Trial Outcomes & Findings for Optimization of Bevacizumab Scheduling With Chemotherapy for Metastatic Colorectal Cancer (NCT NCT01718873)
NCT ID: NCT01718873
Last Updated: 2023-04-12
Results Overview
Objective response rate (ORR), according to Response Evaluation Criteria in Solid Tumors (RECIST),version 1.1, was the primary end point and was defined as the number of complete plus partial responses divided by the number of enrolled patients. Per RECIST v 1.1 for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
230 participants
Primary outcome timeframe
Objective response was assessed by computed tomographic scan or other appropriate imaging at weeks 12 and 24 from randomization, and every 3 months thereafter, assessed up to 90 months.
Results posted on
2023-04-12
Participant Flow
Participant milestones
| Measure |
Bevacizumab Before Chemotherapy
Bevacizumab administered 4 days before each cycle of chemotherapy containing oxaliplatin (mFOLFOX-6 / mOXXEL)
Bevacizumab: 5 mg/kg every 2 weeks for up to 24 weeks. After 24 weeks, those patients without disease progression will receive bevacizumab 7.5 mg/kg every 3 weeks until progression of disease or unacceptable toxicity.
Oxaliplatin: 85mg/m2 IV every 2 weeks for up to 24 weeks
levo-folinic acid: 200 mg/m2 IV before 5-fluorouracil infusion, every 2 weeks up to 24 weeks
5-fluorouracil: 400 mg/m2 IV bolus followed by 2400 mg/m2 IV infusion over 46 hours, every 2 weeks for up to 24 weeks (given in mFOLFOX-6 schedule)
Capecitabine: 1000mg/m2 by mouth, twice a day for 10 days, every 2 weeks for up to 24 weeks(given in mOXXEL schedule)
|
Bevacizumab With Chemotherapy
Bevacizumab administered on the first day of each cycle of chemotherapy containing oxaliplatin (mFOLFOX-6 / mOXXEL)
Bevacizumab: 5 mg/kg every 2 weeks for up to 24 weeks. After 24 weeks, those patients without disease progression will receive bevacizumab 7.5 mg/kg every 3 weeks until progression of disease or unacceptable toxicity.
Oxaliplatin: 85mg/m2 IV every 2 weeks for up to 24 weeks
levo-folinic acid: 200 mg/m2 IV before 5-fluorouracil infusion, every 2 weeks up to 24 weeks
5-fluorouracil: 400 mg/m2 IV bolus followed by 2400 mg/m2 IV infusion over 46 hours, every 2 weeks for up to 24 weeks (given in mFOLFOX-6 schedule)
Capecitabine: 1000mg/m2 by mouth, twice a day for 10 days, every 2 weeks for up to 24 weeks(given in mOXXEL schedule)
|
|---|---|---|
|
Overall Study
STARTED
|
115
|
115
|
|
Overall Study
COMPLETED
|
115
|
115
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Optimization of Bevacizumab Scheduling With Chemotherapy for Metastatic Colorectal Cancer
Baseline characteristics by cohort
| Measure |
Bevacizumab Before Chemotherapy
n=115 Participants
Bevacizumab administered 4 days before each cycle of chemotherapy containing oxaliplatin (mFOLFOX-6 / mOXXEL)
Bevacizumab: 5 mg/kg every 2 weeks for up to 24 weeks. After 24 weeks, those patients without disease progression will receive bevacizumab 7.5 mg/kg every 3 weeks until progression of disease or unacceptable toxicity.
Oxaliplatin: 85mg/m2 IV every 2 weeks for up to 24 weeks
levo-folinic acid: 200 mg/m2 IV before 5-fluorouracil infusion, every 2 weeks up to 24 weeks
5-fluorouracil: 400 mg/m2 IV bolus followed by 2400 mg/m2 IV infusion over 46 hours, every 2 weeks for up to 24 weeks (given in mFOLFOX-6 schedule)
Capecitabine: 1000mg/m2 by mouth, twice a day for 10 days, every 2 weeks for up to 24 weeks(given in mOXXEL schedule)
|
Bevacizumab With Chemotherapy
n=115 Participants
Bevacizumab administered on the first day of each cycle of chemotherapy containing oxaliplatin (mFOLFOX-6 / mOXXEL)
Bevacizumab: 5 mg/kg every 2 weeks for up to 24 weeks. After 24 weeks, those patients without disease progression will receive bevacizumab 7.5 mg/kg every 3 weeks until progression of disease or unacceptable toxicity.
