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The purpose of this study is to evaluate the safety of treatment with carboplatin and Abraxane in this patient population and determine the nature and degree of toxicities following treatment. The single stage open label Phase II feasibility study is designed to estimate the proportion of patients who can tolerate the proposed regimen for 6 cycles with no more than two dose level reductions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Carboplatin AUC and Abraxane 100mg/m2 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Carboplatin AUC | Drug |
| ||
| Abraxane |
| Measure | Description | Time Frame |
|---|---|---|
| Tolerability Measured Completion of Dose Regimen | Tolerability for an individual patient will be defined as remaining on the study for 6 cycles with two or fewer dose reductions. | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) at Month 24 | PFS is defined as the time from first dosing to the first observation of disease progression or death due to any cause. PFS was estimated beyond the collected data using Kaplan Meier methods. | Up to Month 24 |
| Objective Response Rate (ORR) as Measured by RECIST 1.1 at Month 24 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Franco Muggia, MD | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Perlmutter Cancer Center | New York | New York | 10016 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Carboplatin AUC and Abraxane 100mg/m2 | Carboplatin AUC Abraxane: 100mg/m2 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
1-MD Decision
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| ID | Title | Description |
|---|---|---|
| BG000 | Carboplatin AUC and Abraxane 100mg/m2 | Approximately 23 patients will be enrolled in this study at the Laura & Isaac Perlmutter Cancer Center at NYU Langone.There is a total of 17 study visits, including the screening visit to determine if you are eligible to participate. This study will be an out-patient 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 |
| 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 | Tolerability Measured Completion of Dose Regimen | Tolerability for an individual patient will be defined as remaining on the study for 6 cycles with two or fewer dose reductions. | Posted | Count of Participants | Participants | 24 months |
|
|
24 Months
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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 | Carboplatin AUC and Abraxane 100mg/m2 | Carboplatin AUC Abraxane: 100mg/m2 | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute kidney injury | Renal and urinary disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Pain | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Franco Muggia, MD | NYU Langone Health | 212 263 2172 | Franco.Muggia@nyulangone.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 19, 2017 | Aug 9, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D016889 | Endometrial Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D000068196 | Albumin-Bound Paclitaxel |
| D017239 | Paclitaxel |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
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100mg/m2 |
|
|
ORR is the number of patients whose best tumor response outcome by Month 24 is a Complete Response (CR) or Partial Response (PR), divided by the total number of evaluable patients. Per the Response Evaluation Criteria in Solid Tumors (RECIST v1.1.): CR = Disappearance of all target lesions; PR = At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD |
| Up to Month 24 |
| years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
| Secondary | Progression-Free Survival (PFS) at Month 24 | PFS is defined as the time from first dosing to the first observation of disease progression or death due to any cause. PFS was estimated beyond the collected data using Kaplan Meier methods. | Posted | Median | 95% Confidence Interval | Months | Up to Month 24 |
|
|
|
| Secondary | Objective Response Rate (ORR) as Measured by RECIST 1.1 at Month 24 | ORR is the number of patients whose best tumor response outcome by Month 24 is a Complete Response (CR) or Partial Response (PR), divided by the total number of evaluable patients. Per the Response Evaluation Criteria in Solid Tumors (RECIST v1.1.): CR = Disappearance of all target lesions; PR = At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD | Posted | Number | 95% Confidence Interval | Percentage of participants | Up to Month 24 |
|
|
|
| 23 |
| 3 |
| 23 |
| 23 |
| 23 |
| Vomiting | General disorders | Non-systematic Assessment |
|
| Dehydration | General disorders | Non-systematic Assessment |
|
| Hypoalbuminemia | General disorders | Non-systematic Assessment |
|
| Lymphocyte count decreased | Blood and lymphatic system disorders | Systematic Assessment |
|
| Small intestinal obstruction | Gastrointestinal disorders | Systematic Assessment |
|
| Syncope | General disorders | Non-systematic Assessment |
|
| Pain | General disorders | Non-systematic Assessment |
|
| Myalgia | General disorders | Non-systematic Assessment |
|
| Absolute Neutrophilous Count Decreased | Blood and lymphatic system disorders | Systematic Assessment |
|
| Acute Kidney Injury | Renal and urinary disorders | Systematic Assessment |
