A Phase 2 Feasibility Study of Abraxane and Carboplatin in Epithelial Neoplasms of the Uterus

• Sponsor: NYU Langone Health (Other)
• Overall Status: Completed
• CT.gov ID: NCT02744898
• Collaborator: (none)
• Enrollment: 23
• Location: 1
• Arm: 1
• Actual Duration (Months): 44
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Endometrial Cancer	Drug: Carboplatin AUC; Drug: Abraxane	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 23 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase 2 Feasibility Study of Abraxane and Carboplatin in Epithelial Neoplasms of the Uterus
• Actual Study Start Date: Jul 1, 2016
• Actual Primary Completion Date: Aug 17, 2018
• Actual Study Completion Date: Mar 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Carboplatin AUC and Abraxane 100mg/m2	Drug: Carboplatin AUC; Drug: Abraxane; 100mg/m2; Other Names: Paclitaxel

Outcome Measures

Primary Outcome Measures

1. Tolerability Measured Completion of Dose Regimen [24 months]

   Tolerability for an individual patient will be defined as remaining on the study for 6 cycles with two or fewer dose reductions.

Secondary Outcome Measures

1. Survival [60 months]

   This will be measured by the Kaplan-Meier curve and progression free survival rates

2. Percent Progression Free Survival [60 months]

   This will be measured by the Kaplan-Meier curve and progression free survival rates.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Female patients must have high risk resected stage I disease (papillary serous histology, clear cell histology or carcinosarcoma), advanced stage (III or IV, all histologies) or recurrent endometrial cancer (all histologies). Patients do not need measurable disease and can enroll following surgery.

• Patients may not have received prior cytotoxic chemotherapy. However, nonplatinum/non-taxane chemotherapy used for radiation sensitization is allowed. Patients may have received prior radiation therapy (including whole pelvic or vaginal brachytherapy), hormonal therapy, or therapy with biologic agents, but such therapy must be discontinued at least 2 weeks prior to entry on this study.

• If patients underwent surgery, and chemotherapy is indicated after surgery either as adjuvant or to treat residual disease, study treatment should be initiated within 8 weeks of surgery.

• In patients who have received prior radiation, at least 4 weeks should have elapsed since the completion of radiation therapy involving the whole pelvis or over 50% of the spine. If vaginal brachytherapy is planned with chemotherapy, it should be done before or after completion of chemotherapy treatment.

• Poorly differentiated histology, uterine papillary serous carcinoma, clear cell carcinoma or carcinosarcoma is acceptable as long as the predominant metastatic component is epithelial (versus sarcomatous).

• Patients may have synchronous endometrial and ovarian cancer primaries.

• Patients must have a GOG performance status of 0, 1, or 2

• Patients must be at least 18 years of age.

• Patients must understand and willingly sign an approved informed consent, and authorization permitting release of personal health information.

• Patients must have adequate liver function: AST and ALT ≤ 2.5 X upper limit of normal (ULN), and bilirubin ≤ 1.5mg/dL.

• Patients must have adequate bone marrow function: platelets ≥ 100,000 cells/mm3 (transfusion independent, defined as not receiving platelet transfusions within 7 days prior to laboratory sample), hemoglobin > 9.0g/dl and ANC ≥ 1,500 cells/mm3.

• Patients must have adequate renal function: creatinine < 1.5 mg/dL is recommended; however, institutional norms are acceptable.

• Patients must have < grade 2 pre-existing peripheral neuropathy (per CTCAE).

Exclusion Criteria:

• Other prior malignancies within 3 years, except non-melanoma skin cancers and synchronous ovarian primaries.

• Eligibility to a higher priority trial for first line or recurrent endometrial cancer (unless patient is unwilling to participate in such a trial).

• Patients with concomitant medical illness such as serious uncontrolled infection, or uncontrolled angina, which in the opinion of the treating physician, make the treatments prescribed on this study unreasonably hazardous for the patient.

• Patients who are pregnant or breastfeeding.

• Patients with third degree or complete heart block are not eligible unless a pacemaker is in place. Patients on medications, which alter cardiac conduction, such as digitalis, beta-blockers, or calcium channel blockers, or who have other conduction abnormalities or cardiac dysfunction could be entered at the discretion of the investigators.