Oxaliplatin: 85mg/m2 IV every 2 weeks for up to 24 weeks
levo-folinic acid: 200 mg/m2 IV before 5-fluorouracil infusion, every 2 weeks up to 24 weeks
5-fluorouracil: 400 mg/m2 IV bolus followed by 2400 mg/m2 IV infusion over 46 hours, every 2 weeks for up to 24 weeks (given in mFOLFOX-6 schedule)
Capecitabine: 1000mg/m2 by mouth, twice a day for 10 days, every 2 weeks for up to 24 weeks(given in mOXXEL schedule)
|
Total
n=230 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61 years
n=5 Participants
|
63 years
n=7 Participants
|
62.3 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
46 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
94 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
69 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
136 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
115 Participants
n=5 Participants
|
115 Participants
n=7 Participants
|
230 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Objective response was assessed by computed tomographic scan or other appropriate imaging at weeks 12 and 24 from randomization, and every 3 months thereafter, assessed up to 90 months.Objective response rate (ORR), according to Response Evaluation Criteria in Solid Tumors (RECIST),version 1.1, was the primary end point and was defined as the number of complete plus partial responses divided by the number of enrolled patients. Per RECIST v 1.1 for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Outcome measures
| Measure |
Bevacizumab Before Chemotherapy
n=115 Participants
Bevacizumab administered 4 days before each cycle of chemotherapy containing oxaliplatin (mFOLFOX-6 / mOXXEL)
Bevacizumab: 5 mg/kg every 2 weeks for up to 24 weeks. After 24 weeks, those patients without disease progression will receive bevacizumab 7.5 mg/kg every 3 weeks until progression of disease or unacceptable toxicity.
Oxaliplatin: 85mg/m2 IV every 2 weeks for up to 24 weeks
levo-folinic acid: 200 mg/m2 IV before 5-fluorouracil infusion, every 2 weeks up to 24 weeks
5-fluorouracil: 400 mg/m2 IV bolus followed by 2400 mg/m2 IV infusion over 46 hours, every 2 weeks for up to 24 weeks (given in mFOLFOX-6 schedule)
Capecitabine: 1000mg/m2 by mouth, twice a day for 10 days, every 2 weeks for up to 24 weeks(given in mOXXEL schedule)
|
Bevacizumab With Chemotherapy
n=115 Participants
Bevacizumab administered on the first day of each cycle of chemotherapy containing oxaliplatin (mFOLFOX-6 / mOXXEL)
Bevacizumab: 5 mg/kg every 2 weeks for up to 24 weeks. After 24 weeks, those patients without disease progression will receive bevacizumab 7.5 mg/kg every 3 weeks until progression of disease or unacceptable toxicity.
Oxaliplatin: 85mg/m2 IV every 2 weeks for up to 24 weeks
levo-folinic acid: 200 mg/m2 IV before 5-fluorouracil infusion, every 2 weeks up to 24 weeks
5-fluorouracil: 400 mg/m2 IV bolus followed by 2400 mg/m2 IV infusion over 46 hours, every 2 weeks for up to 24 weeks (given in mFOLFOX-6 schedule)
Capecitabine: 1000mg/m2 by mouth, twice a day for 10 days, every 2 weeks for up to 24 weeks(given in mOXXEL schedule)
|
|---|---|---|
|
Objective Response Rate
|
65 participants
Interval 47.0 to 65.7
|
66 participants
Interval 47.8 to 66.6
|
SECONDARY outcome
Timeframe: At weeks 12 and 24 from randomization and every 3 months thereafter, assessed up to 90 monthsDisease control rate was calculated by adding complete and partial responses and stable disease.
