Trial Outcomes & Findings for VEGF Trap in Treating Patients With Metastatic Breast Cancer (NCT NCT00369655)
NCT ID: NCT00369655
Last Updated: 2014-05-05
Results Overview
Confirmed tumor response was defined as the total number of efficacy-evaluable patients who achieved a complete or partial response according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria on 2 consecutive evaluations at least 8 weeks apart.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
21 participants
Primary outcome timeframe
Up to 5 years
Results posted on
2014-05-05
Participant Flow
Twenty-one women were enrolled during the first stage of the study between January 2007 and March 2008.
Participant milestones
| Measure |
Treatment (Ziv-afibercept)
Patients receive VEGF Trap IV over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Overall Study
STARTED
|
21
|
|
Overall Study
COMPLETED
|
19
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Treatment (Ziv-afibercept)
Patients receive VEGF Trap IV over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Overall Study
Refusal of further treatment
|
2
|
Baseline Characteristics
VEGF Trap in Treating Patients With Metastatic Breast Cancer
Baseline characteristics by cohort
| Measure |
Treatment (Ziv-afibercept)
n=21 Participants
Patients receive VEGF Trap IV over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Age, Continuous
|
58 years
n=99 Participants
|
|
Sex/Gender, Customized
Female
|
21 participants
n=99 Participants
|
|
Region of Enrollment
United States
|
21 participants
n=99 Participants
|
|
ECOG Performance Score
0-Fully active
|
14 Participants
n=99 Participants
|
|
ECOG Performance Score
1-Ambulatory, restricted strenuous activity
|
7 Participants
n=99 Participants
|
|
Cell type
Infiltrating ductal
|
16 Participants
n=99 Participants
|
|
Cell type
Infiltrating lobular
|
1 Participants
n=99 Participants
|
|
Cell type
Comedo
|
1 Participants
n=99 Participants
|
|
Cell type
Inflammatory
|
1 Participants
n=99 Participants
|
|
Cell type
Infiltrating ductal and comedo
|
1 Participants
n=99 Participants
|
|
Cell type
Missing
|
1 Participants
n=99 Participants
|
|
Dominant Disease
Visceral
|
15 Participants
n=99 Participants
|
|
Dominant Disease
Nonvisceral
|
6 Participants
n=99 Participants
|
|
Visceral Disease Site
Liver
|
7 Participants
n=99 Participants
|
|
Visceral Disease Site
Lung
|
7 Participants
n=99 Participants
|
|
Visceral Disease Site
Abodomen
|
1 Participants
n=99 Participants
|
|
Visceral Disease Site
Other
|
2 Participants
n=99 Participants
|
|
Estrogen Receptor (ER) Result
Positive
|
9 Participants
n=99 Participants
|
|
Estrogen Receptor (ER) Result
Negative
|
12 Participants
n=99 Participants
|
|
Progesterone Receptor (PR) Result
Positive
|
5 Participants
n=99 Participants
|
|
Progesterone Receptor (PR) Result
Negative
|
16 Participants
n=99 Participants
|
|
Human epidermal growth factor receptor 2 (HER2) Result
Positive
|
4 Participants
n=99 Participants
|
|
Human epidermal growth factor receptor 2 (HER2) Result
Negative
|
14 Participants
n=99 Participants
|
|
Human epidermal growth factor receptor 2 (HER2) Result
HER2 testing not done
|
3 Participants
n=99 Participants
|
|
Previous (Neo) Adjuvant Chemotherapy
Yes
|
13 Participants
n=99 Participants
|
|
Previous (Neo) Adjuvant Chemotherapy
No
|
8 Participants
n=99 Participants
|
|
Number of Previous Chemotherapy Regimens
0
|
3 Participants
n=99 Participants
|
|
Number of Previous Chemotherapy Regimens
1
|
11 Participants
n=99 Participants
|
|
Number of Previous Chemotherapy Regimens
2
|
7 Participants
n=99 Participants
|
|
Previous Hormonal Therapy
Yes
|
9 Participants
n=99 Participants
|
|
Previous Hormonal Therapy
No
|
12 Participants
n=99 Participants
|
|
Previous Trastuzumab
Yes
|
5 Participants
n=99 Participants
|
|
Previous Trastuzumab
No
|
16 Participants
n=99 Participants
|
|
Prior Anthracyclines
Yes
|
15 Participants
n=99 Participants
|
|
Prior Anthracyclines
No
|
6 Participants
n=99 Participants
|
|
Prior Taxanes
Yes
|
19 Participants
n=99 Participants
|
|
Prior Taxanes
No
|
2 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Up to 5 yearsPopulation: All participants who have met the eligibility criteria, who have signed a consent form and have begun treatment were evaluable for response.
