Trial Outcomes & Findings for Aflibercept and FOLFOX6 Treatment for Previously Untreated Stage IV Colorectal Cancer (NCT NCT01652196)
NCT ID: NCT01652196
Last Updated: 2025-02-05
Results Overview
Assuming that the number of treatment successes (alive and progression-free) is binomially distributed, proportion estimates along with their corresponding exact 95% confidence intervals will be calculated.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
56 participants
Primary outcome timeframe
At 15 months from initiation of therapy
Results posted on
2025-02-05
Participant Flow
Participant milestones
| Measure |
Aflibercept (Combination Chemotherapy)
Patients receive aflibercept and fluorouracil and then continuously over 46 hours on days 1 and 15.If leucovorin is not available due to drug shortages the regimen should be administered with the leucovorin omitted. Correlative Studies are required to be available before enrolling on the study. A fresh biopsy is only required if there is insufficient material for analysis. Repeat tumor biopsies after 8 weeks of therapy are optional and will only be performed at the Ohio State University Medical Center.DCE MRI (dynamic contrast-enhanced magnetic resonance imaging)images at weeks 0, and after 8 weeks +/- 1 week of treatment(after Cycle 2). 18FDG-PET is a functional imaging technique that relies on tumor uptake of radiolabeled tracer 18 fluorodeoxyglucose (18FDG).FDG-PET is a widely-used imaging modality in the detection and monitoring of a variety of metastatic cancers,including colorectal cancer (99-102).
aflibercept: 4 mg/kg as a 1-hour IV(intervenous) infusion
oxaliplatin: 85 mg/m2 IV infused over 2 hours
leucovorin: 200 mg/m2 (Or levoleucovorin 100 mg/m2. If leucovorin is not available due to drug shortages the regimen should be administered with the leucovorin omitted) IV over 2 hours. Alternatively, leucovorin may be administered (via separate infusion lines) concurrently with oxaliplatin
fluorouracil: 400 mg/m2 IV bolus over 5-15 minutes, then 2400 mg/m2 continuous IV infusion over 46 hours.
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|---|---|
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Overall Study
STARTED
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56
|
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Overall Study
COMPLETED
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56
|
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Aflibercept and FOLFOX6 Treatment for Previously Untreated Stage IV Colorectal Cancer
Baseline characteristics by cohort
| Measure |
Aflibercept (Combination Chemotherapy)
n=56 Participants
Patients receive aflibercept and fluorouracil and then continuously over 46 hours on days 1 and 15.If leucovorin is not available due to drug shortages the regimen should be administered with the leucovorin omitted. Correlative Studies are required to be available before enrolling on the study. A fresh biopsy is only required if there is insufficient material for analysis. Repeat tumor biopsies after 8 weeks of therapy are optional and will only be performed at the Ohio State University Medical Center.DCE MRI (dynamic contrast-enhanced magnetic resonance imaging)images at weeks 0, and after 8 weeks +/- 1 week of treatment(after Cycle 2). 18FDG-PET is a functional imaging technique that relies on tumor uptake of radiolabeled tracer 18 fluorodeoxyglucose (18FDG).FDG-PET is a widely-used imaging modality in the detection and monitoring of a variety of metastatic cancers,including colorectal cancer (99-102).
aflibercept: 4 mg/kg as a 1-hour IV(intervenous) infusion oxaliplatin: 85 mg/m2 IV infused over 2 hours leucovorin: 200 mg/m2 (Or levoleucovorin 100 mg/m2. If leucovorin is not available due to drug shortages the regimen should be administered with the leucovorin omitted) IV over 2 hours. Alternatively, leucovorin may be administered (via separate infusion lines) concurrently with oxaliplatin fluorouracil: 400 mg/m2 IV bolus over 5-15 minutes, then 2400 mg/m2 continuous IV infusion over 46 hours.
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|---|---|
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Age, Continuous
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56.9 years
n=5 Participants
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Sex: Female, Male
Female
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27 Participants
n=5 Participants
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Sex: Female, Male
Male
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29 Participants
n=5 Participants
|
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Asian
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2 Participants
n=5 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Black or African American
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8 Participants
n=5 Participants
|
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Race (NIH/OMB)
White
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43 Participants
n=5 Participants
|
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Race (NIH/OMB)
More than one race
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0 Participants
n=5 Participants
|
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Race (NIH/OMB)
Unknown or Not Reported
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3 Participants
n=5 Participants
|
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Region of Enrollment
United States
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56 participants
n=5 Participants
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PRIMARY outcome
Timeframe: At 15 months from initiation of therapyAssuming that the number of treatment successes (alive and progression-free) is binomially distributed, proportion estimates along with their corresponding exact 95% confidence intervals will be calculated.