Outcome measures
| Measure |
Bevacizumab Before Chemotherapy
n=115 Participants
Bevacizumab administered 4 days before each cycle of chemotherapy containing oxaliplatin (mFOLFOX-6 / mOXXEL)
Bevacizumab: 5 mg/kg every 2 weeks for up to 24 weeks. After 24 weeks, those patients without disease progression will receive bevacizumab 7.5 mg/kg every 3 weeks until progression of disease or unacceptable toxicity.
Oxaliplatin: 85mg/m2 IV every 2 weeks for up to 24 weeks
levo-folinic acid: 200 mg/m2 IV before 5-fluorouracil infusion, every 2 weeks up to 24 weeks
5-fluorouracil: 400 mg/m2 IV bolus followed by 2400 mg/m2 IV infusion over 46 hours, every 2 weeks for up to 24 weeks (given in mFOLFOX-6 schedule)
Capecitabine: 1000mg/m2 by mouth, twice a day for 10 days, every 2 weeks for up to 24 weeks(given in mOXXEL schedule)
|
Bevacizumab With Chemotherapy
n=115 Participants
Bevacizumab administered on the first day of each cycle of chemotherapy containing oxaliplatin (mFOLFOX-6 / mOXXEL)
Bevacizumab: 5 mg/kg every 2 weeks for up to 24 weeks. After 24 weeks, those patients without disease progression will receive bevacizumab 7.5 mg/kg every 3 weeks until progression of disease or unacceptable toxicity.
Oxaliplatin: 85mg/m2 IV every 2 weeks for up to 24 weeks
levo-folinic acid: 200 mg/m2 IV before 5-fluorouracil infusion, every 2 weeks up to 24 weeks
5-fluorouracil: 400 mg/m2 IV bolus followed by 2400 mg/m2 IV infusion over 46 hours, every 2 weeks for up to 24 weeks (given in mFOLFOX-6 schedule)
Capecitabine: 1000mg/m2 by mouth, twice a day for 10 days, every 2 weeks for up to 24 weeks(given in mOXXEL schedule)
|
|---|---|---|
|
Disease Control Rate
|
107 Participants
|
103 Participants
|
SECONDARY outcome
Timeframe: assessed up to 90 monthsOverall survival was defined as the time from randomization to the date of death. Patients alive at the time of the final analysis were censored on the date of the last follow-up information available.
Outcome measures
| Measure |
Bevacizumab Before Chemotherapy
n=115 Participants
Bevacizumab administered 4 days before each cycle of chemotherapy containing oxaliplatin (mFOLFOX-6 / mOXXEL)
Bevacizumab: 5 mg/kg every 2 weeks for up to 24 weeks. After 24 weeks, those patients without disease progression will receive bevacizumab 7.5 mg/kg every 3 weeks until progression of disease or unacceptable toxicity.
Oxaliplatin: 85mg/m2 IV every 2 weeks for up to 24 weeks
levo-folinic acid: 200 mg/m2 IV before 5-fluorouracil infusion, every 2 weeks up to 24 weeks
5-fluorouracil: 400 mg/m2 IV bolus followed by 2400 mg/m2 IV infusion over 46 hours, every 2 weeks for up to 24 weeks (given in mFOLFOX-6 schedule)
Capecitabine: 1000mg/m2 by mouth, twice a day for 10 days, every 2 weeks for up to 24 weeks(given in mOXXEL schedule)
|
Bevacizumab With Chemotherapy
n=115 Participants
Bevacizumab administered on the first day of each cycle of chemotherapy containing oxaliplatin (mFOLFOX-6 / mOXXEL)
Bevacizumab: 5 mg/kg every 2 weeks for up to 24 weeks. After 24 weeks, those patients without disease progression will receive bevacizumab 7.5 mg/kg every 3 weeks until progression of disease or unacceptable toxicity.