Confirmed tumor response was defined as the total number of efficacy-evaluable patients who achieved a complete or partial response according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria on 2 consecutive evaluations at least 8 weeks apart.
Outcome measures
| Measure |
Treatment (Ziv-afibercept)
n=21 Participants
Patients receive VEGF Trap IV over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Proportion of Patients With Confirmed Tumor Response
Confirmed tumor partial response
|
1 Participants
|
|
Proportion of Patients With Confirmed Tumor Response
No Confirmed reponse
|
20 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: All participants who have met the eligibility criteria, who have signed a consent form and have begun treatment were evaluable for response.
The 6-month progression free survival rate was defined as the proportion of efficacy-evaluable patients on study treatment and progression-free 6 months from registration. Patients who died without documentation of progression will be considered to have progressed on the date of their death.
Outcome measures
| Measure |
Treatment (Ziv-afibercept)
n=21 Participants
Patients receive VEGF Trap IV over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Proportion of Patients Receiving Vascular Endothelial Growth Factor (VEGF) Trap With 6-month Progression-free Survival
|
2 Participants
|
SECONDARY outcome
Timeframe: Time from registration to disease progression or death (up to 5 years)Progression-free survival was defined as the number of months from registration to the date of disease progression or death, with patients who died without documentation of progression being considered to have progressed on the date of their death.
Outcome measures
| Measure |
Treatment (Ziv-afibercept)
n=21 Participants
Patients receive VEGF Trap IV over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Progression Free Survival
|
2.7 Months
Interval 1.8 to 5.0
|
SECONDARY outcome
Timeframe: Time from registration to death or last follow up (up to 5 years)Overall survival time was defined as the number of months from registration to the date of death or last follow-up
Outcome measures
| Measure |
Treatment (Ziv-afibercept)
n=21 Participants
Patients receive VEGF Trap IV over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Overall Survival
|
12.7 Months
Interval 6.7 to 31.1
|
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: Analysis population included only patients who have achieved a confirmed tumor response. The duration of response of 4.6 months is reported from one patient.
Duration of response was defined as for all evaluable patients who have achieved an objective response as the date at which the patient's objective status is first noted to be either a complete response or partial response to the date progression is documented.
Outcome measures
| Measure |
Treatment (Ziv-afibercept)
n=1 Participants
Patients receive VEGF Trap IV over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Median Duration of Response
|
4.6 Months
Interval 4.6 to 4.6
|
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: All participants who have received previous treatment with anti-HER2.