Outcome measures
| Measure |
Aflibercept (Combination Chemotherapy)
n=56 Participants
Patients receive aflibercept and fluorouracil and then continuously over 46 hours on days 1 and 15.If leucovorin is not available due to drug shortages the regimen should be administered with the leucovorin omitted. Correlative Studies are required to be available before enrolling on the study. A fresh biopsy is only required if there is insufficient material for analysis. Repeat tumor biopsies after 8 weeks of therapy are optional and will only be performed at the Ohio State University Medical Center.DCE MRI (dynamic contrast-enhanced magnetic resonance imaging)images at weeks 0, and after 8 weeks +/- 1 week of treatment(after Cycle 2). 18FDG-PET is a functional imaging technique that relies on tumor uptake of radiolabeled tracer 18 fluorodeoxyglucose (18FDG).FDG-PET is a widely-used imaging modality in the detection and monitoring of a variety of metastatic cancers,including colorectal cancer (99-102).
aflibercept: 4 mg/kg as a 1-hour IV(intervenous) infusion
oxaliplatin: 85 mg/m2 IV infused over 2 hours
leucovorin: 200 mg/m2 (Or levoleucovorin 100 mg/m2. If leucovorin is not available due to drug shortages the regimen should be administered with the leucovorin omitted) IV over 2 hours. Alternatively, leucovorin may be administered (via separate infusion lines) concurrently with oxaliplatin
fluorouracil: 400 mg/m2 IV bolus over 5-15 minutes, then 2400 mg/m2 continuous IV infusion over 46 hours.
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Proportion of Patients Alive and Progression-free at 15 Months
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.482 proportion of participants
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SECONDARY outcome
Timeframe: Up to 4 weeks post-treatmentSummarized as a proportion with corresponding 95% confidence interval.
Outcome measures
| Measure |
Aflibercept (Combination Chemotherapy)
n=56 Participants
Patients receive aflibercept and fluorouracil and then continuously over 46 hours on days 1 and 15.If leucovorin is not available due to drug shortages the regimen should be administered with the leucovorin omitted. Correlative Studies are required to be available before enrolling on the study. A fresh biopsy is only required if there is insufficient material for analysis. Repeat tumor biopsies after 8 weeks of therapy are optional and will only be performed at the Ohio State University Medical Center.DCE MRI (dynamic contrast-enhanced magnetic resonance imaging)images at weeks 0, and after 8 weeks +/- 1 week of treatment(after Cycle 2). 18FDG-PET is a functional imaging technique that relies on tumor uptake of radiolabeled tracer 18 fluorodeoxyglucose (18FDG).FDG-PET is a widely-used imaging modality in the detection and monitoring of a variety of metastatic cancers,including colorectal cancer (99-102).
aflibercept: 4 mg/kg as a 1-hour IV(intervenous) infusion
oxaliplatin: 85 mg/m2 IV infused over 2 hours
leucovorin: 200 mg/m2 (Or levoleucovorin 100 mg/m2. If leucovorin is not available due to drug shortages the regimen should be administered with the leucovorin omitted) IV over 2 hours. Alternatively, leucovorin may be administered (via separate infusion lines) concurrently with oxaliplatin
fluorouracil: 400 mg/m2 IV bolus over 5-15 minutes, then 2400 mg/m2 continuous IV infusion over 46 hours.
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Objective Response Rate (ORR) Defined as the Proportion of Patients Who Achieve a PR or CR Based on RECIST 1.1 Criteria Divided by the Total Number of Evaluable Patients
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0.446 proportion of participants
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SECONDARY outcome
Timeframe: Up to 4 weeks post-treatmentSummarized as a proportion with corresponding 95% confidence interval.
Outcome measures
| Measure |
Aflibercept (Combination Chemotherapy)
n=56 Participants
Patients receive aflibercept and fluorouracil and then continuously over 46 hours on days 1 and 15.If leucovorin is not available due to drug shortages the regimen should be administered with the leucovorin omitted. Correlative Studies are required to be available before enrolling on the study. A fresh biopsy is only required if there is insufficient material for analysis. Repeat tumor biopsies after 8 weeks of therapy are optional and will only be performed at the Ohio State University Medical Center.DCE MRI (dynamic contrast-enhanced magnetic resonance imaging)images at weeks 0, and after 8 weeks +/- 1 week of treatment(after Cycle 2). 18FDG-PET is a functional imaging technique that relies on tumor uptake of radiolabeled tracer 18 fluorodeoxyglucose (18FDG).FDG-PET is a widely-used imaging modality in the detection and monitoring of a variety of metastatic cancers,including colorectal cancer (99-102).
aflibercept: 4 mg/kg as a 1-hour IV(intervenous) infusion
oxaliplatin: 85 mg/m2 IV infused over 2 hours
leucovorin: 200 mg/m2 (Or levoleucovorin 100 mg/m2. If leucovorin is not available due to drug shortages the regimen should be administered with the leucovorin omitted) IV over 2 hours. Alternatively, leucovorin may be administered (via separate infusion lines) concurrently with oxaliplatin
fluorouracil: 400 mg/m2 IV bolus over 5-15 minutes, then 2400 mg/m2 continuous IV infusion over 46 hours.
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|---|---|
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Percentage of Patients Able to Undergo Surgery
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5.36 percentage of participants
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SECONDARY outcome
Timeframe: From study entry to the time of progressive disease and/or death, assessed up to 4 weeks post-treatment, assessed up to 4 years and 2 monthsWill be evaluated using the methods of Kaplan and Meier.