Oxaliplatin: 85mg/m2 IV every 2 weeks for up to 24 weeks
levo-folinic acid: 200 mg/m2 IV before 5-fluorouracil infusion, every 2 weeks up to 24 weeks
5-fluorouracil: 400 mg/m2 IV bolus followed by 2400 mg/m2 IV infusion over 46 hours, every 2 weeks for up to 24 weeks (given in mFOLFOX-6 schedule)
Capecitabine: 1000mg/m2 by mouth, twice a day for 10 days, every 2 weeks for up to 24 weeks(given in mOXXEL schedule)
|
|---|---|---|
|
Overall Survival
|
29.8 months
Interval 22.5 to 41.1
|
24.1 months
Interval 18.6 to 29.8
|
SECONDARY outcome
Timeframe: assessed up to 90 monthsProgression-free survival was defined as the time from randomization to the date of progression or death, whichever occurred first. Patients without progression were censored on the date of the last follow-up visit. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Outcome measures
| Measure |
Bevacizumab Before Chemotherapy
n=115 Participants
Bevacizumab administered 4 days before each cycle of chemotherapy containing oxaliplatin (mFOLFOX-6 / mOXXEL)
Bevacizumab: 5 mg/kg every 2 weeks for up to 24 weeks. After 24 weeks, those patients without disease progression will receive bevacizumab 7.5 mg/kg every 3 weeks until progression of disease or unacceptable toxicity.
Oxaliplatin: 85mg/m2 IV every 2 weeks for up to 24 weeks
levo-folinic acid: 200 mg/m2 IV before 5-fluorouracil infusion, every 2 weeks up to 24 weeks
5-fluorouracil: 400 mg/m2 IV bolus followed by 2400 mg/m2 IV infusion over 46 hours, every 2 weeks for up to 24 weeks (given in mFOLFOX-6 schedule)
Capecitabine: 1000mg/m2 by mouth, twice a day for 10 days, every 2 weeks for up to 24 weeks(given in mOXXEL schedule)
|
Bevacizumab With Chemotherapy
n=115 Participants
Bevacizumab administered on the first day of each cycle of chemotherapy containing oxaliplatin (mFOLFOX-6 / mOXXEL)
Bevacizumab: 5 mg/kg every 2 weeks for up to 24 weeks. After 24 weeks, those patients without disease progression will receive bevacizumab 7.5 mg/kg every 3 weeks until progression of disease or unacceptable toxicity.
Oxaliplatin: 85mg/m2 IV every 2 weeks for up to 24 weeks
levo-folinic acid: 200 mg/m2 IV before 5-fluorouracil infusion, every 2 weeks up to 24 weeks
5-fluorouracil: 400 mg/m2 IV bolus followed by 2400 mg/m2 IV infusion over 46 hours, every 2 weeks for up to 24 weeks (given in mFOLFOX-6 schedule)
Capecitabine: 1000mg/m2 by mouth, twice a day for 10 days, every 2 weeks for up to 24 weeks(given in mOXXEL schedule)
|
|---|---|---|
|
Progression-free Survival (PFS)
|
11.7 months
Interval 9.9 to 12.9
|
10.5 months
Interval 9.1 to 12.3
|
SECONDARY outcome
Timeframe: up to 4 weeks after the end of the treatmentPopulation: any grade of toxic effects
Toxic effects were scored according to the National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE), version 4.0. For the National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE), version 4.0 scale score range from 1 to 4. A high score, that is 3 and 4, represents a high level of toxicity, whereas the minimum values, that is 1 and 2, represents a mild/modest level of toxicity.
Outcome measures
| Measure |
Bevacizumab Before Chemotherapy
n=114 Participants
Bevacizumab administered 4 days before each cycle of chemotherapy containing oxaliplatin (mFOLFOX-6 / mOXXEL)
Bevacizumab: 5 mg/kg every 2 weeks for up to 24 weeks. After 24 weeks, those patients without disease progression will receive bevacizumab 7.5 mg/kg every 3 weeks until progression of disease or unacceptable toxicity.
