Trial Outcomes & Findings for Paclitaxel, Carboplatin, and Panitumumab in Treating Patients With Metastatic Breast Cancer (NCT NCT01009983)
NCT ID: NCT01009983
Last Updated: 2018-07-06
Results Overview
Complete or Partial response as defined by reduction in tumor size according to RECIST (Response Evaluation Criteria In Solid Tumors) rules.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
14 participants
Primary outcome timeframe
every 28 days for a minimum of 84 days
Results posted on
2018-07-06
Participant Flow
Participant milestones
| Measure |
Arm 1
Patients receive paclitaxel IV and carboplatin IV on days 1, 8, and 15. Patients also receive panitumumab IV on days 1 and 15.
panitumumab: Given IV
paclitaxel: Given IV
carboplatin: Given IV
laboratory biomarker analysis: Correlative study
immunohistochemistry staining method: Correlative study
|
|---|---|
|
Overall Study
STARTED
|
14
|
|
Overall Study
COMPLETED
|
13
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Arm 1
Patients receive paclitaxel IV and carboplatin IV on days 1, 8, and 15. Patients also receive panitumumab IV on days 1 and 15.
panitumumab: Given IV
paclitaxel: Given IV
carboplatin: Given IV
laboratory biomarker analysis: Correlative study
immunohistochemistry staining method: Correlative study
|
|---|---|
|
Overall Study
necessary scans not completed
|
1
|
Baseline Characteristics
Paclitaxel, Carboplatin, and Panitumumab in Treating Patients With Metastatic Breast Cancer
Baseline characteristics by cohort
| Measure |
Arm 1
n=14 Participants
Patients receive paclitaxel IV and carboplatin IV on days 1, 8, and 15. Patients also receive panitumumab IV on days 1 and 15.
panitumumab: Given IV
paclitaxel: Given IV
carboplatin: Given IV
laboratory biomarker analysis: Correlative study
immunohistochemistry staining method: Correlative study
|
|---|---|
|
Age, Continuous
|
54.5 years
STANDARD_DEVIATION 10.1 • n=39 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=39 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=39 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=39 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=39 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=39 Participants
|
PRIMARY outcome
Timeframe: every 28 days for a minimum of 84 daysComplete or Partial response as defined by reduction in tumor size according to RECIST (Response Evaluation Criteria In Solid Tumors) rules.
Outcome measures
| Measure |
Arm 1
n=13 Participants
Patients receive paclitaxel IV and carboplatin IV on days 1, 8, and 15. Patients also receive panitumumab IV on days 1 and 15.
panitumumab: Given IV
paclitaxel: Given IV
carboplatin: Given IV
laboratory biomarker analysis: Correlative study
immunohistochemistry staining method: Correlative study
|
|---|---|
|
Antitumor Activity as Assessed by Objective Tumor Response According to RECIST Criteria
|
6 participants
|
SECONDARY outcome
Timeframe: Approximately 7 monthsProgression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Outcome measures
| Measure |
Arm 1
n=14 Participants
Patients receive paclitaxel IV and carboplatin IV on days 1, 8, and 15. Patients also receive panitumumab IV on days 1 and 15.
panitumumab: Given IV
paclitaxel: Given IV
carboplatin: Given IV
laboratory biomarker analysis: Correlative study
immunohistochemistry staining method: Correlative study
|
|---|---|
|
Time to Progression
|
5.3 months
Interval 2.2 to 5.8
|
SECONDARY outcome
Timeframe: Approximately 7 monthsOutcome measures
| Measure |
Arm 1
n=14 Participants
Patients receive paclitaxel IV and carboplatin IV on days 1, 8, and 15. Patients also receive panitumumab IV on days 1 and 15.
panitumumab: Given IV
paclitaxel: Given IV
carboplatin: Given IV
laboratory biomarker analysis: Correlative study
immunohistochemistry staining method: Correlative study
|
|---|---|
|
Survival
|
6.8 months
Interval 3.1 to
Due to calculation of confidence interval, the upper bound is not estimated because not enough of the sample had an event.
|
SECONDARY outcome
Timeframe: baselinePopulation: Test not completed as specified in protocol that will only be completed if a full sample was accrued.
