Trial Outcomes & Findings for Phase II Trial of FOLFOX6, Bevacizumab and Cetuximab in Patients With Colorectal Cancer (NCT NCT00100841)
NCT ID: NCT00100841
Last Updated: 2015-07-27
Results Overview
The primary objective is to evaluate safety in all treated patients specifically the rate of serious adverse events which were defined as grade 5 events, grade 4 hemorrhage or thrombosis or bowel perforation
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
66 participants
Primary outcome timeframe
The duration of the study
Results posted on
2015-07-27
Participant Flow
A total of 67 patients were enrolled from between December 2004 and November 2006
One patient was enrolled but never started treatment
Participant milestones
| Measure |
Treatment (Combination Chemotherapy)
Patients receive cetuximab IV over 60-120 minutes on day 1 in weeks 1-8. Patients also receive bevacizumab IV over 30-90 minutes, oxaliplatin IV over 2 hours, and leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV continuously over 48 hours on days 1 and 2 of weeks 1, 3, 5, and 7. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.
cetuximab: Given IV
bevacizumab: Given IV
oxaliplatin: Given IV
leucovorin calcium: Given IV
fluorouracil: Given IV
|
|---|---|
|
Overall Study
STARTED
|
66
|
|
Overall Study
COMPLETED
|
66
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase II Trial of FOLFOX6, Bevacizumab and Cetuximab in Patients With Colorectal Cancer
Baseline characteristics by cohort
| Measure |
Treatment (Combination Chemotherapy)
n=66 Participants
Patients receive cetuximab IV over 60-120 minutes on day 1 in weeks 1-8. Patients also receive bevacizumab IV over 30-90 minutes, oxaliplatin IV over 2 hours, and leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV continuously over 48 hours on days 1 and 2 of weeks 1, 3, 5, and 7. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.
cetuximab: Given IV
bevacizumab: Given IV
oxaliplatin: Given IV
leucovorin calcium: Given IV
fluorouracil: Given IV
|
|---|---|
|
Age, Continuous
|
57 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
35 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
51 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
10 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
3 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: The duration of the studyPopulation: 66 patients treated with cetuximab
The primary objective is to evaluate safety in all treated patients specifically the rate of serious adverse events which were defined as grade 5 events, grade 4 hemorrhage or thrombosis or bowel perforation
Outcome measures
| Measure |
Treatment (Combination Chemotherapy)
n=66 Participants
Patients receive cetuximab IV over 60-120 minutes on day 1 in weeks 1-8. Patients also receive bevacizumab IV over 30-90 minutes, oxaliplatin IV over 2 hours, and leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV continuously over 48 hours on days 1 and 2 of weeks 1, 3, 5, and 7. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.
cetuximab: Given IV
bevacizumab: Given IV
oxaliplatin: Given IV
leucovorin calcium: Given IV
fluorouracil: Given IV
|
|---|---|
|
Severe Adverse Event (SAE) Rate
Grade 5 Death
|
2 participants
|
|
Severe Adverse Event (SAE) Rate
Grade 4 venous thrombosis
|
2 participants
|
PRIMARY outcome
Timeframe: From randomization to the first documented disease progressionOutcome measures
| Measure |
Treatment (Combination Chemotherapy)
n=38 Participants
Patients receive cetuximab IV over 60-120 minutes on day 1 in weeks 1-8. Patients also receive bevacizumab IV over 30-90 minutes, oxaliplatin IV over 2 hours, and leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV continuously over 48 hours on days 1 and 2 of weeks 1, 3, 5, and 7. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.
cetuximab: Given IV
bevacizumab: Given IV
oxaliplatin: Given IV
leucovorin calcium: Given IV
fluorouracil: Given IV
|
|---|---|
|
Progression Free Survival Rate
|
9.6 months
Interval 9.5 to 12.2
|
Adverse Events
Treatment (Combination Chemotherapy)
Serious events: 54 serious events
Other events: 63 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment (Combination Chemotherapy)
n=66 participants at risk
Patients receive cetuximab IV over 60-120 minutes on day 1 in weeks 1-8. Patients also receive bevacizumab IV over 30-90 minutes, oxaliplatin IV over 2 hours, and leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV continuously over 48 hours on days 1 and 2 of weeks 1, 3, 5, and 7. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.