Oxaliplatin: 85mg/m2 IV every 2 weeks for up to 24 weeks
levo-folinic acid: 200 mg/m2 IV before 5-fluorouracil infusion, every 2 weeks up to 24 weeks
5-fluorouracil: 400 mg/m2 IV bolus followed by 2400 mg/m2 IV infusion over 46 hours, every 2 weeks for up to 24 weeks (given in mFOLFOX-6 schedule)
Capecitabine: 1000mg/m2 by mouth, twice a day for 10 days, every 2 weeks for up to 24 weeks(given in mOXXEL schedule)
|
Bevacizumab With Chemotherapy
n=115 Participants
Bevacizumab administered on the first day of each cycle of chemotherapy containing oxaliplatin (mFOLFOX-6 / mOXXEL)
Bevacizumab: 5 mg/kg every 2 weeks for up to 24 weeks. After 24 weeks, those patients without disease progression will receive bevacizumab 7.5 mg/kg every 3 weeks until progression of disease or unacceptable toxicity.
Oxaliplatin: 85mg/m2 IV every 2 weeks for up to 24 weeks
levo-folinic acid: 200 mg/m2 IV before 5-fluorouracil infusion, every 2 weeks up to 24 weeks
5-fluorouracil: 400 mg/m2 IV bolus followed by 2400 mg/m2 IV infusion over 46 hours, every 2 weeks for up to 24 weeks (given in mFOLFOX-6 schedule)
Capecitabine: 1000mg/m2 by mouth, twice a day for 10 days, every 2 weeks for up to 24 weeks(given in mOXXEL schedule)
|
|---|---|---|
|
Toxic Effects
|
108 Participants
|
113 Participants
|
Adverse Events
Bevacizumab Before Chemotherapy
Serious events: 65 serious events
Other events: 108 other events
Deaths: 2 deaths
Bevacizumab With Chemotherapy
Serious events: 75 serious events
Other events: 113 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Bevacizumab Before Chemotherapy
n=115 participants at risk
Bevacizumab administered 4 days before each cycle of chemotherapy containing oxaliplatin (mFOLFOX-6 / mOXXEL)
Bevacizumab: 5 mg/kg every 2 weeks for up to 24 weeks. After 24 weeks, those patients without disease progression will receive bevacizumab 7.5 mg/kg every 3 weeks until progression of disease or unacceptable toxicity.
Oxaliplatin: 85mg/m2 IV every 2 weeks for up to 24 weeks
levo-folinic acid: 200 mg/m2 IV before 5-fluorouracil infusion, every 2 weeks up to 24 weeks
5-fluorouracil: 400 mg/m2 IV bolus followed by 2400 mg/m2 IV infusion over 46 hours, every 2 weeks for up to 24 weeks (given in mFOLFOX-6 schedule)
Capecitabine: 1000mg/m2 by mouth, twice a day for 10 days, every 2 weeks for up to 24 weeks(given in mOXXEL schedule)
|
Bevacizumab With Chemotherapy
n=115 participants at risk
Bevacizumab administered on the first day of each cycle of chemotherapy containing oxaliplatin (mFOLFOX-6 / mOXXEL)
Bevacizumab: 5 mg/kg every 2 weeks for up to 24 weeks. After 24 weeks, those patients without disease progression will receive bevacizumab 7.5 mg/kg every 3 weeks until progression of disease or unacceptable toxicity.