• Patients with history of myocardial infarct within 6 months before enrollment, New York Heart Association (NYHA) class II or greater heart failure or symptoms suspicious for congestive heart failure are not eligible unless a LVEF in the past 6 months is documented to be 50% or greater. Patients who have had a LVEF (performed for any reason) that is less than 50% in the past 6 months are ineligible.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	NYU Perlmutter Cancer Center	New York	New York	United States	10016

Sponsors and Collaborators

• NYU Langone Health

Investigators

• Principal Investigator: Franco Muggia, MD, NYU Langone Health

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Dec 19, 2017

More Information

Publications

None provided.

• Responsible Party: NYU Langone Health
• ClinicalTrials.gov Identifier: NCT02744898
• Other Study ID Numbers: 15-01156
• First Posted: Apr 20, 2016
• Last Update Posted: May 11, 2021
• Last Verified: Apr 1, 2021

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by NYU Langone Health: uterus; gynecological; corpus uteri
• Additional relevant MeSH terms: Neoplasms; Endometrial Neoplasms; Neoplasms, Glandular and Epithelial; Uterine Neoplasms; Paclitaxel; Carboplatin; Albumin-Bound Paclitaxel

Study Results

Participant Flow

Arm/Group Title	Carboplatin AUC and Abraxane 100mg/m2
Arm/Group Description	Carboplatin AUC Abraxane: 100mg/m2
Period Title: Overall Study
STARTED	23
COMPLETED	19
NOT COMPLETED	4

Baseline Characteristics

Arm/Group Title	Carboplatin AUC and Abraxane 100mg/m2
Arm/Group Description	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.
Overall Participants	23
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	65
Sex/Gender, Customized (Count of Participants)
Female	23 100%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	4 17.4%
Not Hispanic or Latino	19 82.6%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	2 8.7%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	9 39.1%
White	9 39.1%
More than one race	0 0%
Unknown or Not Reported	3 13%
Region of Enrollment (Count of Participants)
United States	23 100%

Outcome Measures

1. Primary Outcome

Title	Tolerability Measured Completion of Dose Regimen
Description	Tolerability for an individual patient will be defined as remaining on the study for 6 cycles with two or fewer dose reductions.
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Carboplatin AUC and Abraxane 100mg/m2
Arm/Group Description	Carboplatin AUC Abraxane: 100mg/m2
Measure Participants	19
Count of Participants [Participants]	16 69.6%

2. Secondary Outcome

Title	Survival
Description	This will be measured by the Kaplan-Meier curve and progression free survival rates
Time Frame	60 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

