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.

Age, Continuous

Female

Sex/Gender, Customized

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

1-MD Decision

1. Drug toxicity
2. progressive disease

Tolerability Measured Completion of Dose Regimen

Progression-Free Survival (PFS) at Month 24

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

Overall Study

Gland and Hormone Related Diseases

Rare Diseases

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Uterine Cervical Neoplasms

Ovarian Cancer

Ovarian Epithelial Cancer

Mette Brekke, PhD

Follow-up of cancer patients accounts for a substantial part of outpatient activity, and alternative models of care are developing. In some countries, low-risk follow-up is already done in primary care, mainly in breast, and colorectal cancer. In this study the investigators will explore gynecological cancer patients about their expectations regarding their future follow-up plan. Further, the investigators will ask about the experience and satisfaction among patients who have already attended a follow-up programme for 2-3 years. In addition, the investigators will especially focus on the cooperation aspect between primary and secondary care. The investigators hypothesize that follow-up of selected gynecological cancer patients can be done by general practitioners.

After gynaecological cancer patients have completed their treatment, they are followed up at a gynaecological outpatient clinic for a number of years. The aim of such follow-up is to detect recurrence, improve survival and reduce adverse effects of the treatment. The national guide for oncological gynaecology recommends follow-up by a specialist for five years at intervals depending on cancer type. Several review studies on follow-up of endometrial, cervical and ovarian cancer patients show large international variations in follow-up routines. There are only retrospective studies available, and they indicate that most recurrences are discovered within the first three years after completed treatment, and, in most cases, by the women themselves. More intensive surveillance does not appear to affect the time for discovery of recurrence.

A few randomised controlled studies and retrospective cohort studies have been published that focus on follow-up of colon cancer and breast cancer patients by general practitioners versus by hospital specialists. These studies have not shown any significant differences between the groups in terms of detection of recurrence, incidence of serious clinical events connected with recurrence or health-related quality of life.

The investigators therefore plan to perform a study in which both gynaecological cancer patients and their regular general practitioners are asked about their views on patient follow-up after completed treatment. The investigators especially wish to focus on the collaboration aspect.

Follow-up of Gynecological Cancer Patients, Their Needs and Expectations, A Cooperation Project

Gynecological Cancer Survivors' Views on Follow-up After Cancer Treatment

The patients will be asked to fill in a quesionnaire regarding their expectations on follow-up care

The patients will be asked to fill in a quesionnaire regarding their satisfaction on follow-up care after three years

University of Oslo

Symptoms and General Pathology

Recurrence

Adenocarcinoma

Adenocarcinoma, Clear Cell

Disease Attributes

Carcinoma

Pembrolizumab

Lenvatinib

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Recurrent clear cell carcinoma of gynecological origin (ovarian and endometrial primary) after progression on chemotherapy.

All patients will receive oral lenvatinib daily plus intravenous pembrolizumab 3-weekly.

A cycle is 21 days. Allowances will be made for stepwise dose reductions of lenvatinib due to treatment-related toxicities.

Toxicity will be assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events, (CTCAE) Version 5.0.

Patients are planned to continue therapy until disease progression, intolerable toxicity, or withdrawal of patient consent.

pembrolizumab and lenvatinib

David Shao Peng Tan

This is a phase II non-randomized, multi-center study. The primary end point of this study is the objective response rate (ORR) at 24 weeks, using response evaluation criteria for solid tumors (RECIST) 1.1 criteria, for the combination therapy of continuous daily oral lenvatinib with three-weekly intravenous pembrolizumab in patients with recurrent clear cell carcinoma of gynecological origin (CCGC). The statistical design is Simon's minimax two-stage design and the present study aims to complete stage 1 of the Simon's two-stage design.

Primary Objective

(1) Objective: To determine the efficacy as measured by the objective response rate (ORR) at 24 weeks using RECIST 1.1 criteria when patients with recurrent CCGCs are treated with lenvatinib plus pembrolizumab.