Oxaliplatin: 85mg/m2 IV every 2 weeks for up to 24 weeks
levo-folinic acid: 200 mg/m2 IV before 5-fluorouracil infusion, every 2 weeks up to 24 weeks
5-fluorouracil: 400 mg/m2 IV bolus followed by 2400 mg/m2 IV infusion over 46 hours, every 2 weeks for up to 24 weeks (given in mFOLFOX-6 schedule)
Capecitabine: 1000mg/m2 by mouth, twice a day for 10 days, every 2 weeks for up to 24 weeks(given in mOXXEL schedule)
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
5.2%
6/115 • Number of events 6 • Evaluated every 2 weeks up to 6 months
|
16.5%
19/115 • Number of events 19 • Evaluated every 2 weeks up to 6 months
|
|
Blood and lymphatic system disorders
Anemia
|
2.6%
3/115 • Number of events 3 • Evaluated every 2 weeks up to 6 months
|
1.7%
2/115 • Number of events 2 • Evaluated every 2 weeks up to 6 months
|
|
Gastrointestinal disorders
Abdominal pain
|
1.7%
2/115 • Number of events 2 • Evaluated every 2 weeks up to 6 months
|
4.3%
5/115 • Number of events 5 • Evaluated every 2 weeks up to 6 months
|
|
Infections and infestations
Mucositis oral
|
3.5%
4/115 • Number of events 4 • Evaluated every 2 weeks up to 6 months
|
5.2%
6/115 • Number of events 6 • Evaluated every 2 weeks up to 6 months
|
|
Gastrointestinal disorders
Nausea
|
1.7%
2/115 • Number of events 2 • Evaluated every 2 weeks up to 6 months
|
7.0%
8/115 • Number of events 8 • Evaluated every 2 weeks up to 6 months
|
|
Gastrointestinal disorders
Vomiting
|
0.87%
1/115 • Number of events 1 • Evaluated every 2 weeks up to 6 months
|
0.87%
1/115 • Number of events 1 • Evaluated every 2 weeks up to 6 months
|
|
General disorders
Fatigue
|
3.5%
4/115 • Number of events 4 • Evaluated every 2 weeks up to 6 months
|
4.3%
5/115 • Number of events 5 • Evaluated every 2 weeks up to 6 months
|
|
General disorders
Fever
|
0.87%
1/115 • Number of events 1 • Evaluated every 2 weeks up to 6 months
|
0.87%
1/115 • Number of events 1 • Evaluated every 2 weeks up to 6 months
|
|
General disorders
Pain
|
0.87%
1/115 • Number of events 1 • Evaluated every 2 weeks up to 6 months
|
0.87%
1/115 • Number of events 1 • Evaluated every 2 weeks up to 6 months
|
|
Immune system disorders
Allergic reaction
|
1.7%
2/115 • Number of events 2 • Evaluated every 2 weeks up to 6 months
|
3.5%
4/115 • Number of events 4 • Evaluated every 2 weeks up to 6 months
|
|
Hepatobiliary disorders
Alanine aminotransferase level increased
|
0.87%
1/115 • Number of events 1 • Evaluated every 2 weeks up to 6 months
|
0.87%
1/115 • Number of events 1 • Evaluated every 2 weeks up to 6 months
|
|
Hepatobiliary disorders
Alkaline phosphatase level increased
|
0.87%
1/115 • Number of events 1 • Evaluated every 2 weeks up to 6 months
|
0.87%
1/115 • Number of events 1 • Evaluated every 2 weeks up to 6 months
|
|
Blood and lymphatic system disorders
Neutrophil count decreased
|
20.0%
23/115 • Number of events 23 • Evaluated every 2 weeks up to 6 months
|
24.3%
28/115 • Number of events 28 • Evaluated every 2 weeks up to 6 months
|
|
Blood and lymphatic system disorders
Platelet count decreased
|
1.7%
2/115 • Number of events 2 • Evaluated every 2 weeks up to 6 months
|
0.87%
1/115 • Number of events 1 • Evaluated every 2 weeks up to 6 months
|
|
Blood and lymphatic system disorders
White blood cell count decreased
|
4.3%
5/115 • Number of events 5 • Evaluated every 2 weeks up to 6 months
|
7.0%
8/115 • Number of events 8 • Evaluated every 2 weeks up to 6 months
|
|
Nervous system disorders
Peripheral neuropathy
|
13.0%
15/115 • Number of events 15 • Evaluated every 2 weeks up to 6 months
|
13.0%
15/115 • Number of events 15 • Evaluated every 2 weeks up to 6 months
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
4.3%
5/115 • Number of events 5 • Evaluated every 2 weeks up to 6 months
|
3.5%
4/115 • Number of events 4 • Evaluated every 2 weeks up to 6 months
|
|
Cardiac disorders
Hypertension
|
2.6%
3/115 • Number of events 3 • Evaluated every 2 weeks up to 6 months
|
6.1%
7/115 • Number of events 7 • Evaluated every 2 weeks up to 6 months
|
|
Vascular disorders
Thromboembolic event
|
1.7%
2/115 • Number of events 2 • Evaluated every 2 weeks up to 6 months
|
2.6%
3/115 • Number of events 3 • Evaluated every 2 weeks up to 6 months
|
Other adverse events
| Measure |
Bevacizumab Before Chemotherapy
n=115 participants at risk
Bevacizumab administered 4 days before each cycle of chemotherapy containing oxaliplatin (mFOLFOX-6 / mOXXEL)
Bevacizumab: 5 mg/kg every 2 weeks for up to 24 weeks. After 24 weeks, those patients without disease progression will receive bevacizumab 7.5 mg/kg every 3 weeks until progression of disease or unacceptable toxicity.
