Trial Outcomes & Findings for Phase II Study of Carboplatin and Bevacizumab (Avastin) for ER Neg, PR Neg, and HER2/Neu Neg Metastatic Breast Cancer (NCT NCT00517361)
NCT ID: NCT00517361
Last Updated: 2014-04-15
Results Overview
Progression is defined using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee \[JNCI 92(3):205-216, 2000\], as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions, or appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.
TERMINATED
PHASE2
11 participants
Up to 5 years
2014-04-15
Participant Flow
Participant milestones
| Measure |
Carboplatin + Avastin
Carboplatin in 250mL saline IV over 30 minutes and Avastin (Bevacizumab) 15mg/kg in 100mL saline IV over 60 - 90 minutes
|
|---|---|
|
Overall Study
STARTED
|
11
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
11
|
Reasons for withdrawal
| Measure |
Carboplatin + Avastin
Carboplatin in 250mL saline IV over 30 minutes and Avastin (Bevacizumab) 15mg/kg in 100mL saline IV over 60 - 90 minutes
|
|---|---|
|
Overall Study
Death
|
6
|
|
Overall Study
The study was terminated
|
5
|
Baseline Characteristics
Phase II Study of Carboplatin and Bevacizumab (Avastin) for ER Neg, PR Neg, and HER2/Neu Neg Metastatic Breast Cancer
Baseline characteristics by cohort
| Measure |
Carboplatin + Avastin
n=11 Participants
Carboplatin in 250mL saline IV over 30 minutes and Avastin (Bevacizumab) 15mg/kg in 100mL saline IV over 60 - 90 minutes
|
|---|---|
|
Age, Continuous
|
47.7 years
STANDARD_DEVIATION 12 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 5 yearsPopulation: This study has been terminated due to poor accrual.
Progression is defined using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee \[JNCI 92(3):205-216, 2000\], as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions, or appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: This study has been terminated due to poor accrual.
Response is defined using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee \[JNCI 92(3):205-216, 2000\]: Complete Response (CR), Disappearance of all target lesions or disappearance of all non-target lesions and normalization of tumor marker level; Partial Response (PR), At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD; Stable Disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum LD since the treatment started, or persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: This study has been terminated due to poor accrual.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: This study has been terminated due to poor accrual.
The methylation status of the tumor is defined using Methylation Specific polymerase chain reaction and/or pyrosequencing.
Outcome measures
Outcome data not reported
Adverse Events
Carboplatin + Avastin
Serious adverse events
| Measure |
Carboplatin + Avastin
n=11 participants at risk
Carboplatin in 250mL saline IV over 30 minutes and Avastin (Bevacizumab) 15mg/kg in 100mL saline IV over 60 - 90 minutes
|
|---|---|
|
General disorders
nausea
|
9.1%
1/11 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
9.1%
1/11 • Number of events 1
|
|
General disorders
pain
|
9.1%
1/11 • Number of events 1
|
|
Nervous system disorders
severe weakness
|
9.1%
1/11 • Number of events 1
|
Other adverse events
| Measure |
Carboplatin + Avastin
n=11 participants at risk
Carboplatin in 250mL saline IV over 30 minutes and Avastin (Bevacizumab) 15mg/kg in 100mL saline IV over 60 - 90 minutes
|
|---|---|
|
Blood and lymphatic system disorders
Leukopenia
|
9.1%
1/11 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
9.1%
1/11 • Number of events 1
|
|
Gastrointestinal disorders
nausea
|
36.4%
4/11 • Number of events 4
|
|
Gastrointestinal disorders
Vomiting
|
18.2%
2/11 • Number of events 2
|
|
General disorders
Chest pain
|
9.1%
1/11 • Number of events 1
|
|
General disorders
Fatigue
|
45.5%
5/11 • Number of events 5
|
|
General disorders
pain
|
9.1%
1/11 • Number of events 1
|
|
Investigations
Alanine aminotransferase increased
|
27.3%
3/11 • Number of events 3
|
|
Investigations
Alkaline phosphatase increased
|
18.2%
2/11 • Number of events 2
|
|
Investigations
Aspartate aminotransferase increased
|
27.3%
3/11 • Number of events 3
|
|
Investigations
Creatinine increased
|
9.1%
1/11 • Number of events 1
|
|
Investigations
Ear, nose and throat examination abnormal
|
9.1%
1/11 • Number of events 1
|
|
Investigations
Hemoglobin
|
18.2%
2/11 • Number of events 2
|
|
Investigations
Hemoglobin decreased
|
18.2%
2/11 • Number of events 2
|
|
Investigations
Hyperglycemia
|
9.1%
1/11 • Number of events 1
|
|
Investigations
Laboratory test abnormal
|
9.1%
1/11 • Number of events 1
|
|
Investigations
Leukocytes
|
27.3%
3/11 • Number of events 3
|
|
Investigations
Neutrophil count decreased
|
18.2%
2/11 • Number of events 2
|
|
Investigations
Neutrophils
|
27.3%
3/11 • Number of events 3
|
|
Investigations
Platelet count decreased
|
18.2%
2/11 • Number of events 2
|
|
Investigations
Platelets
|
54.5%
6/11 • Number of events 6
|
|
Investigations
Weight loss
|
9.1%
1/11 • Number of events 1
|
|
Metabolism and nutrition disorders
Anorexia
|
9.1%
1/11 • Number of events 1
|
|
Metabolism and nutrition disorders
Dehydration
|
9.1%
1/11 • Number of events 1
|
|
Nervous system disorders
Headache
|
18.2%
2/11 • Number of events 2
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
18.2%
2/11 • Number of events 2
|
|
Psychiatric disorders
Depression
|
9.1%
1/11 • Number of events 1
|
|
Psychiatric disorders
Insomnia
|
18.2%
2/11 • Number of events 2
|
|
Renal and urinary disorders
Proteinuria
|
9.1%
1/11 • Number of events 1
|
|
Reproductive system and breast disorders
Breast pain
|
9.1%
1/11 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary hemorrhage
|
9.1%
1/11 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage nasal
|
27.3%
3/11 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
9.1%
1/11 • Number of events 1
|
|
Vascular disorders
Hemorrhage - Other (Specify)
|
9.1%
1/11 • Number of events 1
|
|
Vascular disorders
Hypertension
|
27.3%
3/11 • Number of events 3
|
|
Vascular disorders
Vascular - Other (Specify)
|
9.1%
1/11 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place