Hypothesis: The ORR (complete response plus partial response) at 24 weeks seen in recurrent CCGC patients treated with lenvatinib plus pembrolizumab combination therapy will be improved compared to historical control (hypothesized ORR of 30% with combination therapy compared to historical ORR of ORR of 10% with chemotherapy).

Primary Endpoint: The ORR at 24 weeks using RECIST 1.1 criteria when patients with recurrent CCGCs are treated with lenvatinib plus pembrolizumab.

Secondary Objectives,

1. Objective: To determine the efficacy of lenvatinib plus pembrolizumab in recurrent CCGCs.

   Hypothesis: The ORR by immune RECIST (iRECIST) criteria, progression-free survival (PFS) rate and clinical benefit rate (CBR) (complete response plus partial response plus stable disease) at 24 weeks, as well as duration of response and PFS observed in recurrent CCGC patients treated with lenvatinib plus pembrolizumab combination therapy will be improved compared to historical control.

   Endpoint: To determine the ORR using iRECIST criteria at 24 weeks when patients with recurrent CCGCs are treated with lenvatinib plus pembrolizumab.

   Endpoint: To assess the duration of response when patients with recurrent CCGCs are treated with lenvatinib plus pembrolizumab.

   Endpoint: To assess the PFS when patients with recurrent CCGCs are treated with lenvatinib plus pembrolizumab.

   Endpoint: To determine the 24 week PFS rate of lenvatinib plus pembrolizumab in this population.

   Endpoint: To determine the CBR at 24 weeks of lenvatinib plus pembrolizumab in this population.
2. Objective: To describe the adverse event (AE) profile of lenvatinib plus pembrolizumab in this patient population.

Exploratory Objectives

1. Clinical Objectives: To evaluate the effect of potential prognostic factors (baseline patient and tumor characteristics, notably: initial performance status, stage at diagnosis and platinum-free interval), on the efficacy of lenvatinib plus pembrolizumab in this population.
2. Translational Objectives: To evaluate the pre- to post-treatment changes in the frequency of tumor-associated macrophages (TAMs) in patients receiving lenvatinib plus pembrolizumab.
3. Translational Objectives: To evaluate the pre- to post-treatment changes in the frequency and gene expression profile of different lymphocyte (e.g. CD4, CD8, Treg, B cells) and myeloid (e.g. DCs, MDSCs) subsets in patients receiving lenvatinib plus pembrolizumab.
4. Translational Objectives: To identify predictive biomarkers of response in patients receiving lenvatinib plus pembrolizumab (e.g. PD-1/PD-L1/VEGF expression).
5. Translational Objectives: To evaluate the pre-to post-treatment changes in the concentration of relevant cytokines/chemokines (e.g.: GM-CSF, G-CSF, VEGFA, IL2, IL12, IL13, IL6, Interferons) in patients receiving lenvatinib plus pembrolizumab.

combination therapy of continuous daily oral lenvatinib with three-weekly intravenous pembrolizumab in patients with recurrent clear cell carcinoma of gynecological origin (CCGC).

Trial of Lenvatinib Plus PembrolizumAb in Recurrent Gynecological Clear Cell Adenocarcinomas (LARA)

Phase II Trial of Lenvatinib Plus PembrolizumAb in Recurrent Gynecological Clear Cell Adenocarcinomas (LARA)

the percentage of subjects with a confirmed CR or PR as per RECIST 1.1 criteria.

time from enrolment to the first documented tumor progression, or death due to any cause whichever occurred first. PFS time of any living patient with no documented progression, or any patient starting other cytotoxic and/or cytostatic therapies, will be censored at the date of last evaluable disease assessment on-study. PFS time of patients with no evaluable disease assessment on-study will be censored at enrollment

This will be measured from the time measurement criteria for CR/PR (whichever is first recorded) are first met until the first date that recurrent or progressive disease is objectively documented.