Outcome measures
Outcome data not reported
Adverse Events
Arm 1
Serious events: 9 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm 1
n=14 participants at risk
Patients receive paclitaxel IV and carboplatin IV on days 1, 8, and 15. Patients also receive panitumumab IV on days 1 and 15.
panitumumab: Given IV
paclitaxel: Given IV
carboplatin: Given IV
laboratory biomarker analysis: Correlative study
immunohistochemistry staining method: Correlative study
|
|---|---|
|
Investigations
Low WBC
|
28.6%
4/14 • Number of events 4
|
|
Investigations
low Platelets
|
7.1%
1/14 • Number of events 1
|
|
Investigations
Low Hemoglobin
|
14.3%
2/14 • Number of events 2
|
|
Gastrointestinal disorders
Diarrhea
|
14.3%
2/14 • Number of events 2
|
|
Investigations
Alkaline phosphatase
|
7.1%
1/14 • Number of events 1
|
|
Cardiac disorders
Hypotension
|
7.1%
1/14 • Number of events 1
|
|
Cardiac disorders
Neuropathy: sensory
|
7.1%
1/14 • Number of events 1
|
|
Nervous system disorders
Neuropathy: motor
|
7.1%
1/14 • Number of events 1
|
|
Investigations
Low ANC
|
64.3%
9/14 • Number of events 9
|
|
Investigations
hyperglycemia
|
14.3%
2/14 • Number of events 2
|
|
Investigations
hypoglycemia
|
7.1%
1/14 • Number of events 1
|
|
Investigations
hypocalcemia
|
14.3%
2/14 • Number of events 2
|
|
Investigations
hypomagnesemia
|
14.3%
2/14 • Number of events 2
|
|
Investigations
hypokalemia
|
7.1%
1/14 • Number of events 1
|
|
Investigations
hypoalbuminemia
|
7.1%
1/14 • Number of events 1
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
14.3%
2/14 • Number of events 2
|
|
Investigations
serum glutamic oxaloacetic transaminase
|
7.1%
1/14 • Number of events 1
|
|
General disorders
Dehydration
|
7.1%
1/14 • Number of events 1
|
|
General disorders
Pruritus/itching
|
7.1%
1/14 • Number of events 1
|
|
General disorders
Pain: Breast
|
7.1%
1/14 • Number of events 1
|
|
Investigations
Lymphopenia
|
35.7%
5/14 • Number of events 5
|
|
General disorders
Pain: Extremity-limb
|
7.1%
1/14 • Number of events 1
|
|
Infections and infestations
Urinary with low grade neutropenia
|
7.1%
1/14 • Number of events 1
|
|
Eye disorders
blurred vision
|
7.1%
1/14 • Number of events 1
|
|
General disorders
Death not associated with CTCAE term: Disease progression NOS
|
7.1%
1/14 • Number of events 1
|
|
Infections and infestations
Mucositis/stomatitis Oral cavity
|
14.3%
2/14 • Number of events 2
|
|
Blood and lymphatic system disorders
Hemorrhage, GI: Upper GI
|
7.1%
1/14 • Number of events 1
|
Other adverse events
| Measure |
Arm 1
n=14 participants at risk
Patients receive paclitaxel IV and carboplatin IV on days 1, 8, and 15. Patients also receive panitumumab IV on days 1 and 15.
