51 months
|
70.6%
12/17 • Number of events 61 • Up to 30 days from last dose of study treatment; Up to 51 months
|
|
Renal and urinary disorders
Acute kidney injury
|
5.3%
1/19 • Number of events 1 • Up to 30 days from last dose of study treatment; Up to 51 months
|
0.00%
0/17 • Up to 30 days from last dose of study treatment; Up to 51 months
|
|
Renal and urinary disorders
Proteinuria
|
10.5%
2/19 • Number of events 14 • Up to 30 days from last dose of study treatment; Up to 51 months
|
0.00%
0/17 • Up to 30 days from last dose of study treatment; Up to 51 months
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
0.00%
0/19 • Up to 30 days from last dose of study treatment; Up to 51 months
|
5.9%
1/17 • Number of events 1 • Up to 30 days from last dose of study treatment; Up to 51 months
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
0.00%
0/19 • Up to 30 days from last dose of study treatment; Up to 51 months
|
5.9%
1/17 • Number of events 1 • Up to 30 days from last dose of study treatment; Up to 51 months
|
|
Respiratory, thoracic and mediastinal disorders
Resp, thoracic, mediastinal - Oth spec
|
0.00%
0/19 • Up to 30 days from last dose of study treatment; Up to 51 months
|
5.9%
1/17 • Number of events 1 • Up to 30 days from last dose of study treatment; Up to 51 months
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/19 • Up to 30 days from last dose of study treatment; Up to 51 months
|
5.9%
1/17 • Number of events 5 • Up to 30 days from last dose of study treatment; Up to 51 months
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/19 • Up to 30 days from last dose of study treatment; Up to 51 months
|
5.9%
1/17 • Number of events 6 • Up to 30 days from last dose of study treatment; Up to 51 months
|
|
Skin and subcutaneous tissue disorders
Nail loss
|
0.00%
0/19 • Up to 30 days from last dose of study treatment; Up to 51 months
|
5.9%
1/17 • Number of events 1 • Up to 30 days from last dose of study treatment; Up to 51 months
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
89.5%
17/19 • Number of events 213 • Up to 30 days from last dose of study treatment; Up to 51 months
|
88.2%
15/17 • Number of events 92 • Up to 30 days from last dose of study treatment; Up to 51 months
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
73.7%
14/19 • Number of events 186 • Up to 30 days from last dose of study treatment; Up to 51 months
|
88.2%
15/17 • Number of events 96 • Up to 30 days from last dose of study treatment; Up to 51 months
|
|
Vascular disorders
Hypertension
|
89.5%
17/19 • Number of events 193 • Up to 30 days from last dose of study treatment; Up to 51 months
|
76.5%
13/17 • Number of events 112 • Up to 30 days from last dose of study treatment; Up to 51 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place