3. Secondary Outcome

Title	Percent Progression Free Survival
Description	This will be measured by the Kaplan-Meier curve and progression free survival rates.
Time Frame	60 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Time Frame	24 Months
Arm/Group Title	Carboplatin AUC and Abraxane 100mg/m2
Arm/Group Description	Carboplatin AUC Abraxane: 100mg/m2
All Cause Mortality
	Carboplatin AUC and Abraxane 100mg/m2
	Affected / at Risk (%)	# Events
Total	0/23 (0%)
Serious Adverse Events
	Carboplatin AUC and Abraxane 100mg/m2
	Affected / at Risk (%)	# Events
Total	3/23 (13%)
Blood and lymphatic system disorders
Lymphocyte count decreased	1/23 (4.3%)	1
Gastrointestinal disorders
Small intestinal obstruction	1/23 (4.3%)	1
General disorders
Vomiting	1/23 (4.3%)	1
Dehydration	1/23 (4.3%)	1
Hypoalbuminemia	1/23 (4.3%)	1
Syncope	1/23 (4.3%)	1
Pain	1/23 (4.3%)	1
Myalgia	1/23 (4.3%)	1
Renal and urinary disorders
Acute kidney injury	1/23 (4.3%)	1
Other (Not Including Serious) Adverse Events
	Carboplatin AUC and Abraxane 100mg/m2
	Affected / at Risk (%)	# Events
Total	23/23 (100%)
Blood and lymphatic system disorders
Absolute Neutrophilous Count Decreased	1/23 (4.3%)	1
Alkaline Phosphatase Elevated	1/23 (4.3%)	1
Alkaline Phosphatase Increased	6/23 (26.1%)	6
Alt Increased	3/23 (13%)	3
Anc Decreased	2/23 (8.7%)	2
Anemia	20/23 (87%)	20
Aspartate Aminotransferase Increased	7/23 (30.4%)	7
Ast Increased	3/23 (13%)	3
Blood Bilirubin Increased	1/23 (4.3%)	1
Decreased Anc	2/23 (8.7%)	2
Decreased Neutrolphil Count	3/23 (13%)	3
Decreased Platelet Count	3/23 (13%)	3
Decreased White Blood Cell Count	6/23 (26.1%)	6
Elevated Alkaline Phosphatase	1/23 (4.3%)	1
Elevated Alt	2/23 (8.7%)	2
Elevated Creatinine	1/23 (4.3%)	1
Elevated Potassium	2/23 (8.7%)	2
Cardiac disorders
B/L Deep Vein Thrombosis	1/23 (4.3%)	1
Congenital, familial and genetic disorders
Alopecia	16/23 (69.6%)	16
Eye disorders
Eye Disorders	1/23 (4.3%)	1
Gastrointestinal disorders
Abdominal Pain	4/23 (17.4%)	4
General disorders
Allergic Reaction	1/23 (4.3%)	1
Body Aches(Myalgias)	1/23 (4.3%)	1
Chest Pain	1/23 (4.3%)	1
Constipation	11/23 (47.8%)	11
Cough	1/23 (4.3%)	1
Cough/Clear Sputum	1/23 (4.3%)	1
Decreased Sodium	1/23 (4.3%)	1
Dehydration	4/23 (17.4%)	4
Diarrhea	10/23 (43.5%)	10
Dizziness	4/23 (17.4%)	4
Dry Skin	1/23 (4.3%)	1
Dyseusia	1/23 (4.3%)	1
Dysgeusia	3/23 (13%)	3
Dyspepsia	1/23 (4.3%)	1
Dyspnea	2/23 (8.7%)	2
Ear Infection	0/23 (0%)	0
Edema Limbs	2/23 (8.7%)	2
Epistaxis	1/23 (4.3%)	1
Facial Flushing	1/23 (4.3%)	1
Fall	1/23 (4.3%)	1
Fatigue	16/23 (69.6%)	16
Flu Like Symptoms	1/23 (4.3%)	1
Gastroesophageal Reflux Disease 22	1/23 (4.3%)	1
Generalized Weakness	1/23 (4.3%)	1
Gi Distress/Abdominal	1/23 (4.3%)	1
Gingival Pain	1/23 (4.3%)	1
Gum Infection	1/23 (4.3%)	1
Headache	2/23 (8.7%)	2
Hot Flashes	1/23 (4.3%)	1
Hypercalcemia	1/23 (4.3%)	1
Hyperkalemia	1/23 (4.3%)	1
Hypernatremia	4/23 (17.4%)	4
Hypertension	1/23 (4.3%)	1
Hypoalbuminemia	1/23 (4.3%)	1
Hypocalcemia	1/23 (4.3%)	1
Hypokalemia	7/23 (30.4%)	7
Hypomagnesemia	2/23 (8.7%)	2
Increased Alkaline Phospatase Level	1/23 (4.3%)	1
