Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

All Conditions

Rare Diseases

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Carcinoma

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Ovarian Cancer

Ovarian Epithelial Cancer

Antineoplastic Agents

All Drugs and Chemicals

Amino Acids

Gemcitabine

Imatinib Mesylate

Antimetabolites

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

All research subjects receive oral imatinib 400mg days 1-5 and 8-12 of a 21 day cycle.

All research subjects received IV gemcitabine 1000mg/m2 days 3 and 10 of a 21-day cycle. .

All subjects had epithelial ovarian cancer or primary peritoneal carcinomatosis and had failed to respond to prior chemotherapy or progressed after prior chemotherapy.

imatinib mesylate - 400mg orally, daily on Days 1-5 and 8-12 of a 21 day cycle.

imatinib mesylate by mouth

Gemcitabine - 1000 mg/m2 IV on Day 3 and Day 10 of a 21 day cycle

Gemcitabine Intravenous

David McCune, MD, MPH

This study will evaluate the efficacy and tolerability of the combination of Gleevec and Gemzar in patients with ovarian cancer, who have progressed after receiving at least one prior chemotherapy treatment. Gleevec is an oral chemotherapy drug used is this study and Gemzar is an IV chemotherapy drug used. Participation in the treatment portion of the study will continue as long as the patient's tumors shrink or remain stable and as long as the patient is able to tolerate the study drug. The follow-up portion of the study will last for 5 years.

Each 21 day period will be considered a cycle. Disease status will be assessed with a Cancer Antigen (CA)-125 prior to the start of each new cycle with an assessment of measurable diseased by either CT or MRI every 6 weeks. Treatment will continue until disease progression, unacceptable toxicities, or the patient elects to withdraw from the study. All patients will be followed until disease progression or study withdraw. In addition, following disease progression, patients will be monitored for delayed toxicity and survival for a period of 5 years, unless consent is withdrawn.

Gleevec and Gemzar in Patients With Epithelial Ovarian Cancer

A Phase II Trial of Gleevec and Gemzar in Patients With Epithelial Ovarian Cancer Who Have Failed at Least Two Prior Therapies

Progression free survival at six months was assessed for all research subjects. Progression defined by SWOG criteria: Invest New Drugs. 1992 Nov;10(4):239-53. Progression is defined as \> 50% increase in the sume of measured cross sectional area of areasa of measurable disease, measured from the lowest measured amount of disease. Progression is also defined as new areas of measurabe disease.

Toxicity was assess prior to each cycle of therapy (every 3 weeks) and graded based on NCI common toxicity criteria

Best response to thearpy was assessed using modified SWOG criteria (same as for outcome masure #1). Subjects were assess as "complete response", "partial response", "stable disease", and "progressive disease" after 2 cycles (6 weeks) of beginning treatment and every 6 weeks afterward until progression of disease, unacceptable toxicity, or subject withdrawl from study.

the measurement reported is the number of patients who met the criteria for partial response.

All subjects were followed after treatment was complete to assess overall survival.

Using SWOG criteria for response of measurable disease, subject best response was assessed. First assessment was 6 weeks after starting treatment. Subjequent evaluations were every 6 weeks in patients who remained on study.

Repsonse rate was the sum of Complete Repsonse and Partial Response.

The study was stopped after 8 subjects. It was not possible to perform meaningful analysis on prognostic variables. this outcome measure was not done.

Novartis

Henry M. Jackson Foundation for the Advancement of Military Medicine

Principal Investigator

Adverse events were scored based on NCI common toxicity criteria. All serious adverse events and all non-serious adverse events were reported.

Open label, non-randomized, single treatment group.

Treatment

Age, Categorical

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

This study was terminated due to a combination of poor accrual and lack of evidence of benefit.

COL David E. McCune, MD, MC

Open label, non-randomized, single treatment group.

All subjects has measurable or evaluabel epithelial ovarian cancer or preitoneal carcinomatosis. all subjects were treated with oral imatinib and IV gemcitabine.

Oral Imatinib Plus Gemcitabine

of 8 enrolled subjects, 7 were eligible for analysis of progression-free survival at 8 months. One subject declined to continue treatment

The Cystostatic, Anti-tumor Activity of the Combination of Gleevec and Gemzar Via Progression-free Survival for at Least Six Months in Patients With Recurrent or Persistent Epithelial Ovarian or Primary Peritoneal Carcinoma.

Grade 3 toxicity

Grade 4 toxicity

Red Blood Cell Transfusion

Oral Imatinib Puls IV Gemcitabine

To Determine the Safety and Tolerability Via Frequency and Severity of Adverse Effect of Combination Gleevec and Gemzar in This Cohort of Patients as Assessed Byt Common Toxicity Criteria

Open label, non-randomized, single treatment group. all subjects had epithelial ovarian cancer or primary peritoneal carcinomatosis that progressed after prior treatment.