Outcome measures
| Measure |
Aflibercept (Combination Chemotherapy)
n=56 Participants
Patients receive aflibercept and fluorouracil and then continuously over 46 hours on days 1 and 15.If leucovorin is not available due to drug shortages the regimen should be administered with the leucovorin omitted. Correlative Studies are required to be available before enrolling on the study. A fresh biopsy is only required if there is insufficient material for analysis. Repeat tumor biopsies after 8 weeks of therapy are optional and will only be performed at the Ohio State University Medical Center.DCE MRI (dynamic contrast-enhanced magnetic resonance imaging)images at weeks 0, and after 8 weeks +/- 1 week of treatment(after Cycle 2). 18FDG-PET is a functional imaging technique that relies on tumor uptake of radiolabeled tracer 18 fluorodeoxyglucose (18FDG).FDG-PET is a widely-used imaging modality in the detection and monitoring of a variety of metastatic cancers,including colorectal cancer (99-102).
aflibercept: 4 mg/kg as a 1-hour IV(intervenous) infusion
oxaliplatin: 85 mg/m2 IV infused over 2 hours
leucovorin: 200 mg/m2 (Or levoleucovorin 100 mg/m2. If leucovorin is not available due to drug shortages the regimen should be administered with the leucovorin omitted) IV over 2 hours. Alternatively, leucovorin may be administered (via separate infusion lines) concurrently with oxaliplatin
fluorouracil: 400 mg/m2 IV bolus over 5-15 minutes, then 2400 mg/m2 continuous IV infusion over 46 hours.
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|---|---|
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Progression Free Survival (PFS)
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7.82 months
Interval 7.36 to 10.71
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SECONDARY outcome
Timeframe: From study entry to time of death due to any cause, assessed up to 4 weeks post-treatmentWill be evaluated using the methods of Kaplan and Meier.
Outcome measures
| Measure |
Aflibercept (Combination Chemotherapy)
n=56 Participants
Patients receive aflibercept and fluorouracil and then continuously over 46 hours on days 1 and 15.If leucovorin is not available due to drug shortages the regimen should be administered with the leucovorin omitted. Correlative Studies are required to be available before enrolling on the study. A fresh biopsy is only required if there is insufficient material for analysis. Repeat tumor biopsies after 8 weeks of therapy are optional and will only be performed at the Ohio State University Medical Center.DCE MRI (dynamic contrast-enhanced magnetic resonance imaging)images at weeks 0, and after 8 weeks +/- 1 week of treatment(after Cycle 2). 18FDG-PET is a functional imaging technique that relies on tumor uptake of radiolabeled tracer 18 fluorodeoxyglucose (18FDG).FDG-PET is a widely-used imaging modality in the detection and monitoring of a variety of metastatic cancers,including colorectal cancer (99-102).
aflibercept: 4 mg/kg as a 1-hour IV(intervenous) infusion
oxaliplatin: 85 mg/m2 IV infused over 2 hours
leucovorin: 200 mg/m2 (Or levoleucovorin 100 mg/m2. If leucovorin is not available due to drug shortages the regimen should be administered with the leucovorin omitted) IV over 2 hours. Alternatively, leucovorin may be administered (via separate infusion lines) concurrently with oxaliplatin
fluorouracil: 400 mg/m2 IV bolus over 5-15 minutes, then 2400 mg/m2 continuous IV infusion over 46 hours.
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Overall Survival
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19.68 months
Interval 16.23 to 25.79
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SECONDARY outcome
Timeframe: Up to 4 weeks post-treatmentOutcome measures
| Measure |
Aflibercept (Combination Chemotherapy)
n=56 Participants
Patients receive aflibercept and fluorouracil and then continuously over 46 hours on days 1 and 15.If leucovorin is not available due to drug shortages the regimen should be administered with the leucovorin omitted. Correlative Studies are required to be available before enrolling on the study. A fresh biopsy is only required if there is insufficient material for analysis. Repeat tumor biopsies after 8 weeks of therapy are optional and will only be performed at the Ohio State University Medical Center.DCE MRI (dynamic contrast-enhanced magnetic resonance imaging)images at weeks 0, and after 8 weeks +/- 1 week of treatment(after Cycle 2). 18FDG-PET is a functional imaging technique that relies on tumor uptake of radiolabeled tracer 18 fluorodeoxyglucose (18FDG).FDG-PET is a widely-used imaging modality in the detection and monitoring of a variety of metastatic cancers,including colorectal cancer (99-102).
aflibercept: 4 mg/kg as a 1-hour IV(intervenous) infusion
oxaliplatin: 85 mg/m2 IV infused over 2 hours
leucovorin: 200 mg/m2 (Or levoleucovorin 100 mg/m2. If leucovorin is not available due to drug shortages the regimen should be administered with the leucovorin omitted) IV over 2 hours. Alternatively, leucovorin may be administered (via separate infusion lines) concurrently with oxaliplatin
fluorouracil: 400 mg/m2 IV bolus over 5-15 minutes, then 2400 mg/m2 continuous IV infusion over 46 hours.