cetuximab: Given IV
bevacizumab: Given IV
oxaliplatin: Given IV
leucovorin calcium: Given IV
fluorouracil: Given IV
|
|---|---|
|
Blood and lymphatic system disorders
Hemoglobin (anemia)
|
3.0%
2/66 • Number of events 2
|
|
Blood and lymphatic system disorders
Neutropenia
|
22.7%
15/66 • Number of events 15
|
|
Infections and infestations
Catheter-related infection
|
3.0%
2/66 • Number of events 2
|
|
Investigations
Platelet count decreased
|
3.0%
2/66 • Number of events 2
|
|
Infections and infestations
Ungual (nails) infection
|
1.5%
1/66 • Number of events 1
|
|
Cardiac disorders
Cardiopulmonary-restrictive
|
1.5%
1/66 • Number of events 1
|
|
Cardiac disorders
Hypotension
|
3.0%
2/66 • Number of events 2
|
|
Metabolism and nutrition disorders
Anorexia
|
3.0%
2/66 • Number of events 2
|
|
General disorders
Fatigue
|
13.6%
9/66 • Number of events 9
|
|
Nervous system disorders
Cerebrovascular ischemia
|
1.5%
1/66 • Number of events 1
|
|
Vascular disorders
Thromboembolic event
|
1.5%
1/66 • Number of events 1
|
|
Investigations
Alkaline phosphatase
|
3.0%
2/66 • Number of events 2
|
|
Investigations
Alanine transaminase
|
3.0%
2/66 • Number of events 2
|
|
Investigations
Aspartate transaminase
|
1.5%
1/66 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
1.5%
1/66 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
1.5%
1/66 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhea
|
13.6%
9/66 • Number of events 9
|
|
Gastrointestinal disorders
Oral mucositis
|
3.0%
2/66 • Number of events 2
|
|
Gastrointestinal disorders
Nausea
|
1.5%
1/66 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
3.0%
2/66 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Rash: acne/acneiform
|
7.6%
5/66 • Number of events 5
|
|
Gastrointestinal disorders
Vomiting
|
4.5%
3/66 • Number of events 3
|
|
Nervous system disorders
Neuropathy: Sensory
|
12.1%
8/66 • Number of events 8
|
|
Gastrointestinal disorders
Abdominal pain
|
9.1%
6/66 • Number of events 6
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
1.5%
1/66 • Number of events 1
|
|
Renal and urinary disorders
Proteinuria
|
1.5%
1/66 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
4.5%
3/66 • Number of events 3
|
|
Metabolism and nutrition disorders
Hypokalemia
|
1.5%
1/66 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
3.0%
2/66 • Number of events 2
|
Other adverse events
| Measure |
Treatment (Combination Chemotherapy)
n=66 participants at risk
Patients receive cetuximab IV over 60-120 minutes on day 1 in weeks 1-8. Patients also receive bevacizumab IV over 30-90 minutes, oxaliplatin IV over 2 hours, and leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV continuously over 48 hours on days 1 and 2 of weeks 1, 3, 5, and 7. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.
cetuximab: Given IV
bevacizumab: Given IV
oxaliplatin: Given IV
leucovorin calcium: Given IV
fluorouracil: Given IV
|
|---|---|
|
Infections and infestations
Eye infection
|
9.1%
6/66 • Number of events 6
|
|
Infections and infestations
Upper airway infection
|
7.6%
5/66 • Number of events 5
|
|
Infections and infestations
Upper tract infection
|
4.5%
3/66 • Number of events 3
|
|
Vascular disorders
Hypertension
|
15.2%
10/66 • Number of events 10
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage: nose
|
18.2%
12/66 • Number of events 12
|
|
Gastrointestinal disorders
Hemorrhage: lower gastrointestinal
|
10.6%
7/66 • Number of events 7
|
|
Renal and urinary disorders
Hemorrhage: urine
|
7.6%
5/66 • Number of events 5
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
16.7%
11/66 • Number of events 11
|
|
Skin and subcutaneous tissue disorders
Hand-foot reaction
|
24.2%
16/66 • Number of events 16
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
15.2%
10/66 • Number of events 10
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
15.2%
10/66 • Number of events 10
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60