Trial Outcomes & Findings for Study of Biweekly Capecitabine Dosing With Bevacizumab for the Treatment of Metastatic Breast Cancer Based Upon the Norton-Simon Mathematical Model (NCT NCT00468585)
NCT ID: NCT00468585
Last Updated: 2016-01-22
Results Overview
This is defined as the percentage of patients who achieve either an objective complete or partial target lesion response that is confirmed based on the RECIST criteria.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
62 participants
Primary outcome timeframe
2 years
Results posted on
2016-01-22
Participant Flow
Participant milestones
| Measure |
Group 0
Capecitabine - AM 1500mg; PM 1500 mg; total daily 3000 mg
|
Group 1
Capecitabine - AM 1500 mg; PM 2000 mg; total daily 3500 mg
|
Group 2
Capecitabine - AM 2000 mg; PM 2000 mg; total daily 4000 mg
|
Group 3
Capecitabine - AM 2000 mg; PM 2500mg; total daily 4500 mg
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
3
|
50
|
6
|
|
Overall Study
COMPLETED
|
3
|
3
|
45
|
5
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
5
|
1
|
Reasons for withdrawal
| Measure |
Group 0
Capecitabine - AM 1500mg; PM 1500 mg; total daily 3000 mg
|
Group 1
Capecitabine - AM 1500 mg; PM 2000 mg; total daily 3500 mg
|
Group 2
Capecitabine - AM 2000 mg; PM 2000 mg; total daily 4000 mg
|
Group 3
Capecitabine - AM 2000 mg; PM 2500mg; total daily 4500 mg
|
|---|---|---|---|---|
|
Overall Study
Patient not treated
|
1
|
0
|
1
|
0
|
|
Overall Study
Patient found to be ineligible
|
0
|
0
|
1
|
0
|
|
Overall Study
Adverse Event
|
0
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
2
|
1
|
Baseline Characteristics
Study of Biweekly Capecitabine Dosing With Bevacizumab for the Treatment of Metastatic Breast Cancer Based Upon the Norton-Simon Mathematical Model
Baseline characteristics by cohort
| Measure |
Group 0
n=4 Participants
Capecitabine - AM 1500mg; PM 1500 mg; total daily 3000 mg
|
Group 1
n=3 Participants
Capecitabine - AM 1500 mg; PM 2000 mg; total daily 3500 mg
|
Group 2
n=50 Participants
Capecitabine - AM 2000 mg; PM 2000 mg; total daily 4000 mg
|
Group 3
n=6 Participants
Capecitabine - AM 2000 mg; PM 2500mg; total daily 4500 mg
|
Total
n=63 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
46 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
59 Participants
n=31 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=31 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
50 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
63 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: 2 yearsThis is defined as the percentage of patients who achieve either an objective complete or partial target lesion response that is confirmed based on the RECIST criteria.
Outcome measures
| Measure |
Group 0
n=3 Participants
Capecitabine - AM 1500mg; PM 1500 mg; total daily 3000 mg
|
Group 1
n=3 Participants
Capecitabine - AM 1500 mg; PM 2000 mg; total daily 3500 mg
|
Group 2
n=45 Participants
Capecitabine - AM 2000 mg; PM 2000 mg; total daily 4000 mg
|
Group 3
n=5 Participants
Capecitabine - AM 2000 mg; PM 2500mg; total daily 4500 mg
|
|---|---|---|---|---|
|
Overall Objective Response
Partial Response (PR)
|
0 participants
|
0 participants
|
8 participants
|
0 participants
|
|
Overall Objective Response
Stable Disease (SD)
|
2 participants
|
1 participants
|
22 participants
|
3 participants
|
|
Overall Objective Response
Progression of Disease (POD)
|
1 participants
|
2 participants
|
15 participants
|
2 participants
|
Adverse Events
Group 0
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Group 1
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Group 2
Serious events: 7 serious events
Other events: 41 other events
Deaths: 0 deaths
Group 3
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group 0
n=4 participants at risk
Capecitabine - AM 1500mg; PM 1500 mg; total daily 3000 mg
|
Group 1
n=3 participants at risk
Capecitabine - AM 1500 mg; PM 2000 mg; total daily 3500 mg
|
Group 2
n=50 participants at risk
Capecitabine - AM 2000 mg; PM 2000 mg; total daily 4000 mg
|
Group 3
n=6 participants at risk
Capecitabine - AM 2000 mg; PM 2500mg; total daily 4500 mg
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Dehydration
|
25.0%
1/4 • Number of events 1
|
0.00%
0/3
|
0.00%
0/50
|
0.00%
0/6
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
25.0%
1/4 • Number of events 1
|
0.00%
0/3
|
0.00%
0/50
|
0.00%
0/6
|
|
General disorders
Pain - Back
|
25.0%
1/4 • Number of events 1
|
0.00%
0/3
|
0.00%
0/50
|
0.00%
0/6
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/4
|
0.00%
0/3
|
2.0%
1/50 • Number of events 1
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
0.00%
0/4
|
0.00%
0/3
|
4.0%
2/50 • Number of events 2
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
Skin infection
|
0.00%
0/4
|
0.00%
0/3
|
2.0%
1/50 • Number of events 1
|
0.00%
0/6
|
|
Renal and urinary disorders
Urinary tract infection
|
0.00%
0/4
|
0.00%
0/3
|
2.0%
1/50 • Number of events 1