Oral Imatinib Plus IV Gemcitabine

All subjects who underwent treatment and participated in the study were analysed

Tumor Response Rates Using Modified SWOG Criteria to the Combination of Gleevec and Gemzar in Patients With Relapsed Ovarian Cancer Who Have Failed at Least One Prior Chemotherapy Treatment.

To Determine the Distribution of the Overall Survival

All subjects were assessed after 6 weeks of treatment and reassessed at 6 week intervals

To Estimate the Clinical Response Rate(Partial and Complete Response as Defined Under the SWOG Criterial)

To Assess the Effects of Prognostic Variables; Initial Performance Status; Platinum Sensitivity, and Mucinous (or Clear Cell)Histology on Progression-free Survival Overall.

Overall Study

Symptoms and General Pathology

Recurrence

Patients will receive Regorafenib 120mg once daily, with consideration for dose escalation to 160mg if there are no toxicities

Once a day for 21 days in a 28 days cycle

Regorafenib

Wen Yee Chay, MBBS

Regorafenib is an oral multikinase inhibitor that blocks the activity of kinases involved in angiogenesis (VEGFR 1,2,3 and TEK), oncogenesis (KIT, Ret Proto-Oncogene (RET), Raf-1 Proto-Oncogene, Serine/Threonine Kinase (RAF1) and BRAF) and tumour growth (PDGFR and FGFR). Epithelial ovarian cancer (EOC) cell lines frequently express high levels of vascular endothelial growth factor (VEGF) and in vivo preclinical studies evaluating Regorafenib have shown promising activity in ovarian cancer. In the clinic, anti-angiogenesis therapy with bevacizumab (a monoclonal antibody to VEGF) has already emerged as an important cornerstone in the management of ovarian cancer both as part of frontline adjuvant treatment and as second-line therapy for platinum-sensitive recurrent disease. Whilst Regorafenib has been FDA approved for the treatment of patients with metastatic colorectal cancer who have failed prior bevacizumab, it's role in the management of ovarian cancer remains to be defined.

STUDY OBJECTIVES

The objective of this study is to evaluate the efficacy and safety of regorafenib at a dose of 120mg daily for 21 days out of every 28 day cycle in Asian females with multiply recurrent EOC.

Primary Endpoint:

Investigator assessed progression free survival (PFS)

Secondary Endpoints:

Use of Regorafenib in Recurrent Epithelial Ovarian Cancer

An Open-Label, Single-Arm Phase 2 Clinical Trial Of Regorafenib in Patients With Multiply Recurrent Epithelial Ovarian Cancer

During the study period, patients will undergo evaluations for safety and drug tolerability.

* Unexpected and expected toxicities including Hand Foot Syndrome, Liver dysfunction, Hypertension, Bleeding, Nausea and Diarrhoea
* Death

National Cancer Centre, Singapore

Uterine Neoplasms

Endometrial Neoplasms

Uterine Diseases

Anti-Infective Agents

Everolimus

Sirolimus

Temsirolimus

MTOR Inhibitors

Immunosuppressive Agents

Immunologic Factors

RAD001

Karen H. Lu, MD

The goal of this clinical research study is to learn if RAD001 can shrink or slow the growth of tumors in patients who have recurrent endometrial cancer. The safety of this drug will also be studied.

Objectives:

Primary Objective:

1. To determine the efficacy of RAD001 in patients with progressive or recurrent endometrial cancer.

Secondary Objective:

1. To determine the nature and degree of toxicity of RAD001 in this cohort of patients.
2. To characterize, in pre- and post- treatment tumor samples, when available, expression levels of total and phosphorylated mTOR (mammalian "target of rapamycin") as well as relevant upstream and downstream signaling components (optional).

RAD001 is a new drug that was designed to block proteins that are important in the development and growth of cancer.

Before treatment starts, you will have a complete physical exam, routine blood tests (about 2-3 teaspoons), a chest x-ray, and a CT scan or MRI of the abdomen and pelvis. Women who are able to have children must have a negative blood pregnancy test.

Routine blood tests (about 2 teaspoons) will be done weekly during treatment, and before each course of therapy, which is every 4 weeks. A complete checkup including evaluation of side effects, will also be done before each course of therapy and at the end of therapy (4 weeks after treatment ends).

You will take RAD001 10 mg by mouth every day. One course of therapy is 4 weeks long. RAD001 should be taken the same time every day on an empty stomach (fasting state) or after no more than a light, fat-free meal. You should wait at least 6 hours after a eating a regular (not fat-free meal) before taking RAD001. You should not eat fatty foods for at least one hour after taking RAD001.