Increased Alkaline Phosphatase	1/23 (4.3%)	1
Injection Site Reaction	1/23 (4.3%)	1
Insomnia	2/23 (8.7%)	2
Intermittent Abdominal Pain	1/23 (4.3%)	1
Intermittent Anorexia	1/23 (4.3%)	1
Intermittent Blurred Vision	1/23 (4.3%)	1
Intermittent Decreased Platelets	1/23 (4.3%)	1
Intermittent Diarrhea	1/23 (4.3%)	1
Intermittent Dysgeusia	1/23 (4.3%)	1
Intermittent Fatigue	2/23 (8.7%)	2
Intermittent Hyperglycemia	1/23 (4.3%)	1
Intermittent Myalgias	1/23 (4.3%)	1
Intermittent Nausea	7/23 (30.4%)	7
L E Edema	1/23 (4.3%)	1
Le Edema	1/23 (4.3%)	1
Left Arm Pain	1/23 (4.3%)	1
Left Quadrant Pain	1/23 (4.3%)	1
Left-Hand Neuropathy	1/23 (4.3%)	1
Leukocytosis	1/23 (4.3%)	1
Leukopenia	1/23 (4.3%)	1
Low White Blood Cell Count	1/23 (4.3%)	1
Lymphocyte Count Decreased	4/23 (17.4%)	4
Memory Impairment	1/23 (4.3%)	1
Menorrhagia	1/23 (4.3%)	1
Mucositis Oral	1/23 (4.3%)	1
Muscle Weakness Upper Limb	1/23 (4.3%)	1
Musculoskeletal And Connective Tissue Disorder	0/23 (0%)	0
Musculoskeletal Pain	1/23 (4.3%)	1
Myalgia	4/23 (17.4%)	4
Nail Discoloration	2/23 (8.7%)	2
Nail Infection	1/23 (4.3%)	1
Nail Loss	1/23 (4.3%)	1
Nasal Congestion	1/23 (4.3%)	1
Nausea	12/23 (52.2%)	12
Neck Pain	1/23 (4.3%)	1
Neuotrophil Count Decreased	1/23 (4.3%)	1
Neuropathy	1/23 (4.3%)	1
Neutropenia	1/23 (4.3%)	1
Neutrophil Count Decreased	8/23 (34.8%)	8
Pain	4/23 (17.4%)	4
Pain (Tooth)	1/23 (4.3%)	1
Pain In Extremity	1/23 (4.3%)	1
Palpitations	1/23 (4.3%)	1
Paresthesia	5/23 (21.7%)	5
Pelvic Pain	5/23 (21.7%)	5
Peridontal Disease	1/23 (4.3%)	1
Peripheral Neuropathy	2/23 (8.7%)	2
Peripheral Sensory Neuropathy	2/23 (8.7%)	2
Photosensitivity	1/23 (4.3%)	1
Platelet Count	1/23 (4.3%)	1
Platelets Decresed	3/23 (13%)	3
Poor Venous Access	0/23 (0%)	0
Pruritis	1/23 (4.3%)	1
Rash Acneiform	1/23 (4.3%)	1
Right Leg Pain	1/23 (4.3%)	1
Scalp Rash	1/23 (4.3%)	1
Shortness Of Breath	2/23 (8.7%)	2
Skin And Subcutaneous Tissue Disorders	1/23 (4.3%)	1
Syncope	1/23 (4.3%)	1
Tachycardia	2/23 (8.7%)	2
Thrombocytopenia	3/23 (13%)	3
Thromboembolic Event	2/23 (8.7%)	2
Toothache	1/23 (4.3%)	1
Urinary Frequency	2/23 (8.7%)	2
Urinary Urgency	2/23 (8.7%)	2
Vomiting	3/23 (13%)	3
Wbc Decreased	1/23 (4.3%)	1
Weight Loss	1/23 (4.3%)	1
White Blood Cells Decreased	9/23 (39.1%)	9
Wound Complication	1/23 (4.3%)	23
Right Leg Swelling	1/23 (4.3%)	1
Hepatobiliary disorders
Creatinine Increased	4/23 (17.4%)	4
Infections and infestations
Small Intestinal Obstruction	1/23 (4.3%)	1
Injury, poisoning and procedural complications
Back Pain	1/23 (4.3%)	1
Metabolism and nutrition disorders
Colitis	1/23 (4.3%)	1
Psychiatric disorders
Anorexia	11/23 (47.8%)	11
Anxiety	3/23 (13%)	3
Arthralgia	3/23 (13%)	3
Renal and urinary disorders
Acute Kidney Injury	1/23 (4.3%)	1
Alanine Aminotransferase Increased	5/23 (21.7%)	5
Renal And Urinary Disorders	1/23 (4.3%)	1
Respiratory, thoracic and mediastinal disorders
B/L Pleural Effusion	1/23 (4.3%)	1
Upper Respiratory Infection	5/23 (21.7%)	5
Skin and subcutaneous tissue disorders
Skin Hyperpigmentation	2/23 (8.7%)	2
Skin Infection	1/23 (4.3%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.