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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2009-01257 | Other Identifier | CTRP | |
| CCCWFU74108 | Other Identifier | Wake Forest University Health Sciences |
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Slow accrual
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RATIONALE: Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as panitumumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Other find tumor cells and help kill them or carry tumor-killing substances to them. Giving panitumumab together with paclitaxel and carboplatin may be a better way to block tumor growth.
PURPOSE: This phase II trial is studying the side effects and how well paclitaxel and carboplatin together with panitumumab works in treating patients with metastatic triple negative breast cancer.
PRIMARY OBJECTIVE:
I. To determine the response rate to the combination of carboplatin, paclitaxel and panitumumab in women with ER-, PR- and Her-2 negative metastatic breast cancer.
SECONDARY OBJECTIVES:
I. To determine the tolerability and toxicities of the combination of paclitaxel, carboplatin and panitumumab.
II. To determine the markers that co-occur with EGFR expression in the triple negative breast cancer.
III. To assess the association between tumor biomarkers and clinical outcomes (response and survival).
IV. To examine the effect this regimen has on time to progression and survival.
OUTLINE:
Patients receive paclitaxel IV and carboplatin IV on days 1, 8, and 15. Patients also receive panitumumab IV on days 1 and 15. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | Patients receive paclitaxel IV and carboplatin IV on days 1, 8, and 15. Patients also receive panitumumab IV on days 1 and 15. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| panitumumab | Biological | Given IV |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Antitumor Activity as Assessed by Objective Tumor Response According to RECIST Criteria | Complete or Partial response as defined by reduction in tumor size according to RECIST (Response Evaluation Criteria In Solid Tumors) rules. | every 28 days for a minimum of 84 days |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Progression | Progression 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. | Approximately 7 months |
| Survival |
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Inclusion
Exclusion
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| Name | Affiliation | Role |
|---|---|---|
| Heidi D Klepin | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ochsner Clinic Foundation | New Orleans | Louisiana | 70115 | United States | ||
| Wake Forest University Health Sciences |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| paclitaxel | Drug | Given IV |
|
|
| carboplatin | Drug | Given IV |
|
|
| laboratory biomarker analysis | Procedure | Correlative study |
|
| immunohistochemistry staining method | Procedure | Correlative study |
|
|
| Approximately 7 months |
| Expression of EGFR and Other Protein Markers | baseline |
| Winston-Salem |
| North Carolina |
| 27157 |
| United States |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Antitumor Activity as Assessed by Objective Tumor Response According to RECIST Criteria | Complete or Partial response as defined by reduction in tumor size according to RECIST (Response Evaluation Criteria In Solid Tumors) rules. | Posted | Number | participants | every 28 days for a minimum of 84 days |
|
|
| |||||||||||||||||||||||||||
| Secondary | Time to Progression | Progression 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. | Posted | Median | 95% Confidence Interval | months | Approximately 7 months |
|
| |||||||||||||||||||||||||||
| Secondary | Survival | Posted | Median | 95% Confidence Interval | months | Approximately 7 months |
|
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| |||||||||||||||||||||||||||
| Secondary | Expression of EGFR and Other Protein Markers | Test not completed as specified in protocol that will only be completed if a full sample was accrued. | Posted | baseline |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 | 9 | 14 | 14 | 14 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Low WBC | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| low Platelets | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Low Hemoglobin | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Alkaline phosphatase | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Hypotension | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Neuropathy: sensory | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Neuropathy: motor | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Low ANC | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| hyperglycemia | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| hypoglycemia | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| hypocalcemia | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| hypomagnesemia | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| hypokalemia | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| hypoalbuminemia | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Thrombosis/thrombus/embolism | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
| |
| serum glutamic oxaloacetic transaminase | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Dehydration | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pruritus/itching | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain: Breast | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Lymphopenia | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Pain: Extremity-limb | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Urinary with low grade neutropenia | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| blurred vision | Eye disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Death not associated with CTCAE term: Disease progression NOS | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Mucositis/stomatitis Oral cavity | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Hemorrhage, GI: Upper GI | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Low WBC | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| low Platelets | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Low Hemoglobin | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Anorexia | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Alkaline phosphatase | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Creatinine | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Proteinuria | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Hair loss | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypertension | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypotension | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Neuropathy: sensory | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Neuropathy: motor | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Low ANC | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Pain | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dizziness | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Taste alteration | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dermatology/Skin | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Rigors/chills | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Fatigue | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Weight loss | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| hyperglycemia | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| hypocalcemia | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| hypomagnesemia | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| hyponatremia | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| hypokalemia | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Hot flashes/flushes | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Bicarbonate serum-low | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| hypoalbuminemia | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| hyperbilirubinemia | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| serum glutamic pyruvic transaminase | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| hypophosphatemia | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain: Head/headache | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Thrombosis/thrombus/embolism | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
| |
| serum glutamic oxaloacetic transaminase | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| hypermagnesemia | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Ocular/Visual - Other | Eye disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Fever without neutropenia | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Urinary frequency/urgency | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Infection - Other | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Edema: limb | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Speech impairment | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dehydration | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pruritus/itching | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Anxiety | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Depression | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Rash/desquamation | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain: Abdomen | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Rash: acne/acneiform | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Partial Thromboplastin Time | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Pain: Joint | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Ataxia | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain: Back | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain: Bone | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain: Breast | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain: Chest/thorax | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain: Chest wall | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Wound complication, non-infectious | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hemorrhage respiratory | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Rash: erythema multiforme | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Extremity-lower (gait/walking) | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Glomerular filtration rate | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Hemorrhoids | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Voice changes | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Rash: hand-foot skin reaction | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Lymphopenia | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Memory impairment | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Muscle weakness | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain: Muscle | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Nail changes | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain: Extremity-limb | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Palpitations | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Vision-flashing lights/floaters | Eye disorders | CTCAE (3.0) | Systematic Assessment |
| |
| International Normalized Ratio of prothrombin time | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Hemorrhage, GI: Rectum | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain: Kidney | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Allergic rhinitis | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hyperpigmentation | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Mucositis/stomatitis Oral cavity | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Pain: Urethra | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hemorrhage Bladder | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Urinary with low grade neutropenia | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Lymphatics - Other | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Mucositis/stomatitis Oral cavity | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection with unknown ANC Lung (pneumonia) | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Laryngeal nerve dysfunction | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Syndromes - Other | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| hypocalcemia | Investigations | CTCAE (3.0) | Systematic Assessment |
|
the worst adverse event of each type was recorded for the course of treatment
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Susan Melin | Wake Forest University Health Sciences | 336-716-2839 | smelin@wakehealth.edu |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D064726 | Triple Negative Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D000077544 | Panitumumab |
| D017239 | Paclitaxel |
| D013660 | Taxes |
| D016190 | Carboplatin |
| D007150 | Immunohistochemistry |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D004467 | Economics |
| D004472 | Health Care Economics and Organizations |
| D056831 | Coordination Complexes |
| D006651 | Histocytochemistry |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D006652 | Histological Techniques |
| D008919 | Investigative Techniques |
| D007158 | Immunologic Techniques |
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| >=65 years |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Unknown or Not Reported |
|
|
| Denominators |
|---|
| Categories |
|---|
|