Outcome measures
| Measure |
Treatment (Ziv-afibercept)
n=5 Participants
Patients receive VEGF Trap IV over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Number of Participant With Previous Treatment of Anti-HER2 With Cardiac Events
|
1 Participants
|
Adverse Events
Treatment (Ziv-afibercept)
Serious events: 10 serious events
Other events: 21 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment (Ziv-afibercept)
n=21 participants at risk
Patients receive VEGF Trap IV over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Cardiac disorders
Left ventricular failure
|
9.5%
2/21 • Number of events 2 • Start of treatment to end of treatment
Common Toxicity Criteria for Adverse Events (CTCAE) v3
|
|
Cardiac disorders
Sinus tachycardia
|
4.8%
1/21 • Number of events 1 • Start of treatment to end of treatment
Common Toxicity Criteria for Adverse Events (CTCAE) v3
|
|
Gastrointestinal disorders
Abdominal pain
|
4.8%
1/21 • Number of events 1 • Start of treatment to end of treatment
Common Toxicity Criteria for Adverse Events (CTCAE) v3
|
|
General disorders
Disease progression
|
4.8%
1/21 • Number of events 1 • Start of treatment to end of treatment
Common Toxicity Criteria for Adverse Events (CTCAE) v3
|
|
Investigations
Platelet count decreased
|
4.8%
1/21 • Number of events 1 • Start of treatment to end of treatment
Common Toxicity Criteria for Adverse Events (CTCAE) v3
|
|
Metabolism and nutrition disorders
Anorexia
|
4.8%
1/21 • Number of events 1 • Start of treatment to end of treatment
Common Toxicity Criteria for Adverse Events (CTCAE) v3
|
|
Nervous system disorders
Headache
|
9.5%
2/21 • Number of events 2 • Start of treatment to end of treatment
Common Toxicity Criteria for Adverse Events (CTCAE) v3
|
|
Nervous system disorders
Ischemia cerebrovascular
|
4.8%
1/21 • Number of events 1 • Start of treatment to end of treatment
Common Toxicity Criteria for Adverse Events (CTCAE) v3
|
|
Renal and urinary disorders
Proteinuria
|
4.8%
1/21 • Number of events 1 • Start of treatment to end of treatment
Common Toxicity Criteria for Adverse Events (CTCAE) v3
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
9.5%
2/21 • Number of events 2 • Start of treatment to end of treatment
Common Toxicity Criteria for Adverse Events (CTCAE) v3
|
|
Vascular disorders
Hypertension
|
9.5%
2/21 • Number of events 2 • Start of treatment to end of treatment
Common Toxicity Criteria for Adverse Events (CTCAE) v3
|
Other adverse events
| Measure |
Treatment (Ziv-afibercept)
n=21 participants at risk
Patients receive VEGF Trap IV over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
9.5%
2/21 • Number of events 2 • Start of treatment to end of treatment
Common Toxicity Criteria for Adverse Events (CTCAE) v3
|
|
Eye disorders
Flashing vision
|
4.8%
1/21 • Number of events 1 • Start of treatment to end of treatment
Common Toxicity Criteria for Adverse Events (CTCAE) v3
|
|
Eye disorders
Vision blurred
|
14.3%
3/21 • Number of events 6 • Start of treatment to end of treatment
Common Toxicity Criteria for Adverse Events (CTCAE) v3
|
|
Gastrointestinal disorders
Abdominal pain
|
9.5%
2/21 • Number of events 2 • Start of treatment to end of treatment
Common Toxicity Criteria for Adverse Events (CTCAE) v3
|
|
Gastrointestinal disorders
Constipation
|
52.4%
11/21 • Number of events 25 • Start of treatment to end of treatment
Common Toxicity Criteria for Adverse Events (CTCAE) v3
|
|
Gastrointestinal disorders
Diarrhea
|
57.1%
12/21 • Number of events 19 • Start of treatment to end of treatment
Common Toxicity Criteria for Adverse Events (CTCAE) v3
|
|
Gastrointestinal disorders
Ear, nose and throat examination abnormal
|
9.5%
2/21 • Number of events 3 • Start of treatment to end of treatment
Common Toxicity Criteria for Adverse Events (CTCAE) v3
|
|
Gastrointestinal disorders
Mucositis oral
|
4.8%
1/21 • Number of events 2 • Start of treatment to end of treatment
Common Toxicity Criteria for Adverse Events (CTCAE) v3
|
|
Gastrointestinal disorders
