Trial Outcomes & Findings for Combination of Cetuximab, Capecitabine, and Oxaliplatin With or Without Bevacizumab (NCT NCT00321100)
NCT ID: NCT00321100
Last Updated: 2022-01-12
Results Overview
Objective response rate calculated by the proportion of overall response: CR+PR. Patients were categorized by one of the following (1-4 per RECISTv1.0 criteria on CT, MRI, x-ray; 4-9 considered failure to respond/disease progression): 1. complete response (CR): Disappearance of all lesions 2. partial response (PR): \>=30% decrease in the sum of the longest diameter of target lesions (SoL); from baseline SoL 3. stable disease (SD): Neither PR, PD, or CR 4. progressive disease (PD): \>=20% increase in the SoL; from smallest SoL. Or appearance of new lesion 5. early death from malignant disease 6. early death from toxicity 7. early death from other cause 9\) unknown (not assessable, insufficient data)
TERMINATED
PHASE2
23 participants
every 6-9 weeks; from date of first study drug dose until off treatment date (median of 8 cycles; range <1-19)
2022-01-12
Participant Flow
Participant milestones
| Measure |
Cetuximab, Oxaliplatin, Capecitabine, Bevacizumab
Cetuximab: 400 mg/m2 initial dose (cycle 1 day 1 only), then 250mg/m2 IV weekly of each 21 day cycle
Oxaliplatin: 130mg/m2 IV day 1 of each 21 day cycle
Capecitabine: 850mg/m2 PO every 12 hours days 1-14 of each 21 day cycle
Bevacizumab: 7.5mg/kg IV day 1 of each 21 day cycle
|
Cetuximab, Oxaliplatin, Capecitabine
Cetuximab: 400 mg/m2 initial dose (cycle 1 day 1 only), then 250mg/m2 IV weekly of each 21 day cycle
Oxaliplatin: 130mg/m2 IV day 1 of each 21 day cycle
Capecitabine: 850mg/m2 PO every 12 hours days 1-14 of each 21 day cycle
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
11
|
|
Overall Study
COMPLETED
|
12
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Combination of Cetuximab, Capecitabine, and Oxaliplatin With or Without Bevacizumab
Baseline characteristics by cohort
| Measure |
Cetuximab, Oxaliplatin, Capecitabine, Bevacizumab
n=12 Participants
Cetuximab: 400 mg/m2 initial dose (cycle 1 day 1 only), then 250mg/m2 IV weekly of each 21 day cycle
Oxaliplatin: 130mg/m2 IV day 1 of each 21 day cycle
Capecitabine: 850mg/m2 PO every 12 hours days 1-14 of each 21 day cycle
Bevacizumab: 7.5mg/kg IV day 1 of each 21 day cycle
|
Cetuximab, Oxaliplatin, Capecitabine
n=11 Participants
Cetuximab: 400 mg/m2 initial dose (cycle 1 day 1 only), then 250mg/m2 IV weekly of each 21 day cycle
Oxaliplatin: 130mg/m2 IV day 1 of each 21 day cycle
Capecitabine: 850mg/m2 PO every 12 hours days 1-14 of each 21 day cycle
|
Total
n=23 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59 years
n=5 Participants
|
58 years
n=7 Participants
|
59 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
18 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
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
19 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
|
|
Region of Enrollment
United States
|
12 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: every 6-9 weeks; from date of first study drug dose until off treatment date (median of 8 cycles; range <1-19)Population: One patient in Cetuximab, Oxaliplatin, Capecitabine, Bevacizumab Arm was not evaluable for response due to patient discontinuing after experiencing a hypersensitivity reaction to cetuximab during the first treatment.