Oxaliplatin: 85mg/m2 IV every 2 weeks for up to 24 weeks
levo-folinic acid: 200 mg/m2 IV before 5-fluorouracil infusion, every 2 weeks up to 24 weeks
5-fluorouracil: 400 mg/m2 IV bolus followed by 2400 mg/m2 IV infusion over 46 hours, every 2 weeks for up to 24 weeks (given in mFOLFOX-6 schedule)
Capecitabine: 1000mg/m2 by mouth, twice a day for 10 days, every 2 weeks for up to 24 weeks(given in mOXXEL schedule)
|
Bevacizumab With Chemotherapy
n=115 participants at risk
Bevacizumab administered on the first day of each cycle of chemotherapy containing oxaliplatin (mFOLFOX-6 / mOXXEL)
Bevacizumab: 5 mg/kg every 2 weeks for up to 24 weeks. After 24 weeks, those patients without disease progression will receive bevacizumab 7.5 mg/kg every 3 weeks until progression of disease or unacceptable toxicity.
Oxaliplatin: 85mg/m2 IV every 2 weeks for up to 24 weeks
levo-folinic acid: 200 mg/m2 IV before 5-fluorouracil infusion, every 2 weeks up to 24 weeks
5-fluorouracil: 400 mg/m2 IV bolus followed by 2400 mg/m2 IV infusion over 46 hours, every 2 weeks for up to 24 weeks (given in mFOLFOX-6 schedule)
Capecitabine: 1000mg/m2 by mouth, twice a day for 10 days, every 2 weeks for up to 24 weeks(given in mOXXEL schedule)
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
24.3%
28/115 • Number of events 28 • Evaluated every 2 weeks up to 6 months
|
23.5%
27/115 • Number of events 27 • Evaluated every 2 weeks up to 6 months
|
|
Gastrointestinal disorders
Abdominal pain
|
2.6%
3/115 • Number of events 3 • Evaluated every 2 weeks up to 6 months
|
8.7%
10/115 • Number of events 10 • Evaluated every 2 weeks up to 6 months
|
|
Gastrointestinal disorders
Diarrhea
|
23.5%
27/115 • Number of events 27 • Evaluated every 2 weeks up to 6 months
|
38.3%
44/115 • Number of events 44 • Evaluated every 2 weeks up to 6 months
|
|
Infections and infestations
Mucositis oral
|
22.6%
26/115 • Number of events 26 • Evaluated every 2 weeks up to 6 months
|
29.6%
34/115 • Number of events 34 • Evaluated every 2 weeks up to 6 months
|
|
Gastrointestinal disorders
Nausea
|
38.3%
44/115 • Number of events 44 • Evaluated every 2 weeks up to 6 months
|
38.3%
44/115 • Number of events 44 • Evaluated every 2 weeks up to 6 months
|
|
Gastrointestinal disorders
Vomiting
|
5.2%
6/115 • Number of events 6 • Evaluated every 2 weeks up to 6 months
|
8.7%
10/115 • Number of events 10 • Evaluated every 2 weeks up to 6 months
|
|
General disorders
Fatigue
|
13.9%
16/115 • Number of events 16 • Evaluated every 2 weeks up to 6 months
|
26.1%
30/115 • Number of events 30 • Evaluated every 2 weeks up to 6 months
|
|
General disorders
Fever
|
7.0%
8/115 • Number of events 8 • Evaluated every 2 weeks up to 6 months
|
6.1%
7/115 • Number of events 7 • Evaluated every 2 weeks up to 6 months
|
|
General disorders
Pain
|
4.3%
5/115 • Number of events 5 • Evaluated every 2 weeks up to 6 months
|
2.6%
3/115 • Number of events 3 • Evaluated every 2 weeks up to 6 months
