Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Uterine Neoplasms

Endometrial Neoplasms

Neoplasms, Glandular and Epithelial

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Neoplasms by Histologic Type

Antineoplastic Agents

All Drugs and Chemicals

Paclitaxel

Albumin-Bound Paclitaxel

Carboplatin

Tubulin Modulators

Antimitotic Agents

Carboplatin AUC

Abraxane

Franco Muggia, MD

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.

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

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

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.

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

NYU Langone Health

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.

Spots Global Cancer Trial Database for A Phase 2 Feasibility Study of Abraxane and Carboplatin in Epithelial Neoplasms of the Uterus

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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