Trial Outcomes & Findings for A Phase 2 Feasibility Study of Abraxane and Carboplatin in Epithelial Neoplasms of the Uterus (NCT NCT02744898)
NCT ID: NCT02744898
Last Updated: 2023-09-26
Results Overview
Tolerability for an individual patient will be defined as remaining on the study for 6 cycles with two or fewer dose reductions.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
23 participants
Primary outcome timeframe
24 months
Results posted on
2023-09-26
Participant Flow
Participant milestones
| Measure |
Carboplatin AUC and Abraxane 100mg/m2
Carboplatin AUC
Abraxane: 100mg/m2
|
|---|---|
|
Overall Study
STARTED
|
23
|
|
Overall Study
COMPLETED
|
19
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
Carboplatin AUC and Abraxane 100mg/m2
Carboplatin AUC
Abraxane: 100mg/m2
|
|---|---|
|
Overall Study
Progressive Disease
|
2
|
|
Overall Study
Physician Decision
|
1
|
|
Overall Study
Toxicity
|
1
|
Baseline Characteristics
A Phase 2 Feasibility Study of Abraxane and Carboplatin in Epithelial Neoplasms of the Uterus
Baseline characteristics by cohort
| Measure |
Carboplatin AUC and Abraxane 100mg/m2
n=23 Participants
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.
|
|---|---|
|
Age, Continuous
|
65 years
n=5 Participants
|
|
Sex/Gender, Customized
Female
|
23 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
19 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
23 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 monthsTolerability for an individual patient will be defined as remaining on the study for 6 cycles with two or fewer dose reductions.
Outcome measures
| Measure |
Carboplatin AUC and Abraxane 100mg/m2
n=19 Participants
Carboplatin AUC
Abraxane: 100mg/m2
|
|---|---|
|
Tolerability Measured Completion of Dose Regimen
|
16 Participants
|
SECONDARY outcome
Timeframe: Up to Month 24PFS 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.
Outcome measures
| Measure |
Carboplatin AUC and Abraxane 100mg/m2
n=23 Participants
Carboplatin AUC
Abraxane: 100mg/m2
|
|---|---|
|
Progression-Free Survival (PFS) at Month 24
|
28.2 Months
Interval 12.1 to
Not releasable (NR); insufficient number of participants with events.
|
SECONDARY outcome
Timeframe: Up to Month 24ORR 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
Outcome measures
| Measure |
Carboplatin AUC and Abraxane 100mg/m2
n=23 Participants
Carboplatin AUC
Abraxane: 100mg/m2
|
|---|---|
|
Objective Response Rate (ORR) as Measured by RECIST 1.1 at Month 24
|
33.3 Percentage of participants
Interval 7.5 to 70.1
|
Adverse Events
Carboplatin AUC and Abraxane 100mg/m2
Serious events: 3 serious events
Other events: 23 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Carboplatin AUC and Abraxane 100mg/m2
n=23 participants at risk
Carboplatin AUC
Abraxane: 100mg/m2
|
|---|---|
|
Renal and urinary disorders
Acute kidney injury
|
4.3%
1/23 • Number of events 1 • 24 Months
|
|
General disorders
Vomiting
|
4.3%
1/23 • Number of events 1 • 24 Months
|
|
General disorders
Dehydration
|
4.3%
1/23 • Number of events 1 • 24 Months
|
|
General disorders
Hypoalbuminemia
|
4.3%
1/23 • Number of events 1 • 24 Months
|
|
Blood and lymphatic system disorders
Lymphocyte count decreased
|
4.3%
1/23 • Number of events 1 • 24 Months
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
4.3%
1/23 • Number of events 1 • 24 Months