panitumumab: Given IV
paclitaxel: Given IV
carboplatin: Given IV
laboratory biomarker analysis: Correlative study
immunohistochemistry staining method: Correlative study
|
|---|---|
|
Investigations
Low WBC
|
50.0%
7/14 • Number of events 7
|
|
Investigations
low Platelets
|
71.4%
10/14 • Number of events 10
|
|
Investigations
Low Hemoglobin
|
85.7%
12/14 • Number of events 12
|
|
Gastrointestinal disorders
Nausea
|
50.0%
7/14 • Number of events 7
|
|
Gastrointestinal disorders
Vomiting
|
35.7%
5/14 • Number of events 5
|
|
Gastrointestinal disorders
Diarrhea
|
21.4%
3/14 • Number of events 3
|
|
General disorders
Anorexia
|
14.3%
2/14 • Number of events 2
|
|
Investigations
Alkaline phosphatase
|
57.1%
8/14 • Number of events 8
|
|
Investigations
Creatinine
|
7.1%
1/14 • Number of events 1
|
|
Investigations
Proteinuria
|
21.4%
3/14 • Number of events 3
|
|
General disorders
Hair loss
|
42.9%
6/14 • Number of events 6
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
35.7%
5/14 • Number of events 5
|
|
General disorders
Hypertension
|
14.3%
2/14 • Number of events 2
|
|
Cardiac disorders
Hypotension
|
35.7%
5/14 • Number of events 5
|
|
Cardiac disorders
Neuropathy: sensory
|
57.1%
8/14 • Number of events 8
|
|
Nervous system disorders
Neuropathy: motor
|
14.3%
2/14 • Number of events 2
|
|
Investigations
Low ANC
|
35.7%
5/14 • Number of events 5
|
|
General disorders
Pain
|
7.1%
1/14 • Number of events 1
|
|
General disorders
Dizziness
|
28.6%
4/14 • Number of events 4
|
|
General disorders
Taste alteration
|
7.1%
1/14 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin
|
28.6%
4/14 • Number of events 4
|
|
General disorders
Rigors/chills
|
7.1%
1/14 • Number of events 1
|
|
General disorders
Fatigue
|
57.1%
8/14 • Number of events 8
|
|
General disorders
Weight loss
|
21.4%
3/14 • Number of events 3
|
|
Investigations
hyperglycemia
|
64.3%
9/14 • Number of events 9
|
|
Investigations
hypocalcemia
|
7.1%
1/14 • Number of events 1
|
|
Investigations
hypomagnesemia
|
78.6%
11/14 • Number of events 11
|
|
Investigations
hyponatremia
|
21.4%
3/14 • Number of events 3
|
|
Investigations
hypokalemia
|
64.3%
9/14 • Number of events 9
|
|
General disorders
Hot flashes/flushes
|
7.1%
1/14 • Number of events 1
|
|
Investigations
Bicarbonate serum-low
|
7.1%
1/14 • Number of events 1
|
|
Investigations
hypoalbuminemia
|
42.9%
6/14 • Number of events 6
|
|
Investigations
hyperbilirubinemia
|
28.6%
4/14 • Number of events 4
|
|
Investigations
serum glutamic pyruvic transaminase
|
42.9%
6/14 • Number of events 6
|
|
Investigations
hypophosphatemia
|
14.3%
2/14 • Number of events 2
|
|
Gastrointestinal disorders
Constipation
|
57.1%
8/14 • Number of events 8
|
|
General disorders
Pain: Head/headache
|
14.3%
2/14 • Number of events 2
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
7.1%
1/14 • Number of events 1
|
|
Investigations
serum glutamic oxaloacetic transaminase
|
28.6%
4/14 • Number of events 4
|
|
Investigations
hypermagnesemia
|
7.1%
1/14 • Number of events 1
|
|
Eye disorders
Ocular/Visual - Other
|
7.1%
1/14 • Number of events 1
|
|
General disorders
Fever without neutropenia
|
28.6%
4/14 • Number of events 4
|
|
General disorders
Urinary frequency/urgency
|
7.1%
1/14 • Number of events 1
|
|
Infections and infestations
Infection - Other
|
14.3%
2/14 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
14.3%
2/14 • Number of events 2
|
|
Vascular disorders
Edema: limb
|
7.1%
1/14 • Number of events 1
|
|
General disorders
Speech impairment
|
7.1%
1/14 • Number of events 1
|
|
General disorders