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Incidence of Severe (Grade 3+) Adverse Events or Toxicities, Assessed Using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0
Hypertension
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33.9 percentage of patients
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Incidence of Severe (Grade 3+) Adverse Events or Toxicities, Assessed Using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0
Neutropenia
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25 percentage of patients
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Incidence of Severe (Grade 3+) Adverse Events or Toxicities, Assessed Using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0
Thromboembolic events
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12.5 percentage of patients
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Incidence of Severe (Grade 3+) Adverse Events or Toxicities, Assessed Using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0
Hypertriglyceridemia
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10.7 percentage of patients
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SECONDARY outcome
Timeframe: Up to 4 weeks post-treatmentOutcome measures
| Measure |
Aflibercept (Combination Chemotherapy)
n=56 Participants
Patients receive aflibercept and fluorouracil and then continuously over 46 hours on days 1 and 15.If leucovorin is not available due to drug shortages the regimen should be administered with the leucovorin omitted. Correlative Studies are required to be available before enrolling on the study. A fresh biopsy is only required if there is insufficient material for analysis. Repeat tumor biopsies after 8 weeks of therapy are optional and will only be performed at the Ohio State University Medical Center.DCE MRI (dynamic contrast-enhanced magnetic resonance imaging)images at weeks 0, and after 8 weeks +/- 1 week of treatment(after Cycle 2). 18FDG-PET is a functional imaging technique that relies on tumor uptake of radiolabeled tracer 18 fluorodeoxyglucose (18FDG).FDG-PET is a widely-used imaging modality in the detection and monitoring of a variety of metastatic cancers,including colorectal cancer (99-102).
aflibercept: 4 mg/kg as a 1-hour IV(intervenous) infusion
oxaliplatin: 85 mg/m2 IV infused over 2 hours
leucovorin: 200 mg/m2 (Or levoleucovorin 100 mg/m2. If leucovorin is not available due to drug shortages the regimen should be administered with the leucovorin omitted) IV over 2 hours. Alternatively, leucovorin may be administered (via separate infusion lines) concurrently with oxaliplatin
fluorouracil: 400 mg/m2 IV bolus over 5-15 minutes, then 2400 mg/m2 continuous IV infusion over 46 hours.
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|---|---|
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Tolerability in Terms of Number of Patients Who Require Dose Modifications and/or Dose Delays
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50 Participants
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SECONDARY outcome
Timeframe: Up to 4 weeks post-treatmentOutcome measures
| Measure |
Aflibercept (Combination Chemotherapy)
n=56 Participants
Patients receive aflibercept and fluorouracil and then continuously over 46 hours on days 1 and 15.If leucovorin is not available due to drug shortages the regimen should be administered with the leucovorin omitted. Correlative Studies are required to be available before enrolling on the study. A fresh biopsy is only required if there is insufficient material for analysis. Repeat tumor biopsies after 8 weeks of therapy are optional and will only be performed at the Ohio State University Medical Center.DCE MRI (dynamic contrast-enhanced magnetic resonance imaging)images at weeks 0, and after 8 weeks +/- 1 week of treatment(after Cycle 2). 18FDG-PET is a functional imaging technique that relies on tumor uptake of radiolabeled tracer 18 fluorodeoxyglucose (18FDG).FDG-PET is a widely-used imaging modality in the detection and monitoring of a variety of metastatic cancers,including colorectal cancer (99-102).
aflibercept: 4 mg/kg as a 1-hour IV(intervenous) infusion
oxaliplatin: 85 mg/m2 IV infused over 2 hours
leucovorin: 200 mg/m2 (Or levoleucovorin 100 mg/m2. If leucovorin is not available due to drug shortages the regimen should be administered with the leucovorin omitted) IV over 2 hours. Alternatively, leucovorin may be administered (via separate infusion lines) concurrently with oxaliplatin
fluorouracil: 400 mg/m2 IV bolus over 5-15 minutes, then 2400 mg/m2 continuous IV infusion over 46 hours.
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|---|---|
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Proportion of Patients Who go Off Treatment Due to Adverse Reactions or Even Those Who Refuse Further Treatment for Lesser Toxicities That Inhibit Their Willingness to Continue Participation on the Trial
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2 Participants
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Adverse Events
Aflibercept (Combination Chemotherapy)
Serious events: 7 serious events
Other events: 56 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Aflibercept (Combination Chemotherapy)
n=56 participants at risk
Patients receive aflibercept and fluorouracil and then continuously over 46 hours on days 1 and 15.If leucovorin is not available due to drug shortages the regimen should be administered with the leucovorin omitted. Correlative Studies are required to be available before enrolling on the study. A fresh biopsy is only required if there is insufficient material for analysis. Repeat tumor biopsies after 8 weeks of therapy are optional and will only be performed at the Ohio State University Medical Center.DCE MRI (dynamic contrast-enhanced magnetic resonance imaging)images at weeks 0, and after 8 weeks +/- 1 week of treatment(after Cycle 2). 18FDG-PET is a functional imaging technique that relies on tumor uptake of radiolabeled tracer 18 fluorodeoxyglucose (18FDG).FDG-PET is a widely-used imaging modality in the detection and monitoring of a variety of metastatic cancers,including colorectal cancer (99-102).
aflibercept: 4 mg/kg as a 1-hour IV(intervenous) infusion oxaliplatin: 85 mg/m2 IV infused over 2 hours leucovorin: 200 mg/m2 (Or levoleucovorin 100 mg/m2. If leucovorin is not available due to drug shortages the regimen should be administered with the leucovorin omitted) IV over 2 hours. Alternatively, leucovorin may be administered (via separate infusion lines) concurrently with oxaliplatin fluorouracil: 400 mg/m2 IV bolus over 5-15 minutes, then 2400 mg/m2 continuous IV infusion over 46 hours.