|
|
General disorders
Syncope
|
4.3%
1/23 • Number of events 1 • 24 Months
|
|
General disorders
Pain
|
4.3%
1/23 • Number of events 1 • 24 Months
|
|
General disorders
Myalgia
|
4.3%
1/23 • Number of events 1 • 24 Months
|
Other adverse events
| Measure |
Carboplatin AUC and Abraxane 100mg/m2
n=23 participants at risk
Carboplatin AUC
Abraxane: 100mg/m2
|
|---|---|
|
General disorders
Neutropenia
|
4.3%
1/23 • Number of events 1 • 24 Months
|
|
General disorders
Neutrophil Count Decreased
|
34.8%
8/23 • Number of events 8 • 24 Months
|
|
General disorders
Pain
|
17.4%
4/23 • Number of events 4 • 24 Months
|
|
General disorders
Pain (Tooth)
|
4.3%
1/23 • Number of events 1 • 24 Months
|
|
General disorders
Pain In Extremity
|
4.3%
1/23 • Number of events 1 • 24 Months
|
|
General disorders
Palpitations
|
4.3%
1/23 • Number of events 1 • 24 Months
|
|
General disorders
Paresthesia
|
21.7%
5/23 • Number of events 5 • 24 Months
|
|
General disorders
Pelvic Pain
|
21.7%
5/23 • Number of events 5 • 24 Months
|
|
General disorders
Peridontal Disease
|
4.3%
1/23 • Number of events 1 • 24 Months
|
|
General disorders
Peripheral Neuropathy
|
8.7%
2/23 • Number of events 2 • 24 Months
|
|
General disorders
Peripheral Sensory Neuropathy
|
8.7%
2/23 • Number of events 2 • 24 Months
|
|
General disorders
Photosensitivity
|
4.3%
1/23 • Number of events 1 • 24 Months
|
|
General disorders
Platelet Count
|
4.3%
1/23 • Number of events 1 • 24 Months
|
|
General disorders
Platelets Decresed
|
13.0%
3/23 • Number of events 3 • 24 Months
|
|
General disorders
Poor Venous Access
|
0.00%
0/23 • 24 Months
|
|
General disorders
Pruritis
|
4.3%
1/23 • Number of events 1 • 24 Months
|
|
General disorders
Rash Acneiform
|
4.3%
1/23 • Number of events 1 • 24 Months
|
|
Renal and urinary disorders
Renal And Urinary Disorders
|
4.3%
1/23 • Number of events 1 • 24 Months
|
|
General disorders
Right Leg Pain
|
4.3%
1/23 • Number of events 1 • 24 Months
|
|
General disorders
Scalp Rash
|
4.3%
1/23 • Number of events 1 • 24 Months
|
|
General disorders
Shortness Of Breath
|
8.7%
2/23 • Number of events 2 • 24 Months
|
|
General disorders
Skin And Subcutaneous Tissue Disorders
|
4.3%
1/23 • Number of events 1 • 24 Months
|
|
Skin and subcutaneous tissue disorders
Skin Hyperpigmentation
|
8.7%
2/23 • Number of events 2 • 24 Months
|
|
Skin and subcutaneous tissue disorders
Skin Infection
|
4.3%
1/23 • Number of events 1 • 24 Months
|
|
Infections and infestations
Small Intestinal Obstruction
|
4.3%
1/23 • Number of events 1 • 24 Months
|
|
General disorders
Syncope
|
4.3%
1/23 • Number of events 1 • 24 Months
|
|
General disorders
Tachycardia
|
8.7%
2/23 • Number of events 2 • 24 Months
|
|
General disorders
Thrombocytopenia
|
13.0%
3/23 • Number of events 3 • 24 Months
|
|
General disorders
Thromboembolic Event
|
8.7%
2/23 • Number of events 2 • 24 Months
|
|
General disorders
Toothache
|
4.3%
1/23 • Number of events 1 • 24 Months
|
|
General disorders
Total Bilirubin Elevated
|
8.7%
2/23 • Number of events 2 • 24 Months
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Infection
|
21.7%
5/23 • Number of events 5 • 24 Months
|
|
General disorders
Urinary Frequency
|
8.7%
2/23 • Number of events 2 • 24 Months
|
|
General disorders
Urinary Urgency
|
8.7%
2/23 • Number of events 2 • 24 Months
|
|
General disorders