|
|
Immune system disorders
Allergic reaction
|
2.6%
3/115 • Number of events 3 • Evaluated every 2 weeks up to 6 months
|
3.5%
4/115 • Number of events 4 • Evaluated every 2 weeks up to 6 months
|
|
Hepatobiliary disorders
Alanine aminotransferase level increased
|
20.0%
23/115 • Number of events 23 • Evaluated every 2 weeks up to 6 months
|
20.0%
23/115 • Number of events 23 • Evaluated every 2 weeks up to 6 months
|
|
Hepatobiliary disorders
Alkaline phosphatase level increased
|
19.1%
22/115 • Number of events 22 • Evaluated every 2 weeks up to 6 months
|
20.0%
23/115 • Number of events 23 • Evaluated every 2 weeks up to 6 months
|
|
Blood and lymphatic system disorders
Neutrophil count decreased
|
36.5%
42/115 • Number of events 42 • Evaluated every 2 weeks up to 6 months
|
38.3%
44/115 • Number of events 44 • Evaluated every 2 weeks up to 6 months
|
|
Blood and lymphatic system disorders
Platelet count decreased
|
17.4%
20/115 • Number of events 20 • Evaluated every 2 weeks up to 6 months
|
27.8%
32/115 • Number of events 32 • Evaluated every 2 weeks up to 6 months
|
|
Blood and lymphatic system disorders
White blood cell count decreased
|
24.3%
28/115 • Number of events 28 • Evaluated every 2 weeks up to 6 months
|
30.4%
35/115 • Number of events 35 • Evaluated every 2 weeks up to 6 months
|
|
Nervous system disorders
Peripheral neuropathy
|
55.7%
64/115 • Number of events 64 • Evaluated every 2 weeks up to 6 months
|
60.9%
70/115 • Number of events 70 • Evaluated every 2 weeks up to 6 months
|
|
Renal and urinary disorders
Proteinuria
|
8.7%
10/115 • Number of events 10 • Evaluated every 2 weeks up to 6 months
|
2.6%
3/115 • Number of events 3 • Evaluated every 2 weeks up to 6 months
|
|
Vascular disorders
Epistaxis
|
13.0%
15/115 • Number of events 157 • Evaluated every 2 weeks up to 6 months
|
6.1%
7/115 • Number of events 7 • Evaluated every 2 weeks up to 6 months
|
|
General disorders
Voice alteration
|
6.1%
7/115 • Number of events 7 • Evaluated every 2 weeks up to 6 months
|
5.2%
6/115 • Number of events 6 • Evaluated every 2 weeks up to 6 months
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
16.5%
19/115 • Number of events 19 • Evaluated every 2 weeks up to 6 months
|
20.0%
23/115 • Number of events 23 • Evaluated every 2 weeks up to 6 months
|
|
Cardiac disorders
Hypertension
|
27.8%
32/115 • Number of events 32 • Evaluated every 2 weeks up to 6 months
|
21.7%
25/115 • Number of events 25 • Evaluated every 2 weeks up to 6 months
|
|
Vascular disorders
Thromboembolic event
|
1.7%
2/115 • Number of events 2 • Evaluated every 2 weeks up to 6 months
|
5.2%
6/115 • Number of events 6 • Evaluated every 2 weeks up to 6 months
|
Additional Information
Antonio Avallone, Dierctor of Experimental Abdominal Medcial Oncology
National Cancer Institute, IRCCS, G. Pascale Foundation
Phone: +390815903629
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place