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

NCT02744898 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: 15-01156
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Endometrial Cancer

Keywords

uterus; gynecological; corpus uteri

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Progression-Free Survival (PFS) at Month 24

  Up to Month 24

• Objective Response Rate (ORR) as Measured by RECIST 1.1 at Month 24

  Up to Month 24

Study Arms (1)

Carboplatin AUC and Abraxane 100mg/m2

EXPERIMENTAL

Drug: Carboplatin AUC; Drug: Abraxane

Interventions

Carboplatin AUC DRUG

Carboplatin AUC and Abraxane 100mg/m2

Abraxane DRUG

100mg/m2

Also known as: Paclitaxel

Carboplatin AUC and Abraxane 100mg/m2

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Perlmutter Cancer Center

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Endometrial Neoplasms

Interventions

Albumin-Bound Paclitaxel; Paclitaxel

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Franco Muggia, MD
• Organization: NYU Langone Health

Franco.Muggia@nyulangone.org

212 263 2172

Study Officials

• Franco Muggia, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2016
• First Posted: April 20, 2016
• Study Start: July 1, 2016
• Primary Completion: August 17, 2018
• Study Completion: March 1, 2020
• Last Updated: September 26, 2023
• Results First Posted: March 18, 2020

Record last verified: 2023-08

Locations

US (1)