Nausea
|
52.4%
11/21 • Number of events 23 • Start of treatment to end of treatment
Common Toxicity Criteria for Adverse Events (CTCAE) v3
|
|
Gastrointestinal disorders
Vomiting
|
42.9%
9/21 • Number of events 14 • Start of treatment to end of treatment
Common Toxicity Criteria for Adverse Events (CTCAE) v3
|
|
General disorders
Chest pain
|
42.9%
9/21 • Number of events 22 • Start of treatment to end of treatment
Common Toxicity Criteria for Adverse Events (CTCAE) v3
|
|
General disorders
Fatigue
|
100.0%
21/21 • Number of events 75 • Start of treatment to end of treatment
Common Toxicity Criteria for Adverse Events (CTCAE) v3
|
|
General disorders
Pain
|
9.5%
2/21 • Number of events 2 • Start of treatment to end of treatment
Common Toxicity Criteria for Adverse Events (CTCAE) v3
|
|
Immune system disorders
Cytokine release syndrome
|
4.8%
1/21 • Number of events 1 • Start of treatment to end of treatment
Common Toxicity Criteria for Adverse Events (CTCAE) v3
|
|
Immune system disorders
Hypersensitivity
|
4.8%
1/21 • Number of events 1 • Start of treatment to end of treatment
Common Toxicity Criteria for Adverse Events (CTCAE) v3
|
|
Infections and infestations
Pharyngitis
|
4.8%
1/21 • Number of events 1 • Start of treatment to end of treatment
Common Toxicity Criteria for Adverse Events (CTCAE) v3
|
|
Infections and infestations
Upper respiratory infection
|
4.8%
1/21 • Number of events 1 • Start of treatment to end of treatment
Common Toxicity Criteria for Adverse Events (CTCAE) v3
|
|
Investigations
Alanine aminotransferase increased
|
19.0%
4/21 • Number of events 6 • Start of treatment to end of treatment
Common Toxicity Criteria for Adverse Events (CTCAE) v3
|
|
Investigations
Alkaline phosphatase increased
|
28.6%
6/21 • Number of events 10 • Start of treatment to end of treatment
Common Toxicity Criteria for Adverse Events (CTCAE) v3
|
|
Investigations
Aspartate aminotransferase increased
|
19.0%
4/21 • Number of events 13 • Start of treatment to end of treatment
Common Toxicity Criteria for Adverse Events (CTCAE) v3
|
|
Investigations
Bilirubin increased
|
9.5%
2/21 • Number of events 3 • Start of treatment to end of treatment
Common Toxicity Criteria for Adverse Events (CTCAE) v3
|
|
Investigations
INR increased
|
4.8%
1/21 • Number of events 1 • Start of treatment to end of treatment
Common Toxicity Criteria for Adverse Events (CTCAE) v3
|
|
Investigations
Leukocyte count decreased
|
19.0%
4/21 • Number of events 7 • Start of treatment to end of treatment
Common Toxicity Criteria for Adverse Events (CTCAE) v3
|
|
Investigations
Neutrophil count decreased
|
9.5%
2/21 • Number of events 3 • Start of treatment to end of treatment
Common Toxicity Criteria for Adverse Events (CTCAE) v3
|
|
Investigations
Platelet count decreased
|
4.8%
1/21 • Number of events 1 • Start of treatment to end of treatment
Common Toxicity Criteria for Adverse Events (CTCAE) v3
|
|
Investigations
Weight loss
|
9.5%
2/21 • Number of events 2 • Start of treatment to end of treatment
Common Toxicity Criteria for Adverse Events (CTCAE) v3
|
|
Metabolism and nutrition disorders
Anorexia
|
42.9%
9/21 • Number of events 17 • Start of treatment to end of treatment
Common Toxicity Criteria for Adverse Events (CTCAE) v3
|
|
Metabolism and nutrition disorders
Dehydration
|
4.8%
1/21 • Number of events 1 • Start of treatment to end of treatment
Common Toxicity Criteria for Adverse Events (CTCAE) v3
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
4.8%
1/21 • Number of events 1 • Start of treatment to end of treatment
Common Toxicity Criteria for Adverse Events (CTCAE) v3
|
|
Metabolism and nutrition disorders
Hypokalemia
|
4.8%
1/21 • Number of events 1 • Start of treatment to end of treatment
Common Toxicity Criteria for Adverse Events (CTCAE) v3
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
38.1%
8/21 • Number of events 13 • Start of treatment to end of treatment
Common Toxicity Criteria for Adverse Events (CTCAE) v3
|
|