Dehydration
|
14.3%
2/14 • Number of events 2
|
|
General disorders
Pruritus/itching
|
7.1%
1/14 • Number of events 1
|
|
General disorders
Anxiety
|
14.3%
2/14 • Number of events 2
|
|
General disorders
Depression
|
14.3%
2/14 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
28.6%
4/14 • Number of events 4
|
|
General disorders
Pain: Abdomen
|
21.4%
3/14 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Rash: acne/acneiform
|
50.0%
7/14 • Number of events 7
|
|
Investigations
Partial Thromboplastin Time
|
7.1%
1/14 • Number of events 1
|
|
General disorders
Pain: Joint
|
7.1%
1/14 • Number of events 1
|
|
General disorders
Ataxia
|
7.1%
1/14 • Number of events 1
|
|
General disorders
Pain: Back
|
21.4%
3/14 • Number of events 3
|
|
General disorders
Pain: Bone
|
7.1%
1/14 • Number of events 1
|
|
General disorders
Pain: Breast
|
7.1%
1/14 • Number of events 1
|
|
General disorders
Pain: Chest/thorax
|
7.1%
1/14 • Number of events 1
|
|
General disorders
Pain: Chest wall
|
7.1%
1/14 • Number of events 1
|
|
General disorders
Wound complication, non-infectious
|
14.3%
2/14 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
28.6%
4/14 • Number of events 4
|
|
Vascular disorders
Hemorrhage respiratory
|
7.1%
1/14 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash: erythema multiforme
|
14.3%
2/14 • Number of events 2
|
|
General disorders
Extremity-lower (gait/walking)
|
7.1%
1/14 • Number of events 1
|
|
Investigations
Glomerular filtration rate
|
7.1%
1/14 • Number of events 1
|
|
Gastrointestinal disorders
Hemorrhoids
|
7.1%
1/14 • Number of events 1
|
|
General disorders
Voice changes
|
7.1%
1/14 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash: hand-foot skin reaction
|
21.4%
3/14 • Number of events 3
|
|
Investigations
Lymphopenia
|
42.9%
6/14 • Number of events 6
|
|
General disorders
Memory impairment
|
7.1%
1/14 • Number of events 1
|
|
General disorders
Muscle weakness
|
7.1%
1/14 • Number of events 1
|
|
General disorders
Pain: Muscle
|
28.6%
4/14 • Number of events 5
|
|
General disorders
Nail changes
|
14.3%
2/14 • Number of events 2
|
|
General disorders
Pain: Extremity-limb
|
14.3%
2/14 • Number of events 2
|
|
General disorders
Palpitations
|
7.1%
1/14 • Number of events 1
|
|
Eye disorders
Vision-flashing lights/floaters
|
14.3%
2/14 • Number of events 2
|
|
Investigations
International Normalized Ratio of prothrombin time
|
7.1%
1/14 • Number of events 1
|
|
Blood and lymphatic system disorders
Hemorrhage, GI: Rectum
|
7.1%
1/14 • Number of events 1
|
|
General disorders
Pain: Kidney
|
7.1%
1/14 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Allergic rhinitis
|
21.4%
3/14 • Number of events 3
|
|
Cardiac disorders
Sinus tachycardia
|
42.9%
6/14 • Number of events 6
|
|
General disorders
Hyperpigmentation
|
7.1%
1/14 • Number of events 1
|
|
Infections and infestations
Mucositis/stomatitis Oral cavity
|
50.0%
7/14 • Number of events 7
|
|
General disorders
Pain: Urethra
|
7.1%
1/14 • Number of events 1
|
|
Vascular disorders
Hemorrhage Bladder
|
7.1%
1/14 • Number of events 1
|
|
Infections and infestations
Urinary with low grade neutropenia
|
7.1%
1/14 • Number of events 1
|
|
Blood and lymphatic system disorders
Lymphatics - Other
|
7.1%
1/14 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Infection with unknown ANC Lung (pneumonia)
|
7.1%
1/14 • Number of events 1
|
|
Nervous system disorders
Laryngeal nerve dysfunction
|
7.1%
1/14 • Number of events 1
|
|
General disorders
Syndromes - Other
|
7.1%
1/14 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place