Vomiting
|
13.0%
3/23 • Number of events 3 • 24 Months
|
|
General disorders
Wbc Decreased
|
4.3%
1/23 • Number of events 1 • 24 Months
|
|
General disorders
Weight Loss
|
4.3%
1/23 • Number of events 1 • 24 Months
|
|
General disorders
White Blood Cells Decreased
|
39.1%
9/23 • Number of events 9 • 24 Months
|
|
General disorders
Wound Complication
|
4.3%
1/23 • Number of events 23 • 24 Months
|
|
General disorders
Right Leg Swelling
|
4.3%
1/23 • Number of events 1 • 24 Months
|
|
Gastrointestinal disorders
Abdominal Pain
|
17.4%
4/23 • Number of events 4 • 24 Months
|
|
Blood and lymphatic system disorders
Absolute Neutrophilous Count Decreased
|
4.3%
1/23 • Number of events 1 • 24 Months
|
|
Renal and urinary disorders
Acute Kidney Injury
|
4.3%
1/23 • Number of events 1 • 24 Months
|
|
Renal and urinary disorders
Alanine Aminotransferase Increased
|
21.7%
5/23 • Number of events 5 • 24 Months
|
|
Blood and lymphatic system disorders
Alkaline Phosphatase Elevated
|
4.3%
1/23 • Number of events 1 • 24 Months
|
|
Blood and lymphatic system disorders
Alkaline Phosphatase Increased
|
26.1%
6/23 • Number of events 6 • 24 Months
|
|
General disorders
Allergic Reaction
|
4.3%
1/23 • Number of events 1 • 24 Months
|
|
Congenital, familial and genetic disorders
Alopecia
|
69.6%
16/23 • Number of events 16 • 24 Months
|
|
Blood and lymphatic system disorders
Alt Increased
|
13.0%
3/23 • Number of events 3 • 24 Months
|
|
Blood and lymphatic system disorders
Anc Decreased
|
8.7%
2/23 • Number of events 2 • 24 Months
|
|
Blood and lymphatic system disorders
Anemia
|
87.0%
20/23 • Number of events 20 • 24 Months
|
|
Psychiatric disorders
Anorexia
|
47.8%
11/23 • Number of events 11 • 24 Months
|
|
Psychiatric disorders
Anxiety
|
13.0%
3/23 • Number of events 3 • 24 Months
|
|
Psychiatric disorders
Arthralgia
|
13.0%
3/23 • Number of events 3 • 24 Months
|
|
Blood and lymphatic system disorders
Aspartate Aminotransferase Increased
|
30.4%
7/23 • Number of events 7 • 24 Months
|
|
Blood and lymphatic system disorders
Ast Increased
|
13.0%
3/23 • Number of events 3 • 24 Months
|
|
Cardiac disorders
B/L Deep Vein Thrombosis
|
4.3%
1/23 • Number of events 1 • 24 Months
|
|
Respiratory, thoracic and mediastinal disorders
B/L Pleural Effusion
|
4.3%
1/23 • Number of events 1 • 24 Months
|
|
Injury, poisoning and procedural complications
Back Pain
|
4.3%
1/23 • Number of events 1 • 24 Months
|
|
Blood and lymphatic system disorders
Blood Bilirubin Increased
|
4.3%
1/23 • Number of events 1 • 24 Months
|
|
General disorders
Body Aches(Myalgias)
|
4.3%
1/23 • Number of events 1 • 24 Months
|
|
General disorders
Chest Pain
|
4.3%
1/23 • Number of events 1 • 24 Months
|
|
Metabolism and nutrition disorders
Colitis
|
4.3%
1/23 • Number of events 1 • 24 Months
|
|
General disorders
Constipation
|
47.8%
11/23 • Number of events 11 • 24 Months
|
|
General disorders
Cough
|
4.3%
1/23 • Number of events 1 • 24 Months
|
|
General disorders
Cough/Clear Sputum
|
4.3%
1/23 • Number of events 1 • 24 Months
|
|
Hepatobiliary disorders
Creatinine Increased
|
17.4%
4/23 • Number of events 4 • 24 Months
|
|
Blood and lymphatic system disorders
Decreased Anc
|
8.7%
2/23 • Number of events 2 • 24 Months
|
|
Blood and lymphatic system disorders
Decreased Neutrolphil Count
|
13.0%
3/23 • Number of events 3 • 24 Months