Musculoskeletal and connective tissue disorders
Joint pain
|
61.9%
13/21 • Number of events 26 • Start of treatment to end of treatment
Common Toxicity Criteria for Adverse Events (CTCAE) v3
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
57.1%
12/21 • Number of events 21 • Start of treatment to end of treatment
Common Toxicity Criteria for Adverse Events (CTCAE) v3
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
4.8%
1/21 • Number of events 1 • Start of treatment to end of treatment
Common Toxicity Criteria for Adverse Events (CTCAE) v3
|
|
Nervous system disorders
Ataxia
|
4.8%
1/21 • Number of events 1 • Start of treatment to end of treatment
Common Toxicity Criteria for Adverse Events (CTCAE) v3
|
|
Nervous system disorders
Dizziness
|
4.8%
1/21 • Number of events 1 • Start of treatment to end of treatment
Common Toxicity Criteria for Adverse Events (CTCAE) v3
|
|
Nervous system disorders
Headache
|
42.9%
9/21 • Number of events 23 • Start of treatment to end of treatment
Common Toxicity Criteria for Adverse Events (CTCAE) v3
|
|
Nervous system disorders
Memory impairment
|
4.8%
1/21 • Number of events 1 • Start of treatment to end of treatment
Common Toxicity Criteria for Adverse Events (CTCAE) v3
|
|
Psychiatric disorders
Depression
|
4.8%
1/21 • Number of events 3 • Start of treatment to end of treatment
Common Toxicity Criteria for Adverse Events (CTCAE) v3
|
|
Renal and urinary disorders
Proteinuria
|
23.8%
5/21 • Number of events 9 • Start of treatment to end of treatment
Common Toxicity Criteria for Adverse Events (CTCAE) v3
|
|
Renal and urinary disorders
Urethral pain
|
4.8%
1/21 • Number of events 1 • Start of treatment to end of treatment
Common Toxicity Criteria for Adverse Events (CTCAE) v3
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
4.8%
1/21 • Number of events 2 • Start of treatment to end of treatment
Common Toxicity Criteria for Adverse Events (CTCAE) v3
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
14.3%
3/21 • Number of events 7 • Start of treatment to end of treatment
Common Toxicity Criteria for Adverse Events (CTCAE) v3
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
42.9%
9/21 • Number of events 15 • Start of treatment to end of treatment
Common Toxicity Criteria for Adverse Events (CTCAE) v3
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage nasal
|
4.8%
1/21 • Number of events 2 • Start of treatment to end of treatment
Common Toxicity Criteria for Adverse Events (CTCAE) v3
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
14.3%
3/21 • Number of events 4 • Start of treatment to end of treatment
Common Toxicity Criteria for Adverse Events (CTCAE) v3
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
61.9%
13/21 • Number of events 44 • Start of treatment to end of treatment
Common Toxicity Criteria for Adverse Events (CTCAE) v3
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
4.8%
1/21 • Number of events 1 • Start of treatment to end of treatment
Common Toxicity Criteria for Adverse Events (CTCAE) v3
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
14.3%
3/21 • Number of events 4 • Start of treatment to end of treatment
Common Toxicity Criteria for Adverse Events (CTCAE) v3
|
|
Skin and subcutaneous tissue disorders
Hand-and-foot syndrome
|
4.8%
1/21 • Number of events 1 • Start of treatment to end of treatment
Common Toxicity Criteria for Adverse Events (CTCAE) v3
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
4.8%
1/21 • Number of events 1 • Start of treatment to end of treatment
Common Toxicity Criteria for Adverse Events (CTCAE) v3
|
|
Skin and subcutaneous tissue disorders
Rash desquamating
|
14.3%
3/21 • Number of events 4 • Start of treatment to end of treatment
Common Toxicity Criteria for Adverse Events (CTCAE) v3
|
|
Vascular disorders
Hypertension
|
57.1%
12/21 • Number of events 28 • Start of treatment to end of treatment
Common Toxicity Criteria for Adverse Events (CTCAE) v3
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60