Objective response rate calculated by the proportion of overall response: CR+PR. Patients were categorized by one of the following (1-4 per RECISTv1.0 criteria on CT, MRI, x-ray; 4-9 considered failure to respond/disease progression): 1. complete response (CR): Disappearance of all lesions 2. partial response (PR): \>=30% decrease in the sum of the longest diameter of target lesions (SoL); from baseline SoL 3. stable disease (SD): Neither PR, PD, or CR 4. progressive disease (PD): \>=20% increase in the SoL; from smallest SoL. Or appearance of new lesion 5. early death from malignant disease 6. early death from toxicity 7. early death from other cause 9\) unknown (not assessable, insufficient data)
Outcome measures
| Measure |
Cetuximab, Oxaliplatin, Capecitabine, Bevacizumab
n=11 Participants
Cetuximab: 400 mg/m2 initial dose (cycle 1 day 1 only), then 250mg/m2 IV weekly of each 21 day cycle
Oxaliplatin: 130mg/m2 IV day 1 of each 21 day cycle
Capecitabine: 850mg/m2 PO every 12 hours days 1-14 of each 21 day cycle
Bevacizumab: 7.5mg/kg IV day 1 of each 21 day cycle
|
Cetuximab, Oxaliplatin, Capecitabine
n=11 Participants
Cetuximab: 400 mg/m2 initial dose (cycle 1 day 1 only), then 250mg/m2 IV weekly of each 21 day cycle
Oxaliplatin: 130mg/m2 IV day 1 of each 21 day cycle
Capecitabine: 850mg/m2 PO every 12 hours days 1-14 of each 21 day cycle
|
|---|---|---|
|
Objective Response Rate (ORR)
Overall response
|
4 Participants
|
8 Participants
|
|
Objective Response Rate (ORR)
Complete response
|
1 Participants
|
1 Participants
|
|
Objective Response Rate (ORR)
Partial response
|
3 Participants
|
7 Participants
|
|
Objective Response Rate (ORR)
Stable disease
|
7 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: every 6-9 weeks; from dose of first study drug to eventPopulation: One patient in Cetuximab, Oxaliplatin, Capecitabine, Bevacizumab Arm was not evaluable for response due to patient discontinuing after experiencing a hypersensitivity reaction to cetuximab during the first treatment.
Per Response Evaluation Criteria In Solid Tumors (RECISTv1.0) assessed by CT, MRI, x-ray scan: Complete response (CR): Disappearance of all lesions Partial response (PR): \>=30% decrease in the sum of the longest diameter of target lesions (SoL); from baseline SoL Stable disease (SD): Neither PR, PD, or CR Progressive disease (PD): \>=20% increase in the SoL; from smallest SoL. Or appearance of new lesion
Outcome measures
| Measure |
Cetuximab, Oxaliplatin, Capecitabine, Bevacizumab
n=11 Participants
Cetuximab: 400 mg/m2 initial dose (cycle 1 day 1 only), then 250mg/m2 IV weekly of each 21 day cycle
Oxaliplatin: 130mg/m2 IV day 1 of each 21 day cycle
Capecitabine: 850mg/m2 PO every 12 hours days 1-14 of each 21 day cycle
Bevacizumab: 7.5mg/kg IV day 1 of each 21 day cycle
|
Cetuximab, Oxaliplatin, Capecitabine
n=11 Participants
Cetuximab: 400 mg/m2 initial dose (cycle 1 day 1 only), then 250mg/m2 IV weekly of each 21 day cycle
Oxaliplatin: 130mg/m2 IV day 1 of each 21 day cycle
Capecitabine: 850mg/m2 PO every 12 hours days 1-14 of each 21 day cycle
|
|---|---|---|
|
Time to Progression (TTP)
|
8.7 months
The PI has left the institution and the only access to the data is from publications. The access to this specific information/data cannot be confirmed and/or is not available to be reported.
|
14.4 months
The PI has left the institution and the only access to the data is from publications. The access to this specific information/data cannot be confirmed and/or is not available to be reported.
|
SECONDARY outcome
Timeframe: From dose of first study drug to last timepoint known to be alive (median follow-up for all patients was 25.9 months)Population: One patient in Cetuximab, Oxaliplatin, Capecitabine, Bevacizumab Arm was not evaluable for response due to patient discontinuing after experiencing a hypersensitivity reaction to cetuximab during the first treatment.
Follow-up for survival to be done at 3 month intervals for 2 years, then 6 month intervals for up to 5 years from study registration
Outcome measures
| Measure |
Cetuximab, Oxaliplatin, Capecitabine, Bevacizumab
n=11 Participants
Cetuximab: 400 mg/m2 initial dose (cycle 1 day 1 only), then 250mg/m2 IV weekly of each 21 day cycle
Oxaliplatin: 130mg/m2 IV day 1 of each 21 day cycle
Capecitabine: 850mg/m2 PO every 12 hours days 1-14 of each 21 day cycle
Bevacizumab: 7.5mg/kg IV day 1 of each 21 day cycle
|
Cetuximab, Oxaliplatin, Capecitabine
n=11 Participants
Cetuximab: 400 mg/m2 initial dose (cycle 1 day 1 only), then 250mg/m2 IV weekly of each 21 day cycle
Oxaliplatin: 130mg/m2 IV day 1 of each 21 day cycle
Capecitabine: 850mg/m2 PO every 12 hours days 1-14 of each 21 day cycle
|
|---|---|---|
|
Overall Survival
|
18 months
The PI has left the institution and the only access to the data is from publications. The access to this specific information/data cannot be confirmed and/or is not available to be reported.