If side effects occur at this dose, your doctor may lower the RAD001 dose, depending on the severity of the side effects. After an additional 4 weeks of therapy, if the dose was reduced and the side effects have resolved, your doctor may increase the dose back to the original dose, or you may continue at the reduced dose.

You will only be given the amount of drug needed for one course of therapy at a time. You will keep a diary during the study that will list when and how much drug you took. This diary will be reviewed after each course of therapy by the research nurse or physician and filed in your chart.

You will have CT or MRI scans and chest x-rays (only in patients with chest disease) to evaluate the response of your tumor to treatment. These scans will be done after the first two courses (eight weeks) and every third course (every 12 weeks) and at the end of therapy. Treatment will be stopped if the disease gets worse or intolerable side effects occur.

This is an investigational study. RAD001 has been authorized by the FDA for use in research only. Up to 35 patients will take part in this study. All will be enrolled at M. D. Anderson.

RAD001 in Recurrent Endometrial Cancer Patients

A Phase II Study of RAD001 in Patients With Recurrent Endometrial Cancer

Response determined by tumor assessments from radiological tests or physical examination using Response Evaluation Criteria In Solid Tumors (RECIST). Complete Response (CR): Disappearance of all target and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Partial Response (PR): At least 30% decrease in sum of the longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. Stable Disease (SD): Any condition not meeting the above criteria. The minimum duration for the SD will be 8 weeks. If the participant has stable disease at the time of the first radiographic evaluation, he/she will be considered to have stable disease. Progressive Disease (PD): At least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD or the appearance of new lesions within 8 weeks of study entry.

Clinical benefit rate (CBR) is defined as the objective response rate plus the proportion of participants with prolonged stable disease (SD), e.g. nonprogression at 20 weeks. Objective response rate (ORR), determined by tumor assessments from radiological tests or physical examination using Response Evaluation Criteria In Solid Tumors (RECIST).

M.D. Anderson Cancer Center

Karen H. Lu, MD, Chair, Gynecologic Oncology & Reproductive Medicine

Complete Response (CR)

Partial Response (PD)

Stable Disease (SD)

Progressive Disease (PD)

Of the 35 participants, four (4) were inevaluable due to inadequate treatment on trial.

Number of Participants With Objective Response Plus Stable Disease Rate (CR + PR + SD)

Clinical Benefit Rate

Nutritional and Metabolic Diseases

Obesity

Paclitaxel

Carboplatin

Pembrolizumab

Albumin-Bound Paclitaxel

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Single dose of Pembrolizumab 200mg IV administered prior to hysterectomy and surgical staging.

A single dose of Pembrolizumab (200 mg) will be administered IV over 30 min (-5 /+10 min) approximately 3 weeks prior to the scheduled hysterectomy.

Pembrolizumab (200 mg) will be administered IV over 30 min (-5/+10 min) every three weeks in combination with paclitaxel and carboplatin as adjuvant therapy over 6 cycles. Pembrolizumab should be given on D1 of each cycle after the infusion of cytotoxics.

Hysterectomy/Surgical Staging per institutional standard of care.

Hysterectomy

Victoria Bae-Jump, MD

Programmed cell death 1 (PD-1) inhibitor treatment may benefit patients with endometrial cancer (EC) based on the following observations: 1) an overwhelming presence of PD-1 in ECs; 2) the well-known effect of obesity which activates pro-inflammatory white blood cells and promotes the development of ECs; and 3) the high prevalence of a specific gene pattern (ie, microsatellite instability hypermutated \[MSI high\]) among ECs that may be particularly sensitive to this class of drugs. To identify potential biomarkers of response to PD-1 inhibitors in EC, we will conduct a window of opportunity study of pembrolizumab in 20 patients with clinical stage 1, grade 3 EC, encompassing endometrioid, serous and clear cell histologies. Eligible patients will undergo a research biopsy for collection of fresh tissue at the time of enrollment, in addition to the routinely performed endometrial biopsy that led to the diagnosis of their cancer. Patients will receive a single dose of pembrolizumab (200 mg IV) prior to undergoing their scheduled hysterectomy with surgical staging three weeks later. As per standard of care, adjuvant chemotherapy with paclitaxel and carboplatin will be recommended after hysterectomy/surgical staging for women with endometrioid tumors and stage III disease or women with serous/clear cell tumors at all stages of disease. However, in this study pembrolizumab will be added to adjuvant paclitaxel and carboplatin for EC. Pre-treatment endometrial biopsy specimens (fresh frozen tissue and formalin-fixed paraffin embedded (FFPE)) and a post-treatment hysterectomy specimen (fresh frozen tissue and FFPE) will be collected for translational studies. Blood, fecal and vaginal samples will be collected pre-treatment, at the time of surgery and following 3 cycles of adjuvant pembrolizumab/paclitaxel/carboplatin treatment.