|
|
Blood and lymphatic system disorders
Decreased Platelet Count
|
13.0%
3/23 • Number of events 3 • 24 Months
|
|
General disorders
Decreased Sodium
|
4.3%
1/23 • Number of events 1 • 24 Months
|
|
Blood and lymphatic system disorders
Decreased White Blood Cell Count
|
26.1%
6/23 • Number of events 6 • 24 Months
|
|
General disorders
Dehydration
|
17.4%
4/23 • Number of events 4 • 24 Months
|
|
General disorders
Diarrhea
|
43.5%
10/23 • Number of events 10 • 24 Months
|
|
General disorders
Dizziness
|
17.4%
4/23 • Number of events 4 • 24 Months
|
|
General disorders
Dry Skin
|
4.3%
1/23 • Number of events 1 • 24 Months
|
|
General disorders
Dyseusia
|
4.3%
1/23 • Number of events 1 • 24 Months
|
|
General disorders
Dysgeusia
|
13.0%
3/23 • Number of events 3 • 24 Months
|
|
General disorders
Dyspepsia
|
4.3%
1/23 • Number of events 1 • 24 Months
|
|
General disorders
Dyspnea
|
8.7%
2/23 • Number of events 2 • 24 Months
|
|
General disorders
Ear Infection
|
0.00%
0/23 • 24 Months
|
|
General disorders
Edema Limbs
|
8.7%
2/23 • Number of events 2 • 24 Months
|
|
Blood and lymphatic system disorders
Elevated Alkaline Phosphatase
|
4.3%
1/23 • Number of events 1 • 24 Months
|
|
Blood and lymphatic system disorders
Elevated Alt
|
8.7%
2/23 • Number of events 2 • 24 Months
|
|
Blood and lymphatic system disorders
Elevated Creatinine
|
4.3%
1/23 • Number of events 1 • 24 Months
|
|
Blood and lymphatic system disorders
Elevated Potassium
|
8.7%
2/23 • Number of events 2 • 24 Months
|
|
Blood and lymphatic system disorders
Elevated Total Bilirubin
|
4.3%
1/23 • Number of events 1 • 24 Months
|
|
General disorders
Epistaxis
|
4.3%
1/23 • Number of events 1 • 24 Months
|
|
Eye disorders
Eye Disorders
|
4.3%
1/23 • Number of events 1 • 24 Months
|
|
General disorders
Facial Flushing
|
4.3%
1/23 • Number of events 1 • 24 Months
|
|
General disorders
Fall
|
4.3%
1/23 • Number of events 1 • 24 Months
|
|
General disorders
Fatigue
|
69.6%
16/23 • Number of events 16 • 24 Months
|
|
General disorders
Flu Like Symptoms
|
4.3%
1/23 • Number of events 1 • 24 Months
|
|
General disorders
Gastroesophageal Reflux Disease 22
|
4.3%
1/23 • Number of events 1 • 24 Months
|
|
General disorders
Generalized Weakness
|
4.3%
1/23 • Number of events 1 • 24 Months
|
|
General disorders
Gi Distress/Abdominal
|
4.3%
1/23 • Number of events 1 • 24 Months
|
|
General disorders
Gingival Pain
|
4.3%
1/23 • Number of events 1 • 24 Months
|
|
General disorders
Gum Infection
|
4.3%
1/23 • Number of events 1 • 24 Months
|
|
General disorders
Headache
|
8.7%
2/23 • Number of events 2 • 24 Months
|
|
General disorders
Hot Flashes
|
4.3%
1/23 • Number of events 1 • 24 Months
|
|
General disorders
Hypercalcemia
|
4.3%
1/23 • Number of events 1 • 24 Months
|
|
General disorders
Hyperkalemia
|
4.3%
1/23 • Number of events 1 • 24 Months
|
|
General disorders
Hypernatremia
|
17.4%
4/23 • Number of events 4 • 24 Months
|
|
General disorders
Hypertension
|
4.3%
1/23 • Number of events 1 • 24 Months
|
|
General disorders
Hypoalbuminemia
|
4.3%
1/23 • Number of events 1 • 24 Months
|
|
General disorders
Hypocalcemia
|
4.3%
1/23 • Number of events 1 • 24 Months
|
|
General disorders
Hypokalemia
|
30.4%
7/23 • Number of events 7 • 24 Months
|
|
General disorders
Hypomagnesemia
|
8.7%
2/23 • Number of events 2 • 24 Months
|
|