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Pericardial effusion
|
0.00%
0/4
|
0.00%
0/3
|
2.0%
1/50 • Number of events 1
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
Rash: hand-foot skin reaction
|
0.00%
0/4
|
0.00%
0/3
|
2.0%
1/50 • Number of events 1
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Thrombosis
|
0.00%
0/4
|
0.00%
0/3
|
2.0%
1/50 • Number of events 1
|
0.00%
0/6
|
Other adverse events
| Measure |
Group 0
n=4 participants at risk
Capecitabine - AM 1500mg; PM 1500 mg; total daily 3000 mg
|
Group 1
n=3 participants at risk
Capecitabine - AM 1500 mg; PM 2000 mg; total daily 3500 mg
|
Group 2
n=50 participants at risk
Capecitabine - AM 2000 mg; PM 2000 mg; total daily 4000 mg
|
Group 3
n=6 participants at risk
Capecitabine - AM 2000 mg; PM 2500mg; total daily 4500 mg
|
|---|---|---|---|---|
|
Metabolism and nutrition disorders
Alkaline phosphatase
|
0.00%
0/4
|
33.3%
1/3 • Number of events 1
|
6.0%
3/50 • Number of events 3
|
0.00%
0/6
|
|
Metabolism and nutrition disorders
ALT, SGPT
|
25.0%
1/4 • Number of events 1
|
0.00%
0/3
|
12.0%
6/50 • Number of events 6
|
0.00%
0/6
|
|
Metabolism and nutrition disorders
AST, SGOT
|
25.0%
1/4 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
20.0%
10/50 • Number of events 10
|
0.00%
0/6
|
|
Metabolism and nutrition disorders
Bilirubin (hyperbilirubinemia)
|
25.0%
1/4 • Number of events 1
|
0.00%
0/3
|
8.0%
4/50 • Number of events 4
|
33.3%
2/6 • Number of events 2
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/4
|
0.00%
0/3
|
6.0%
3/50 • Number of events 3
|
0.00%
0/6
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/4
|
33.3%
1/3 • Number of events 1
|
0.00%
0/50
|
16.7%
1/6 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/50
|
16.7%
1/6 • Number of events 1
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
0.00%
0/4
|
66.7%
2/3 • Number of events 2
|
14.0%
7/50 • Number of events 7
|
16.7%
1/6 • Number of events 1
|
|
Metabolism and nutrition disorders
Glucose, high (hyperglycemia)
|
50.0%
2/4 • Number of events 2
|
0.00%
0/3
|
28.0%
14/50 • Number of events 14
|
16.7%
1/6 • Number of events 1
|
|
Blood and lymphatic system disorders
Hemoglobin
|
0.00%
0/4
|
33.3%
1/3 • Number of events 1
|
10.0%
5/50 • Number of events 5
|
0.00%
0/6
|
|
General disorders
Hot flashes/flushes
|
25.0%
1/4 • Number of events 1
|
0.00%
0/3
|
0.00%
0/50
|
0.00%
0/6
|
|
Cardiac disorders
Hypertension
|
0.00%
0/4
|
0.00%
0/3
|
18.0%
9/50 • Number of events 9
|
0.00%
0/6
|
|
Infections and infestations
Infection, other
|
25.0%
1/4 • Number of events 1
|
0.00%
0/3
|
0.00%
0/50
|
0.00%
0/6
|
|
Blood and lymphatic system disorders
Leukocytes (total WBC)
|
25.0%
1/4 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
16.0%
8/50 • Number of events 8
|
0.00%
0/6
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/4
|
33.3%
1/3 • Number of events 1
|
0.00%
0/50
|
0.00%
0/6
|
|
Nervous system disorders
Neuropathy: sensory
|
0.00%
0/4
|
0.00%
0/3
|
10.0%
5/50 • Number of events 5
|
16.7%
1/6 • Number of events 1
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes (ANC/AGC)
|
25.0%
1/4 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
14.0%
7/50 • Number of events 7
|
0.00%
0/6
|
|
General disorders
Pain - Back
|
25.0%
1/4 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
0.00%
0/50
|
0.00%
0/6
|
|
General disorders
Pain - Chest wall
|
25.0%
1/4 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
0.00%
0/50
|
0.00%
0/6
|
|
General disorders
Pain - Extremity-limb
|
25.0%
1/4 • Number of events 1
|
0.00%
0/3
|
0.00%
0/50
|
0.00%
0/6
|
|
General disorders
Pain - Head/headache
|
0.00%
0/4
|
0.00%
0/3
|
8.0%
4/50 • Number of events 4
|
0.00%
0/6
|
|
General disorders
Pain - Other
|
25.0%
1/4 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
8.0%
4/50 • Number of events 4
|
16.7%
1/6 • Number of events 1
|
|
Metabolism and nutrition disorders
Phosphate, low (hypophosphatemia)
|
0.00%
0/4
|
33.3%
1/3 • Number of events 1
|
0.00%
0/50
|
0.00%
0/6
|
|
Metabolism and nutrition disorders
Potassium, high (hyperkalemia)
|
25.0%
1/4 • Number of events 1
|
0.00%
0/3
|
0.00%
0/50
|
16.7%
1/6 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash: hand-foot skin reaction
|
0.00%
0/4
|
33.3%
1/3 • Number of events 1
|
56.0%
28/50 • Number of events 28
|
50.0%
3/6 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Skin breakdown/decubitus ulcer
|
25.0%
1/4 • Number of events 1
|
0.00%
0/3
|
0.00%
0/50
|
0.00%
0/6
|
|
General disorders
Syncope (fainting)
|
25.0%
1/4 • Number of events 1
|
0.00%
0/3
|
0.00%
0/50
|
16.7%
1/6 • Number of events 1
|
|
Renal and urinary disorders
Urinary frequency/urgency
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/50
|
16.7%
1/6 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/4
|
33.3%
1/3 • Number of events 1
|
0.00%
0/50
|
0.00%
0/6
|
Additional Information
Dr. Tiffany Traina
Memorial Sloan Kettering Cancer Center
Phone: 646-888-4558
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place