National University Hospital, Singapore

Fallopian Tube Neoplasms

Adnexal Diseases

Fallopian Tube Diseases

Fallopian Tube Cancer

Gastrointestinal Agents

Alvimopan

Perioperative administration of oral alvimopan, 12mg twice daily, starting with 1 dose preoperative. Drug was continued for duration of hospital stay, but did not exceed 7 days.

Perioperative administration of placebo, at same dosing interval as study drug.

Perioperative administration of oral alvimopan, 12mg twice daily, starting with 1 dose preoperative.

Placebo

Jamie Bakkum-Gamez, MD

This study is designed to determine whether an oral perioperative medication (alvimopan--a selective mu antagonist) improves bowel recovery over placebo after surgery for ovarian cancer.

Accelerating Gastrointestinal Recovery

Accelerating Gastrointestinal Recovery in Women Undergoing Staging and/or Debulking Surgery for Epithelial Ovarian, Fallopian Tube, and Primary Peritoneal Carcinoma: A Randomized, Double-Blind, Placebo-Controlled Trial

Length of stay = date/time of hospital dismissal - date/time of end of surgery

Ileus was defined as MD-diagnosed, return to nothing by mouth (NPO) status, or insertion of nasogastric tube for ileus.

Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Jamie N. Bakkum-Gamez

Consultant and Assistant Professor of Obstetrics-Gynecology,

Perioperative administration of oral placebo, at same dosing interval as study drug, starting with one dose preoperative. Drug was continued for duration of hospital stay, but did not exceed 7 days..

Total

Sex: Female, Male

Primary surgery

Interval debulking

Secondary debulking

Surgery Type

I/II

III/IV

Other non-ovarian primary cancers

Benign pelvic masses

Recurrent disease

Cancer Stage used the Fédération Internationale de Gynécologie et d'Obstétrique (FIGO) staging system. For ovarian cancer, there are 4 stages: stage I: confined to the organ of origin, stage II: invasion of surrounding organs or tissue, stage III: spread to distant nodes or tissue within the pelvis, stage IV: distant metastasis(es)

Cancer Stage

Yes, measurable (</= 1 cm)

Yes, suboptimal (>1 cm, limited sites)

Yes, extensive (multiple sites/organs)

Residual Disease

Baseline characteristics are provided for the subjects who completed study follow up.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Phase 2 Feasibility Study of Abraxane and Carboplatin in Epithelial Neoplasms of the Uterus	NCT02744898	Endometrial Can...	Carboplatin AUC Abraxane	18 Years -	NYU Langone Health
Follow-up of Gynecological Cancer Patients, Their Needs and Expectations, A Cooperation Project	NCT01691144	Endometrial Can... Ovarian Cancer Cervical Cancer		19 Years -	University of Oslo
Trial of Lenvatinib Plus PembrolizumAb in Recurrent Gynecological Clear Cell Adenocarcinomas (LARA)	NCT04699071	Adenocarcinomas Recurrent Gynec...	pembrolizumab a...	21 Years - 99 Years	National University Hospital, Singapore
Accelerating Gastrointestinal Recovery	NCT01704651	Ovarian Cancer Fallopian Tube ... Peritoneal Canc...	Alvimopan Placebo	18 Years -	Mayo Clinic
Follow-up of Gynecological Cancer Patients, Their Needs and Expectations, A Cooperation Project	NCT01691144	Endometrial Can... Ovarian Cancer Cervical Cancer		19 Years -	University of Oslo
Trial of Lenvatinib Plus PembrolizumAb in Recurrent Gynecological Clear Cell Adenocarcinomas (LARA)	NCT04699071	Adenocarcinomas Recurrent Gynec...	pembrolizumab a...	21 Years - 99 Years	National University Hospital, Singapore
A Phase 2 Feasibility Study of Abraxane and Carboplatin in Epithelial Neoplasms of the Uterus	NCT02744898	Endometrial Can...	Carboplatin AUC Abraxane	18 Years -	NYU Langone Health

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