|
| Alanine Aminotransferase Increased | Renal and urinary disorders | Systematic Assessment |
|
| Alkaline Phosphatase Elevated | Blood and lymphatic system disorders | Systematic Assessment |
|
| Alkaline Phosphatase Increased | Blood and lymphatic system disorders | Systematic Assessment |
|
| Allergic Reaction | General disorders | Systematic Assessment |
|
| Alopecia | Congenital, familial and genetic disorders | Systematic Assessment |
|
| Alt Increased | Blood and lymphatic system disorders | Systematic Assessment |
|
| Anc Decreased | Blood and lymphatic system disorders | Systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Anorexia | Psychiatric disorders | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | Systematic Assessment |
|
| Arthralgia | Psychiatric disorders | Systematic Assessment |
|
| Aspartate Aminotransferase Increased | Blood and lymphatic system disorders | Systematic Assessment |
|
| Ast Increased | Blood and lymphatic system disorders | Systematic Assessment |
|
| B/L Deep Vein Thrombosis | Cardiac disorders | Systematic Assessment |
|
| B/L Pleural Effusion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Back Pain | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Blood Bilirubin Increased | Blood and lymphatic system disorders | Systematic Assessment |
|
| Body Aches(Myalgias) | General disorders | Non-systematic Assessment |
|
| Chest Pain | General disorders | Non-systematic Assessment |
|
| Colitis | Metabolism and nutrition disorders | Systematic Assessment |
|
| Constipation | General disorders | Non-systematic Assessment |
|
| Cough | General disorders | Non-systematic Assessment |
|
| Cough/Clear Sputum | General disorders | Non-systematic Assessment |
|
| Creatinine Increased | Hepatobiliary disorders | Systematic Assessment |
|
| Decreased Anc | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Decreased Neutrolphil Count | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Decreased Platelet Count | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Decreased Sodium | General disorders | Non-systematic Assessment |
|
| Decreased White Blood Cell Count | Blood and lymphatic system disorders | Systematic Assessment |
|
| Dehydration | General disorders | Non-systematic Assessment |
|
| Diarrhea | General disorders | Non-systematic Assessment |
|
| Dizziness | General disorders | Non-systematic Assessment |
|
| Dry Skin | General disorders | Non-systematic Assessment |
|
| Dyseusia | General disorders | Non-systematic Assessment |
|
| Dysgeusia | General disorders | Non-systematic Assessment |
|
| Dyspepsia | General disorders | Non-systematic Assessment |
|
| Dyspnea | General disorders | Non-systematic Assessment |
|
| Ear Infection | General disorders | Non-systematic Assessment |
|
| Edema Limbs | General disorders | Non-systematic Assessment |
|
| Elevated Alkaline Phosphatase | Blood and lymphatic system disorders | Systematic Assessment |
|
| Elevated Alt | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Elevated Creatinine | Blood and lymphatic system disorders | Systematic Assessment |
|
| Elevated Potassium | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Elevated Total Bilirubin | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Epistaxis | General disorders | Systematic Assessment |
|
| Eye Disorders | Eye disorders | Systematic Assessment |
|
| Facial Flushing | General disorders | Non-systematic Assessment |
|
| Fall | General disorders | Non-systematic Assessment |
|
| Fatigue | General disorders | Non-systematic Assessment |
|
| Flu Like Symptoms | General disorders | Non-systematic Assessment |
|
| Gastroesophageal Reflux Disease 22 | General disorders | Non-systematic Assessment |
|
| Generalized Weakness | General disorders | Non-systematic Assessment |
|
| Gi Distress/Abdominal | General disorders | Non-systematic Assessment |
|
| Gingival Pain | General disorders | Non-systematic Assessment |
|
| Gum Infection | General disorders | Non-systematic Assessment |
|
| Headache | General disorders | Non-systematic Assessment |
|
| Hot Flashes | General disorders | Non-systematic Assessment |
|
| Hypercalcemia | General disorders | Non-systematic Assessment |
|
| Hyperkalemia | General disorders | Non-systematic Assessment |
|
| Hypernatremia | General disorders | Non-systematic Assessment |
|
| Hypertension | General disorders | Non-systematic Assessment |
|
| Hypoalbuminemia | General disorders | Non-systematic Assessment |
|
| Hypocalcemia | General disorders | Non-systematic Assessment |
|
| Hypokalemia | General disorders | Non-systematic Assessment |
|
| Hypomagnesemia | General disorders | Non-systematic Assessment |
|
| Increased Alkaline Phospatase Level | General disorders | Non-systematic Assessment |
|
| Increased Alkaline Phosphatase | General disorders | Non-systematic Assessment |
|
| Injection Site Reaction | General disorders | Non-systematic Assessment |
|
| Insomnia | General disorders | Non-systematic Assessment |
|
| Intermittent Abdominal Pain | General disorders | Non-systematic Assessment |
|
| Intermittent Anorexia | General disorders | Non-systematic Assessment |
|
| Intermittent Blurred Vision | General disorders | Non-systematic Assessment |
|