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|---|---|
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Vascular disorders
Hypertension
|
7.1%
4/56 • Number of events 4 • Adverse Events were collected and graded for patients from start of study until study completion up to an average of 4 years.
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Injury, poisoning and procedural complications
Infusion related reaction
|
1.8%
1/56 • Number of events 1 • Adverse Events were collected and graded for patients from start of study until study completion up to an average of 4 years.
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Gastrointestinal disorders
Nausea
|
1.8%
1/56 • Number of events 1 • Adverse Events were collected and graded for patients from start of study until study completion up to an average of 4 years.
|
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General disorders
Non-Cardiac Chest Pain
|
3.6%
2/56 • Number of events 2 • Adverse Events were collected and graded for patients from start of study until study completion up to an average of 4 years.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia
|
1.8%
1/56 • Number of events 1 • Adverse Events were collected and graded for patients from start of study until study completion up to an average of 4 years.
|
|
Cardiac disorders
Pericardial effusion
|
1.8%
1/56 • Number of events 1 • Adverse Events were collected and graded for patients from start of study until study completion up to an average of 4 years.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.8%
1/56 • Number of events 1 • Adverse Events were collected and graded for patients from start of study until study completion up to an average of 4 years.
|
|
Vascular disorders
Thromboembolic event
|
12.5%
7/56 • Number of events 7 • Adverse Events were collected and graded for patients from start of study until study completion up to an average of 4 years.
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
1.8%
1/56 • Number of events 1 • Adverse Events were collected and graded for patients from start of study until study completion up to an average of 4 years.
|
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Gastrointestinal disorders
Vomiting
|
1.8%
1/56 • Number of events 1 • Adverse Events were collected and graded for patients from start of study until study completion up to an average of 4 years.
|
|
Injury, poisoning and procedural complications
Wound complication
|
1.8%
1/56 • Number of events 1 • Adverse Events were collected and graded for patients from start of study until study completion up to an average of 4 years.
|
|
Gastrointestinal disorders
Abdominal Pain
|
3.6%
2/56 • Number of events 2 • Adverse Events were collected and graded for patients from start of study until study completion up to an average of 4 years.
|
|
Gastrointestinal disorders
Colonic perforation
|
1.8%
1/56 • Number of events 1 • Adverse Events were collected and graded for patients from start of study until study completion up to an average of 4 years.
|
|
Gastrointestinal disorders
Colonic obstruction
|
1.8%
1/56 • Number of events 1 • Adverse Events were collected and graded for patients from start of study until study completion up to an average of 4 years.
|
|
Gastrointestinal disorders
Constipation
|
1.8%
1/56 • Number of events 1 • Adverse Events were collected and graded for patients from start of study until study completion up to an average of 4 years.
|
|
Gastrointestinal disorders
Diarrhea
|
1.8%
1/56 • Number of events 1 • Adverse Events were collected and graded for patients from start of study until study completion up to an average of 4 years.
|
|
Infections and infestations
Catheter related infection
|
1.8%
1/56 • Number of events 1 • Adverse Events were collected and graded for patients from start of study until study completion up to an average of 4 years.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
3.6%
2/56 • Number of events 2 • Adverse Events were collected and graded for patients from start of study until study completion up to an average of 4 years.
|
|
Gastrointestinal disorders
Ileal obststruction
|
1.8%
1/56 • Number of events 1 • Adverse Events were collected and graded for patients from start of study until study completion up to an average of 4 years.
|
|
General disorders
Fever
|
3.6%
2/56 • Number of events 2 • Adverse Events were collected and graded for patients from start of study until study completion up to an average of 4 years.
|
|
General disorders
Pain
|
1.8%
1/56 • Number of events 1 • Adverse Events were collected and graded for patients from start of study until study completion up to an average of 4 years.
|
|
Nervous system disorders
Syncope
|
1.8%
1/56 • Number of events 1 • Adverse Events were collected and graded for patients from start of study until study completion up to an average of 4 years.
|
|
Nervous system disorders
Headache
|
1.8%
1/56 • Number of events 1 • Adverse Events were collected and graded for patients from start of study until study completion up to an average of 4 years.
|
|
Renal and urinary disorders
Acute Kidney Injury
|
1.8%
1/56 • Number of events 1 • Adverse Events were collected and graded for patients from start of study until study completion up to an average of 4 years.
|
|
Investigations
Creatinine increased
|
1.8%
1/56 • Number of events 1 • Adverse Events were collected and graded for patients from start of study until study completion up to an average of 4 years.
|
|
Nervous system disorders
Dizziness
|
1.8%
1/56 • Number of events 1 • Adverse Events were collected and graded for patients from start of study until study completion up to an average of 4 years.
|
Other adverse events
| Measure |
Aflibercept (Combination Chemotherapy)
n=56 participants at risk
Patients receive aflibercept and fluorouracil and then continuously over 46 hours on days 1 and 15.If leucovorin is not available due to drug shortages the regimen should be administered with the leucovorin omitted. Correlative Studies are required to be available before enrolling on the study. A fresh biopsy is only required if there is insufficient material for analysis. Repeat tumor biopsies after 8 weeks of therapy are optional and will only be performed at the Ohio State University Medical Center.DCE MRI (dynamic contrast-enhanced magnetic resonance imaging)images at weeks 0, and after 8 weeks +/- 1 week of treatment(after Cycle 2). 18FDG-PET is a functional imaging technique that relies on tumor uptake of radiolabeled tracer 18 fluorodeoxyglucose (18FDG).FDG-PET is a widely-used imaging modality in the detection and monitoring of a variety of metastatic cancers,including colorectal cancer (99-102).
aflibercept: 4 mg/kg as a 1-hour IV(intervenous) infusion oxaliplatin: 85 mg/m2 IV infused over 2 hours leucovorin: 200 mg/m2 (Or levoleucovorin 100 mg/m2. If leucovorin is not available due to drug shortages the regimen should be administered with the leucovorin omitted) IV over 2 hours. Alternatively, leucovorin may be administered (via separate infusion lines) concurrently with oxaliplatin fluorouracil: 400 mg/m2 IV bolus over 5-15 minutes, then 2400 mg/m2 continuous IV infusion over 46 hours.
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
19.6%
11/56 • Number of events 11 • Adverse Events were collected and graded for patients from start of study until study completion up to an average of 4 years.
|
|
Investigations
Alanine aminotransferase increased
|
26.8%
15/56 • Number of events 15 • Adverse Events were collected and graded for patients from start of study until study completion up to an average of 4 years.
|
|
Investigations
Alkaline phosphatase increased
|
42.9%
24/56 • Number of events 24 • Adverse Events were collected and graded for patients from start of study until study completion up to an average of 4 years.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
5.4%
3/56 • Number of events 3 • Adverse Events were collected and graded for patients from start of study until study completion up to an average of 4 years.
|
|
Blood and lymphatic system disorders
Anemia
|
55.4%
31/56 • Number of events 31 • Adverse Events were collected and graded for patients from start of study until study completion up to an average of 4 years.
|
|
Metabolism and nutrition disorders
Anorexia
|
32.1%
18/56 • Number of events 18 • Adverse Events were collected and graded for patients from start of study until study completion up to an average of 4 years.
|
|
Psychiatric disorders
Anxiety
|
12.5%
7/56 • Number of events 7 • Adverse Events were collected and graded for patients from start of study until study completion up to an average of 4 years.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.4%
3/56 • Number of events 3 • Adverse Events were collected and graded for patients from start of study until study completion up to an average of 4 years.
|
|
Investigations
Aspartate aminotransferase increased
|
44.6%
25/56 • Number of events 25 • Adverse Events were collected and graded for patients from start of study until study completion up to an average of 4 years.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
17.9%
10/56 • Number of events 10 • Adverse Events were collected and graded for patients from start of study until study completion up to an average of 4 years.
|
|
Investigations
Blood bilirubin increased
|
14.3%
8/56 • Number of events 8 • Adverse Events were collected and graded for patients from start of study until study completion up to an average of 4 years.
|
|
Eye disorders
Blurred vision
|
10.7%
6/56 • Number of events 6 • Adverse Events were collected and graded for patients from start of study until study completion up to an average of 4 years.
|
|
General disorders
Chills
|
7.1%
4/56 • Number of events 4 • Adverse Events were collected and graded for patients from start of study until study completion up to an average of 4 years.
|
|
Investigations
Cholesterol high
|
37.5%
21/56 • Number of events 21 • Adverse Events were collected and graded for patients from start of study until study completion up to an average of 4 years.
|
|
Gastrointestinal disorders
Constipation
|
44.6%
25/56 • Number of events 25 • Adverse Events were collected and graded for patients from start of study until study completion up to an average of 4 years.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
12.5%
7/56 • Number of events 7 • Adverse Events were collected and graded for patients from start of study until study completion up to an average of 4 years.
|
|
Renal and urinary disorders
Creatinine increased
|
17.9%
10/56 • Number of events 10 • Adverse Events were collected and graded for patients from start of study until study completion up to an average of 4 years.
|
|
Metabolism and nutrition disorders
Dehydration
|
10.7%
6/56 • Number of events 6 • Adverse Events were collected and graded for patients from start of study until study completion up to an average of 4 years.
|
|
Psychiatric disorders
Depression
|
8.9%
5/56 • Number of events 5 • Adverse Events were collected and graded for patients from start of study until study completion up to an average of 4 years.
|
|
Gastrointestinal disorders
Diarrhea
|
55.4%
31/56 • Number of events 31 • Adverse Events were collected and graded for patients from start of study until study completion up to an average of 4 years.
|
|
Nervous system disorders
Dizziness
|
28.6%
16/56 • Number of events 16 • Adverse Events were collected and graded for patients from start of study until study completion up to an average of 4 years.
|
|
Gastrointestinal disorders
Dry mouth
|
5.4%
3/56 • Number of events 3 • Adverse Events were collected and graded for patients from start of study until study completion up to an average of 4 years.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
5.4%
3/56 • Number of events 3 • Adverse Events were collected and graded for patients from start of study until study completion up to an average of 4 years.
|
|
Nervous system disorders
Dysgeusia
|
19.6%
11/56 • Number of events 11 • Adverse Events were collected and graded for patients from start of study until study completion up to an average of 4 years.
|
|
Gastrointestinal disorders
Dyspepsia
|
7.1%
4/56 • Number of events 4 • Adverse Events were collected and graded for patients from start of study until study completion up to an average of 4 years.
|
|
Gastrointestinal disorders
Dyspnea
|
30.4%
17/56 • Number of events 17 • Adverse Events were collected and graded for patients from start of study until study completion up to an average of 4 years.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
19.6%
11/56 • Number of events 11 • Adverse Events were collected and graded for patients from start of study until study completion up to an average of 4 years.
|
|
General disorders
Fatigue
|
60.7%
34/56 • Number of events 34 • Adverse Events were collected and graded for patients from start of study until study completion up to an average of 4 years.
|
|
General disorders
Fever
|
5.4%
3/56 • Number of events 3 • Adverse Events were collected and graded for patients from start of study until study completion up to an average of 4 years.
|
|
Gastrointestinal disorders
Flatulence
|
5.4%
3/56 • Number of events 3 • Adverse Events were collected and graded for patients from start of study until study completion up to an average of 4 years.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
8.9%
5/56 • Number of events 5 • Adverse Events were collected and graded for patients from start of study until study completion up to an average of 4 years.
|
|
Nervous system disorders
Headache
|
28.6%
16/56 • Number of events 16 • Adverse Events were collected and graded for patients from start of study until study completion up to an average of 4 years.
|
|
Renal and urinary disorders
Hematuria
|
17.9%
10/56 • Number of events 10 • Adverse Events were collected and graded for patients from start of study until study completion up to an average of 4 years.
|
|
Gastrointestinal disorders
Hemorrhoids
|
5.4%
3/56 • Number of events 3 • Adverse Events were collected and graded for patients from start of study until study completion up to an average of 4 years.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
7.1%
4/56 • Number of events 4 • Adverse Events were collected and graded for patients from start of study until study completion up to an average of 4 years.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
19.6%
11/56 • Number of events 11 • Adverse Events were collected and graded for patients from start of study until study completion up to an average of 4 years.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
10.7%
6/56 • Number of events 6 • Adverse Events were collected and graded for patients from start of study until study completion up to an average of 4 years.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
41.1%
23/56 • Number of events 23 • Adverse Events were collected and graded for patients from start of study until study completion up to an average of 4 years.
|
|
Investigations
Hyperkalemia
|
12.5%
7/56 • Number of events 7 • Adverse Events were collected and graded for patients from start of study until study completion up to an average of 4 years.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
8.9%
5/56 • Number of events 5 • Adverse Events were collected and graded for patients from start of study until study completion up to an average of 4 years.
|
|
Vascular disorders
Hypertension
|
66.1%
37/56 • Number of events 37 • Adverse Events were collected and graded for patients from start of study until study completion up to an average of 4 years.
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
39.3%
22/56 • Number of events 22 • Adverse Events were collected and graded for patients from start of study until study completion up to an average of 4 years.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
35.7%
20/56 • Number of events 20 • Adverse Events were collected and graded for patients from start of study until study completion up to an average of 4 years.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
7.1%
4/56 • Number of events 4 • Adverse Events were collected and graded for patients from start of study until study completion up to an average of 4 years.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
7.1%
4/56 • Number of events 4 • Adverse Events were collected and graded for patients from start of study until study completion up to an average of 4 years.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
17.9%
10/56 • Number of events 10 • Adverse Events were collected and graded for patients from start of study until study completion up to an average of 4 years.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
5.4%
3/56 • Number of events 3 • Adverse Events were collected and graded for patients from start of study until study completion up to an average of 4 years.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
23.2%
13/56 • Number of events 13 • Adverse Events were collected and graded for patients from start of study until study completion up to an average of 4 years.
|
|
Vascular disorders
Hypotension
|
10.7%
6/56 • Number of events 6 • Adverse Events were collected and graded for patients from start of study until study completion up to an average of 4 years.
|
|
Psychiatric disorders
Insomnia
|
8.9%
5/56 • Number of events 5 • Adverse Events were collected and graded for patients from start of study until study completion up to an average of 4 years.
|
|
Investigations
Lymphocyte count decreased
|
39.3%
22/56 • Number of events 22 • Adverse Events were collected and graded for patients from start of study until study completion up to an average of 4 years.
|
|
Gastrointestinal disorders
Mucositis oral
|
55.4%
31/56 • Number of events 31 • Adverse Events were collected and graded for patients from start of study until study completion up to an average of 4 years.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
7.1%
4/56 • Number of events 4 • Adverse Events were collected and graded for patients from start of study until study completion up to an average of 4 years.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.4%
3/56 • Number of events 3 • Adverse Events were collected and graded for patients from start of study until study completion up to an average of 4 years.