General disorders
Increased Alkaline Phospatase Level
|
4.3%
1/23 • Number of events 1 • 24 Months
|
|
General disorders
Increased Alkaline Phosphatase
|
4.3%
1/23 • Number of events 1 • 24 Months
|
|
General disorders
Injection Site Reaction
|
4.3%
1/23 • Number of events 1 • 24 Months
|
|
General disorders
Insomnia
|
8.7%
2/23 • Number of events 2 • 24 Months
|
|
General disorders
Intermittent Abdominal Pain
|
4.3%
1/23 • Number of events 1 • 24 Months
|
|
General disorders
Intermittent Anorexia
|
4.3%
1/23 • Number of events 1 • 24 Months
|
|
General disorders
Intermittent Blurred Vision
|
4.3%
1/23 • Number of events 1 • 24 Months
|
|
General disorders
Intermittent Decreased Platelets
|
4.3%
1/23 • Number of events 1 • 24 Months
|
|
General disorders
Intermittent Diarrhea
|
4.3%
1/23 • Number of events 1 • 24 Months
|
|
General disorders
Intermittent Dysgeusia
|
4.3%
1/23 • Number of events 1 • 24 Months
|
|
General disorders
Intermittent Fatigue
|
8.7%
2/23 • Number of events 2 • 24 Months
|
|
General disorders
Intermittent Hyperglycemia
|
4.3%
1/23 • Number of events 1 • 24 Months
|
|
General disorders
Intermittent Myalgias
|
4.3%
1/23 • Number of events 1 • 24 Months
|
|
General disorders
Intermittent Nausea
|
30.4%
7/23 • Number of events 7 • 24 Months
|
|
General disorders
L E Edema
|
4.3%
1/23 • Number of events 1 • 24 Months
|
|
General disorders
Le Edema
|
4.3%
1/23 • Number of events 1 • 24 Months
|
|
General disorders
Left Arm Pain
|
4.3%
1/23 • Number of events 1 • 24 Months
|
|
General disorders
Left Quadrant Pain
|
4.3%
1/23 • Number of events 1 • 24 Months
|
|
General disorders
Left-Hand Neuropathy
|
4.3%
1/23 • Number of events 1 • 24 Months
|
|
General disorders
Leukocytosis
|
4.3%
1/23 • Number of events 1 • 24 Months
|
|
General disorders
Leukopenia
|
4.3%
1/23 • Number of events 1 • 24 Months
|
|
General disorders
Low White Blood Cell Count
|
4.3%
1/23 • Number of events 1 • 24 Months
|
|
General disorders
Lymphocyte Count Decreased
|
17.4%
4/23 • Number of events 4 • 24 Months
|
|
General disorders
Memory Impairment
|
4.3%
1/23 • Number of events 1 • 24 Months
|
|
General disorders
Menorrhagia
|
4.3%
1/23 • Number of events 1 • 24 Months
|
|
General disorders
Mucositis Oral
|
4.3%
1/23 • Number of events 1 • 24 Months
|
|
General disorders
Muscle Weakness Upper Limb
|
4.3%
1/23 • Number of events 1 • 24 Months
|
|
General disorders
Musculoskeletal And Connective Tissue Disorder
|
0.00%
0/23 • 24 Months
|
|
General disorders
Musculoskeletal Pain
|
4.3%
1/23 • Number of events 1 • 24 Months
|
|
General disorders
Myalgia
|
17.4%
4/23 • Number of events 4 • 24 Months
|
|
General disorders
Nail Discoloration
|
8.7%
2/23 • Number of events 2 • 24 Months
|
|
General disorders
Nail Infection
|
4.3%
1/23 • Number of events 1 • 24 Months
|
|
General disorders
Nail Loss
|
4.3%
1/23 • Number of events 1 • 24 Months
|
|
General disorders
Nasal Congestion
|
4.3%
1/23 • Number of events 1 • 24 Months
|
|
General disorders
Nausea
|
52.2%
12/23 • Number of events 12 • 24 Months
|
|
General disorders
Neck Pain
|
4.3%
1/23 • Number of events 1 • 24 Months
|
|
General disorders
Neuotrophil Count Decreased
|
4.3%
1/23 • Number of events 1 • 24 Months
|
|
General disorders
Neuropathy
|
4.3%
1/23 • Number of events 1 • 24 Months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place