The primary objective of the trial is to measure the change in number and phenotype of tumor-infiltrating lymphocytes, including delineation of effector and regulatory T cells, before and after one cycle of pembrolizumab treatment. Other correlative secondary objectives include investigation of associations among pre-treatment TIL numbers, clonality of TILs and change in number and phenotype of TILs with samples collected after pembrolizumab treatment between MSI and DNA polymerase (POLE) ultramutated ECs versus MSI low/stable ECs versus copy number high (CNH) ECs, among others. To assess the complex interplay between obesity, molecular subtype, the microbiome and immune regulation, gut, vaginal and uterine microbiota profiles will be characterized and potential associations with body mass index (BMI), pre-treatment TIL numbers, clonality of TILs and change in the number and phenotype of TILs will be investigated. Secondary clinical objectives include (1) of the pathologic response rate after one cycle of pembrolizumab following hysterectomy and surgical staging in stage I/II, serous/clear cell EC and stage III, G3 (serous, clear cell or endometrioid histologies) EC and (2) characterization of the toxicity profile of pembrolizumab pre-hysterectomy and in combination with paclitaxel and carboplatin as adjuvant therapy for EC.

Window of Opportunity Pilot Study of Pembrolizumab in Obesity-driven Endometrial Cancer

Change in number of tumor-infiltrating lymphocytes in response to single dose of pembrolizumab will be determined by performing histopathologic analysis of H\&E-stained tumor sections collected at baseline and at the time of surgery.

The NCI Common Terminology Criteria for Adverse Events is a descriptive terminology which can be utilized for Adverse Event (AE) reporting. A grading (severity) scale is provided for each AE term. Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental Activities of Daily Living (ADL). Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL. Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE.

Count and compare associations of (1) pre-treatment Tumor Infiltrating Lymphocyte (TIL) numbers (2) clonality of TILs and (3) change in number and phenotype of TILs with pembrolizumab treatment between Microsatellite Instability (MSI) and DNA Polymerase ε Endometrial Cancers (EC) versus MSI low/stable ECs versus Copy Number High ECs.

Compare possible associations of PD-1, Programmed Death Ligand 1 (PD-L1) and Programmed Death Ligand 2 (PD-L2) messenger Ribonucleic Acid (mRNA) expression with (1) pre-treatment TIL numbers (2) clonality of TILs and (3) change in number and phenotype of TILs.

Compare possible associations of immune and obesity/inflammation EC signatures with (1) Body Mass Index (BMI) (2) pre-treatment TIL numbers (3) clonality of TILs and (4) change in number and phenotype of TILs.

Compare possible associations of gut, vaginal and uterine microbiota profiles with (1) BMI (2) pre-treatment TIL numbers (3) clonality of TILs and (4) change in number and phenotype of TILs.

Calculate the overall response rate of pembrolizumab in combination with paclitaxel and carboplatin following hysterectomy and surgical staging in (1) stage I/II, serous/clear cell EC and (2) stage III, Grade 3 (serous, clear cell or endometrioid histologies) EC.

Response is measured as:

Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis \<10mm.

Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Gleevec and Gemzar in Patients With Epithelial Ovarian Cancer	NCT00928642	Ovarian Cancer Primary Periton...	imatinib mesyla... Gemcitabine Int...	18 Years -	Henry M. Jackson Foundation for the Advancement of Military Medicine
Use of Regorafenib in Recurrent Epithelial Ovarian Cancer	NCT02736305	Ovarian Neoplas...	Regorafenib	21 Years - 99 Years	National Cancer Centre, Singapore
RAD001 in Recurrent Endometrial Cancer Patients	NCT00087685	Endometrial Can...	RAD001	-	M.D. Anderson Cancer Center
Window of Opportunity Pilot Study of Pembrolizumab in Obesity-driven Endometrial Cancer	NCT03694834	Endometrial Can... Uterine Cancer	Pembrolizumab Hysterectomy	18 Years -	UNC Lineberger Comprehensive Cancer Center
Gleevec and Gemzar in Patients With Epithelial Ovarian Cancer	NCT00928642	Ovarian Cancer Primary Periton...	imatinib mesyla... Gemcitabine Int...	18 Years -	Henry M. Jackson Foundation for the Advancement of Military Medicine
Window of Opportunity Pilot Study of Pembrolizumab in Obesity-driven Endometrial Cancer	NCT03694834	Endometrial Can... Uterine Cancer	Pembrolizumab Hysterectomy	18 Years -	UNC Lineberger Comprehensive Cancer Center
RAD001 in Recurrent Endometrial Cancer Patients	NCT00087685	Endometrial Can...	RAD001	-	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for endometrioid

Every month we try and update this database with for endometrioid cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.