|
|
Skin and subcutaneous tissue disorders
Nail discoloration
|
5.4%
3/56 • Number of events 3 • Adverse Events were collected and graded for patients from start of study until study completion up to an average of 4 years.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
7.1%
4/56 • Number of events 4 • Adverse Events were collected and graded for patients from start of study until study completion up to an average of 4 years.
|
|
Gastrointestinal disorders
Nausea
|
71.4%
40/56 • Number of events 40 • Adverse Events were collected and graded for patients from start of study until study completion up to an average of 4 years.
|
|
Nervous system disorders
Cold Sensitivity
|
7.1%
4/56 • Number of events 4 • Adverse Events were collected and graded for patients from start of study until study completion up to an average of 4 years.
|
|
Investigations
Neutrophil count decreased
|
50.0%
28/56 • Number of events 28 • Adverse Events were collected and graded for patients from start of study until study completion up to an average of 4 years.
|
|
General disorders
Non cardiac chest pain
|
10.7%
6/56 • Number of events 6 • Adverse Events were collected and graded for patients from start of study until study completion up to an average of 4 years.
|
|
Gastrointestinal disorders
Oral pain
|
8.9%
5/56 • Number of events 5 • Adverse Events were collected and graded for patients from start of study until study completion up to an average of 4 years.
|
|
General disorders
Pain
|
17.9%
10/56 • Number of events 10 • Adverse Events were collected and graded for patients from start of study until study completion up to an average of 4 years.
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
23.2%
13/56 • Number of events 13 • Adverse Events were collected and graded for patients from start of study until study completion up to an average of 4 years.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
33.9%
19/56 • Number of events 19 • Adverse Events were collected and graded for patients from start of study until study completion up to an average of 4 years.
|
|
Nervous system disorders
Paresthesia
|
25.0%
14/56 • Number of events 14 • Adverse Events were collected and graded for patients from start of study until study completion up to an average of 4 years.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
58.9%
33/56 • Number of events 33 • Adverse Events were collected and graded for patients from start of study until study completion up to an average of 4 years.
|
|
Investigations
Platelet count decreased
|
51.8%
29/56 • Number of events 29 • Adverse Events were collected and graded for patients from start of study until study completion up to an average of 4 years.
|
|
Renal and urinary disorders
Proteinuria
|
37.5%
21/56 • Number of events 21 • Adverse Events were collected and graded for patients from start of study until study completion up to an average of 4 years.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.4%
3/56 • Number of events 3 • Adverse Events were collected and graded for patients from start of study until study completion up to an average of 4 years.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
5.4%
3/56 • Number of events 3 • Adverse Events were collected and graded for patients from start of study until study completion up to an average of 4 years.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
17.9%
10/56 • Number of events 10 • Adverse Events were collected and graded for patients from start of study until study completion up to an average of 4 years.
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
5.4%
3/56 • Number of events 3 • Adverse Events were collected and graded for patients from start of study until study completion up to an average of 4 years.
|
|
Gastrointestinal disorders
Rectal pain
|
12.5%
7/56 • Number of events 7 • Adverse Events were collected and graded for patients from start of study until study completion up to an average of 4 years.
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify
|
8.9%
5/56 • Number of events 5 • Adverse Events were collected and graded for patients from start of study until study completion up to an average of 4 years.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
7.1%
4/56 • Number of events 4 • Adverse Events were collected and graded for patients from start of study until study completion up to an average of 4 years.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
19.6%
11/56 • Number of events 11 • Adverse Events were collected and graded for patients from start of study until study completion up to an average of 4 years.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
17.9%
10/56 • Number of events 10 • Adverse Events were collected and graded for patients from start of study until study completion up to an average of 4 years.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
8.9%
5/56 • Number of events 5 • Adverse Events were collected and graded for patients from start of study until study completion up to an average of 4 years.
|
|
Vascular disorders
Thromboembolic event
|
19.6%
11/56 • Number of events 11 • Adverse Events were collected and graded for patients from start of study until study completion up to an average of 4 years.
|
|
Nervous system disorders
Tremor
|
7.1%
4/56 • Number of events 4 • Adverse Events were collected and graded for patients from start of study until study completion up to an average of 4 years.
|
|
Infections and infestations
Upper respiratory infection
|
5.4%
3/56 • Number of events 3 • Adverse Events were collected and graded for patients from start of study until study completion up to an average of 4 years.
|
|
Infections and infestations
Urinary tract infection
|
14.3%
8/56 • Number of events 8 • Adverse Events were collected and graded for patients from start of study until study completion up to an average of 4 years.
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
7.1%
4/56 • Number of events 4 • Adverse Events were collected and graded for patients from start of study until study completion up to an average of 4 years.
|
|
Gastrointestinal disorders
Vomiting
|
53.6%
30/56 • Number of events 30 • Adverse Events were collected and graded for patients from start of study until study completion up to an average of 4 years.
|
|
Investigations
Weight loss
|
28.6%
16/56 • Number of events 16 • Adverse Events were collected and graded for patients from start of study until study completion up to an average of 4 years.
|
|
Investigations
White blood cell decreased
|
42.9%
24/56 • Number of events 24 • Adverse Events were collected and graded for patients from start of study until study completion up to an average of 4 years.
|
Additional Information
Dr. John Hays
The Ohio State University Comprehensive Cancer Center
Phone: 614-293-6529
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place