|
42.5 months
The PI has left the institution and the only access to the data is from publications. The access to this specific information/data cannot be confirmed and/or is not available to be reported.
|
Adverse Events
Cetuximab, Oxaliplatin, Capecitabine, Bevacizumab
Cetuximab, Oxaliplatin, Capecitabine
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cetuximab, Oxaliplatin, Capecitabine, Bevacizumab
n=12 participants at risk
Cetuximab: 400 mg/m2 initial dose (cycle 1 day 1 only), then 250mg/m2 IV weekly of each 21 day cycle
Oxaliplatin: 130mg/m2 IV day 1 of each 21 day cycle
Capecitabine: 850mg/m2 PO every 12 hours days 1-14 of each 21 day cycle
Bevacizumab: 7.5mg/kg IV day 1 of each 21 day cycle
|
Cetuximab, Oxaliplatin, Capecitabine
n=11 participants at risk
Cetuximab: 400 mg/m2 initial dose (cycle 1 day 1 only), then 250mg/m2 IV weekly of each 21 day cycle
Oxaliplatin: 130mg/m2 IV day 1 of each 21 day cycle
Capecitabine: 850mg/m2 PO every 12 hours days 1-14 of each 21 day cycle
|
|---|---|---|
|
Immune system disorders
Hypersensitivity reaction
|
33.3%
4/12
|
9.1%
1/11
|
|
Blood and lymphatic system disorders
Neutropenia
|
25.0%
3/12
|
54.5%
6/11
|
|
Blood and lymphatic system disorders
Infection with neutropenia
|
0.00%
0/12
|
9.1%
1/11
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
16.7%
2/12
|
63.6%
7/11
|
|
Vascular disorders
Hemmorhage
|
50.0%
6/12
|
36.4%
4/11
|
|
Vascular disorders
DVT
|
0.00%
0/12
|
27.3%
3/11
|
|
Vascular disorders
Hypertension
|
50.0%
6/12
|
18.2%
2/11
|
|
General disorders
Edema
|
16.7%
2/12
|
9.1%
1/11
|
|
General disorders
Fatigue
|
91.7%
11/12
|
100.0%
11/11
|
|
General disorders
Pain
|
75.0%
9/12
|
81.8%
9/11
|
|
General disorders
Fever
|
16.7%
2/12
|
36.4%
4/11
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/12
|
9.1%
1/11
|
|
Skin and subcutaneous tissue disorders
Dry/cracked skin
|
25.0%
3/12
|
36.4%
4/11
|
|
Skin and subcutaneous tissue disorders
Fissures
|
58.3%
7/12
|
27.3%
3/11
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
16.7%
2/12
|
27.3%
3/11
|
|
Skin and subcutaneous tissue disorders
Paronychia
|
41.7%
5/12
|
63.6%
7/11
|
|
Skin and subcutaneous tissue disorders
Rash
|
91.7%
11/12
|
100.0%
11/11
|
|
Skin and subcutaneous tissue disorders
Hand-foot syndrome
|
8.3%
1/12
|
36.4%
4/11
|
|
Gastrointestinal disorders
Constipation
|
58.3%
7/12
|
54.5%
6/11
|
|
Gastrointestinal disorders
Diarrhea
|
75.0%
9/12
|
100.0%
11/11
|
|
Gastrointestinal disorders
Nausea
|
75.0%
9/12
|
63.6%
7/11
|
|
Gastrointestinal disorders
Vomiting
|
41.7%
5/12
|
18.2%
2/11
|
|
Metabolism and nutrition disorders
Weight loss
|
25.0%
3/12
|
27.3%
3/11
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
50.0%
6/12
|
54.5%
6/11
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
50.0%
6/12
|
72.7%
8/11
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
16.7%
2/12
|
45.5%
5/11
|
|
Metabolism and nutrition disorders
Hypokalemia
|
8.3%
1/12
|
27.3%
3/11
|
|
Nervous system disorders
Parasthesias
|
66.7%
8/12
|
72.7%
8/11
|
|
Nervous system disorders
Parasthesias/pain
|
8.3%
1/12
|
9.1%
1/11
|
|
Nervous system disorders
Sensory neuropathy
|
41.7%
5/12
|
54.5%
6/11
|
|
Nervous system disorders
Insomnia
|
25.0%
3/12
|
27.3%
3/11
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place