| Intermittent Decreased Platelets | General disorders | Non-systematic Assessment |
|
| Intermittent Diarrhea | General disorders | Non-systematic Assessment |
|
| Intermittent Dysgeusia | General disorders | Non-systematic Assessment |
|
| Intermittent Fatigue | General disorders | Non-systematic Assessment |
|
| Intermittent Hyperglycemia | General disorders | Non-systematic Assessment |
|
| Intermittent Myalgias | General disorders | Non-systematic Assessment |
|
| Intermittent Nausea | General disorders | Non-systematic Assessment |
|
| L E Edema | General disorders | Non-systematic Assessment |
|
| Le Edema | General disorders | Non-systematic Assessment |
|
| Left Arm Pain | General disorders | Non-systematic Assessment |
|
| Left Quadrant Pain | General disorders | Non-systematic Assessment |
|
| Left-Hand Neuropathy | General disorders | Non-systematic Assessment |
|
| Leukocytosis | General disorders | Non-systematic Assessment |
|
| Leukopenia | General disorders | Non-systematic Assessment |
|
| Low White Blood Cell Count | General disorders | Non-systematic Assessment |
|
| Lymphocyte Count Decreased | General disorders | Non-systematic Assessment |
|
| Memory Impairment | General disorders | Non-systematic Assessment |
|
| Menorrhagia | General disorders | Non-systematic Assessment |
|
| Mucositis Oral | General disorders | Non-systematic Assessment |
|
| Muscle Weakness Upper Limb | General disorders | Non-systematic Assessment |
|
| Musculoskeletal And Connective Tissue Disorder | General disorders | Non-systematic Assessment |
|
| Musculoskeletal Pain | General disorders | Non-systematic Assessment |
|
| Myalgia | General disorders | Non-systematic Assessment |
|
| Nail Discoloration | General disorders | Non-systematic Assessment |
|
| Nail Infection | General disorders | Non-systematic Assessment |
|
| Nail Loss | General disorders | Non-systematic Assessment |
|
| Nasal Congestion | General disorders | Non-systematic Assessment |
|
| Nausea | General disorders | Non-systematic Assessment |
|
| Neck Pain | General disorders | Non-systematic Assessment |
|
| Neuotrophil Count Decreased | General disorders | Non-systematic Assessment |
|
| Neuropathy | General disorders | Non-systematic Assessment |
|
| Neutropenia | General disorders | Non-systematic Assessment |
|
| Neutrophil Count Decreased | General disorders | Non-systematic Assessment |
|
| Pain | General disorders | Non-systematic Assessment |
|
| Pain (Tooth) | General disorders | Non-systematic Assessment |
|
| Pain In Extremity | General disorders | Non-systematic Assessment |
|
| Palpitations | General disorders | Non-systematic Assessment |
|
| Paresthesia | General disorders | Non-systematic Assessment |
|
| Pelvic Pain | General disorders | Non-systematic Assessment |
|
| Peridontal Disease | General disorders | Non-systematic Assessment |
|
| Peripheral Neuropathy | General disorders | Non-systematic Assessment |
|
| Peripheral Sensory Neuropathy | General disorders | Non-systematic Assessment |
|
| Photosensitivity | General disorders | Non-systematic Assessment |
|
| Platelet Count | General disorders | Non-systematic Assessment |
|
| Platelets Decresed | General disorders | Non-systematic Assessment |
|
| Poor Venous Access | General disorders | Non-systematic Assessment |
|
| Pruritis | General disorders | Non-systematic Assessment |
|
| Rash Acneiform | General disorders | Non-systematic Assessment |
|
| Renal And Urinary Disorders | Renal and urinary disorders | Systematic Assessment |
|
| Right Leg Pain | General disorders | Non-systematic Assessment |
|
| Scalp Rash | General disorders | Non-systematic Assessment |
|
| Shortness Of Breath | General disorders | Non-systematic Assessment |
|
| Skin And Subcutaneous Tissue Disorders | General disorders | Non-systematic Assessment |
|
| Skin Hyperpigmentation | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Skin Infection | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Small Intestinal Obstruction | Infections and infestations | Systematic Assessment |
|
| Syncope | General disorders | Non-systematic Assessment |
|
| Tachycardia | General disorders | Non-systematic Assessment |
|
| Thrombocytopenia | General disorders | Non-systematic Assessment |
|
| Thromboembolic Event | General disorders | Non-systematic Assessment |
|
| Toothache | General disorders | Non-systematic Assessment |
|
| Total Bilirubin Elevated | General disorders | Non-systematic Assessment |
|
| Upper Respiratory Infection | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Urinary Frequency | General disorders | Non-systematic Assessment |
|
| Urinary Urgency | General disorders | Non-systematic Assessment |
|
| Vomiting | General disorders | Non-systematic Assessment |
|
| Wbc Decreased | General disorders | Non-systematic Assessment |
|
| Weight Loss | General disorders | Non-systematic Assessment |
|
| White Blood Cells Decreased | General disorders | Non-systematic Assessment |
|
| Wound Complication | General disorders | Non-systematic Assessment |
|
| Right Leg Swelling | General disorders | Non-systematic Assessment |
|
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| D009369 |
| Neoplasms |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D000418 | Albumins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |