Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Carcinoma

Carcinoma, Renal Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Kidney Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

Antineoplastic Agents

All Drugs and Chemicals

Sunitinib

Angiogenesis Inhibitors

Growth Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Sunitinib 50 mg by mouth daily for 28 consecutive days. Nephrectomy will occur approximately 24 hours after the last dose of sunitinib.

50 mg by mouth daily for 28 consecutive days

Nephrectomy will occur approximately 24 hours after the last dose of sunitinib.

Nephrectomy

Eric Jonasch, MD

The goal of this clinical research study is to learn if Sutent® (sunitinib malate), given before surgery, can help control renal cell carcinoma. The safety of sunitinib malate will also be studied.

The Study Drug:

Sunitinib malate is designed to block pathways that control important events such as the growth of blood vessels that are essential for the growth of cancer.

Study Treatment:

If you are found to be eligible to take part in this study, you will take sunitinib malate once a day (either with or without food) for 4 weeks in a row, followed by 2 weeks of rest with no study drug. These 6 weeks are considered 1 cycle of study treatment.

During Cycle 2, you will have surgery to remove the tumor. You will start taking sunitinib malate again after surgery (at least 14 days after surgery) on the same schedule as before.

Study Visits:

At the beginning of each new cycle (Cycles 1-6), you will have the following tests:

* Your complete medical history will be recorded.
* You will have a physical exam, including measurement of your vital signs, and weight.
* You will have a performance status evaluation.
* You will be asked about any medicines you are currently taking and if you have experienced any side effects since your last visit.
* You will have blood drawn (about 4 teaspoons) for routine testing. This blood will also be tested to check the function of your thyroid gland.
* You will have follow-up scans (the same ones you had during screening to check the disease status) at the beginning of Cycle 2, after you have surgery, and at the beginning of each of the next 4 cycles.
* You will have an ECG to measure the health of your heart.

Every 2 Cycles, you will have a follow-up echocardiogram or MUGA scan to check your heart function, if your doctor feels it is needed.

Beginning in Cycle 7, you will be asked to return to the clinic every other cycle (about every 12 weeks), unless your doctor thinks you should return more often. This means you would return for clinic visits at the start of Cycles 8, 10, 12, and so on, and may be asked to come back at other times.

At each visit, you will have the following tests:

* Your complete medical history will be recorded.
* You will have a physical exam, including measurement of your vital signs and weight.
* You will have a performance status evaluation.
* You will be asked about any medicines you are currently taking and if you have experienced any side effects since your last visit.
* You will have blood drawn (about 4 teaspoons) for routine testing at the beginning of each cycle. If you are scheduled to return to M. D. Anderson every 2 cycles (12 weeks), you may have the blood drawn for routine tests at your local doctor's office during the "non-visit" cycles.
* You will have an ECG to measure the health of your heart.
* You will have an echocardiogram or MUGA scan to check your heart function, if your doctor feels it is needed.
* You will have follow-up scans (the same ones you had during screening to check the disease status).

Length of Study:

You will continue taking sunitinib malate on this study, unless the disease gets worse, you experience intolerable side effects, and/or you need an alternative treatment during the course of the study.

Early Withdrawal:

Early withdrawal is defined as a patient not being able to complete a full cycle of sunitinib malate. If you withdraw early, you will return to clinic for the following tests:

* Your complete medical history will be recorded.
* You will have a physical exam, including measurement of your vital signs, and weight.
* You will have a performance status evaluation.
* You will have blood drawn (about 4 teaspoons) and urine collected for routine testing. This blood will also be tested to check the function of your thyroid gland.
* You will have an ECG to measure the health of your heart.
* You will be asked about any medicines you are currently taking and if you have experienced any side effects since your last visit.
* You will have follow-up scans (the same ones you had during screening to check the disease status).

Post Treatment Evaluation (within 1 month of the last dose):

About 30 days after your last dose of sunitinib malate, you will return to the clinic for a follow-up visit. You will have the following tests:

* Your complete medical history will be recorded.
* You will have a physical exam, including measurement of your vital signs, and weight.
* You will have a performance status evaluation.
* You will have blood drawn (about 4 teaspoons) and urine collected for routine testing. This blood will also be tested to check the function of your thyroid gland.
* You will be asked about any medicines you are currently taking and if you have experienced any side effects since your last visit.
* You will have follow-up scans (the same as at screening) to check the status of the disease.
* You will have an ECG to measure the health of your heart.

Long-Term Follow-Up:

Following the post-treatment visit, you will be contacted regularly to check the status of the disease. You will be contacted (by telephone or routine clinic visit) every 6-12 weeks for the first 2 years, and every 6 months after that for up to 5 years.

This is an investigational study. Sunitinib malate is commercially available and FDA approved for treatment of clear-cell renal cell carcinoma. At this time, its use in combination with surgery is for research only. Up to 50 patients will take part in this study. All will be enrolled at MD Anderson.

Pre-Surgical Sutent in Renal Cell Carcinoma (RCC)

Phase II Non-Randomized Pre-Surgical Study Evaluating Sunitinib in Patients With Metastatic Renal Cell Carcinoma (RCC) Who Are Eligible for Cytoreductive Nephrectomy

TTP is defined as the time interval between treatment starts and disease progression or death, whichever occurred first, assessed each cycle (42 days).

Toxicity defined as any Grade 3 or greater perioperative complications attributable to sunitinib.

Pfizer

M.D. Anderson Cancer Center

Symptoms and General Pathology

Nervous System Diseases

Recurrence

Brain Neoplasms

Ependymoma

Glioma, Subependymal

Glioma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

Embryonal Tumor With Multilayered Rosettes

Subependymoma

Neuroepithelioma

Amino Acids

Bevacizumab

Antibodies

Antibodies, Monoclonal

Immunoglobulins

Lapatinib

Antineoplastic Agents, Immunological

Tyrosine Kinase Inhibitors

Tyrosine

Bevacizumab 10 mg/kg given by vein over 90 minutes for first injection (30-60 minutes for subsequent doses) every 2 weeks while on study (2 times during each 4-week "study cycle"). Lapatinib Pills of 700 mg/m\^2/dose given orally 2 times each day.

10 mg/kg given by vein over 90 minutes for first injection (30-60 minutes for subsequent doses) every 2 weeks while on study (2 times during each 4-week "study cycle").

Pills of 700 mg/m\^2/dose given orally 2 times each day.

Michael E. Rytting, MD

The goal of this clinical research study is to learn if the combination of Avastin (bevacizumab) and Tykerb (lapatinib) can help to control ependymoma in pediatric patients. The safety of this drug combination will also be studied.

The Study Drugs:

Bevacizumab is designed to block the growth of blood vessels that supply nutrients necessary for tumor growth. This may prevent and/or slow down the growth of cancer cells.

Lapatinib is designed to prevent or slow down the growth of cancer cells by blocking proteins inside the cancer cells.

Study Drug Administration:

If you are found to be eligible to take part in this study, you will receive bevacizumab every 2 weeks while you are on study (2 times during each 4-week "study cycle"). The first time you receive the drug, it will be given by vein over 90 minutes. If this dose is well tolerated, you may receive future doses over 30 minutes.

You will take pills of lapatinib 2 times each day while you are on study. The pills should be taken at about the same time each day. You should not eat or drink anything except water for 1 hour before or 1 hour after you take the pills. If you miss a dose, do not take extra pills the next day to try and make up for the missed dose. You should report any missed pills or any trouble you may have with taking the pills to your study doctor.

You will be given a patient diary in which you must record what time you take lapatinib each time.

Study Visits:

At all study visits, you will be asked about any other drugs that you may be taking and about any side effects that you may be experiencing.

During Cycle 1 the following tests and procedures will be performed at least 1 time each week:

* You will have a physical exam, including measurement of your vital signs.
* Your performance status will be recorded.

Two (2) times each week during Cycle 1, blood (about 2-3 teaspoons) will be drawn for routine tests.

At the end of Cycle 1, urine will be collected for routine tests.

On Days 1 and 15 of Cycle 2, the following tests and procedures will be performed:

* You will have a physical exam, including measurement of your vital signs.
* Your performance status will be recorded.
* Blood (about 2-3 teaspoons) will be drawn for routine tests.

At the end of Cycle 2, you will have an MRI scan of your head to check the status of the disease. If your doctor thinks it is needed, you will also have an MRI of your spine and a spinal tap to check your cerebrospinal fluid (CSF) for presence of disease.

On Day 1 of Cycle 3 and beyond, the following tests and procedures will be performed:

* You will have a physical exam, including measurement of your vital signs.
* Your performance status will be recorded.
* Blood (about 2-3 teaspoons) and urine will be collected for routine tests.

Every 8 weeks, starting with the end of Cycle 4, while you are on study, the following tests and procedures will be performed:

* You will have an MRI scan of the brain to check the status of the disease.
* If your doctor thinks it is needed, you will have an MRI scan of the spine to check the status of the disease.
* If your doctor thinks it is needed, you will have a spinal tap to check your CSF for the presence of disease.

Every 12 weeks while you are on study, the following tests and procedures will be performed to check for possible side effects:

* You will have an echocardiogram or a multiple gated acquisition scan (MUGA) (if the study doctor thinks it is necessary) to test your heart function.
* You will have an x-ray of your right knee.
* If your doctor thinks it is needed, you will have an MRI scan of both knees.

Length of Study:

You will be on study for up to 2 years. You will be taken off study if the disease gets worse, if you experience intolerable side effects, or if the doctor thinks it is in your best interest.

End-of-Treatment Visit:

After you have finished receiving the study drugs, the following tests and procedures will be performed:

* You will have a physical exam, including measurement of your vital signs.
* You will be asked about any other drugs that you may be taking and about any side effects that you may be experiencing.
* Your performance status will be recorded.
* Blood (about 2-3 teaspoons) will be collected for routine tests.
* You will have an echocardiogram or a MUGA scan (if the study doctor thinks it is necessary) to test your heart function.
* You will have an x-ray of your right knee.
* You will have MRI scans of the brain and spine to check the status of the disease.
* If your doctor thinks it is needed, you will have a spinal tap to check the status of the disease.

Long-Term Follow-up:

You will have a follow-up visit 30 days after you have finished receiving the study drugs. The following tests and procedures will be performed:

* You will have a physical exam, including measurement of your vital signs.
* You will be asked about any other drugs that you may be taking and about any side effects that you may be experiencing.
* Your performance status will be recorded.
* Blood (about 2-3 teaspoons) will be collected for routine tests.

This is an investigational study. Bevacizumab is FDA approved and commercially available for the treatment of colon, rectum, lung and certain types of breast cancer. Lapatinib is FDA approved and commercially available for the treatment of certain types of breast cancer. The use of this drug combination in ependymomas in pediatric patients is investigational.

Up to 40 patients will take part in this multicenter study. Up to 6 patients will be enrolled at MD Anderson.

Bevacizumab and Lapatinib in Children With Recurrent or Refractory Ependymoma

A Phase II Study of Bevacizumab and Lapatinib in Children With Recurrent or Refractory Ependymoma

Objective response rate defined as number of participants out of total participants with complete response plus partial response (CR+PR) sustained for at least four weeks. Complete Response (CR) - Complete disappearance on magnetic resonance imaging (MRI) of all enhancing tumor and mass effect, on a stable or decreasing dose of corticosteroids (or receiving only adrenal replacement doses), accompanied by a stable or improving neurologic examination and must be sustained for at least 4 weeks. If cerebrospinal fluid (CSF) for presence of disease was positive it must become negative. Partial Response (PR) - Greater than or equal to 50% reduction in tumor size by bi-dimensional measurement on a stable or decreasing dose of corticosteroids, accompanied by stable or improving neurological examination and must be sustained for at least 4 weeks.

CERN Foundation - Collaborative Ependymoma Research Network

Bevacizumab 10 mg/kg intravenous over 90 minutes for first injection (30-60 minutes for subsequent doses) every 2 weeks while on study (2 times during each 4-week "study cycle"). Lapatinib 700 mg/m\^2/dose given orally 2 times each day.

Bevacizumab + Lapatinib

Age, Categorical

Sex: Female, Male

United States

Region of Enrollment

MD Anderson Multicenter coordinating for Collaborative Ependymoma Research Network Study (CERN)

Of the total, 22 participants were eligible and only 20 evaluable for response.

Objective Response Rate

Overall Study

Gland and Hormone Related Diseases

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Genital Neoplasms, Female

Endocrine System Diseases

Gonadal Disorders

Ovarian Cancer

Ovarian Epithelial Cancer

Gemcitabine

Imatinib Mesylate

Antimetabolites

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, Continuous

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.

Disease Progression

Vasoconstrictor Agents

Respiratory System Agents

Hematinics

Epinephrine

Liver Extracts

Racepinephrine

Epinephryl borate

Stereotactic radiotherapy will be administered for up to five areas of metastatic sites showing oligo-progression within the same time period. During the Sunitinib break period, stereotactic radiotherapy will be delivered in a single fraction or up to a maximum of eight fractions. The number of fractions will depend on how many sites are being irradiated.

SRT to all areas of oligo-progression as follows: BRAIN: 20-24 Gy in 1 fraction if \< 2 cm,18 Gy in 1 fraction if 2-3 cm,15 Gy in 1 fraction for 3-4 cm, alternatively 25-30 Gy in 5 fractions can be used; SPINE: 18-24 Gy in 1-2 fractions,24 Gy in 3 fractions or 30-40 Gy in 5 fractions; NON-SPINE BONE: 30-40 Gy in 5 fractions; LUNG: 48-60 Gy in 4 fractions or 54-60 Gy in 3 fractions for peripheral lung tumours,50 Gy in 5 fractions or 60 Gy in 8 fractions for central lung tumours; LIVER: 30-60 Gy in 3-6 fractions,higher doses for central liver lesions and lower doses for peripheral liver lesions depending on proximity to adjacent organ (stomach, small bowel, large bowel or kidney); ADRENAL OR KIDNEY TUMOURS: 30-40 Gy in 5 fractions; LYMPHADENOPATHY: 30-40 Gy in 5 fractions.

Stereotactic radiotherapy

Georg A. Bjarnason, MD, FRCPC

Patrick Cheung, MD, FRCPC

Stereotactic radiotherapy (SRT) is a newer type of focused radiation therapy that precisely and accurately delivers high dose radiation to a tumour, while sparing much of the nearby normal organs. The use of stereotactic radiotherapy results in high rates of tumour destruction with minimal side effects which are very well tolerated. Often stereotactic radiotherapy has been used to try to cure patients who have an early stage cancer which has not spread, but there is less experience with using it in patients with cancer which has spread.

The purpose of this study is to measure how well stereotactic radiotherapy can destroy kidney cancer tumours which are no longer being controlled by Sunitinib and to measure how much longer such an approach will allow patients to stay on Sunitinib before needing to switch to another medication. Stereotactic radiotherapy will be used to treat only the growing tumours and then patients will continue with Sunitinib.

A Phase II study, single arm study, open-label, safety and efficacy study

Stereotactic Radiotherapy for Metastatic Kidney Cancer Being Treated With Sunitinib

A Phase II, Multi-Centre Study, of Stereotactic Radiotherapy for Oligo-Progression in Metastatic Renal Cell Cancer Patients Receiving 1st Line Sunitinib Therapy

Patients will have evidence of measurable metastatic kidney cancer according to RECIST 1.1 criteria. All progressing metastases sites will be amenable to stereotactic radiotherapy. The primary endpoint of local control will be defined as the absence of local failure in the irradiated site(s). Progressive enlargement will be defined as a 20% enlargement observed on two consecutive scans from baseline scan.

Progression free survival will be evaluated via disease assessments of radiology scans completed every three months from the time of stereotactic radiotherapy until progression is confirmed. Progressive disease will be defined as a 20% increase in RECIST 1.1 criteria measurements observed on two consecutive scans from the baseline scan.

Acute and late toxicities to stereotactic radiotherapy will be assessed from adverse events, vital signs and by clinically significant changes in laboratory evaluations. Adverse events will use the descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. These events will be followed until resolution or for a maximum of two years, which ever occurs first.

Sunnybrook Health Sciences Centre

Antirheumatic Agents

Dermatologic Agents

Reproductive Control Agents

Fludarabine

Fludarabine phosphate

Methotrexate

Melphalan

Tacrolimus

NST using MUD for metastatic renal cell carcinoma

Preparative regimen:

Fludarabine 25 mg/m2 IV once a day x 5 days (-6,-5,-4,-3,-2) Melphalan 70 mg/m2 IV once a day x 2 days (-3,-2) Donor Stem Cell Infusion: Stem cells will be infused on day 0 GVHD prophylaxis: Tacrolimus and methotrexate 5 mg/m2 IV day 1, 3, 6 and 11

Naoto Ueno, M.D., Ph.D.

The purpose of this study is to find out what effects (good and bad) a stem cell transplant from an unrelated donor will have for patients with kidney cancer that has spread to other parts of the body (metastasized).

Standard treatment for kidney cancer that has spread to other parts of the body may include immunotherapy (a therapy that uses the body's natural immune system to fight cancer) and cytokines (proteins found in the body). If these treatments are not successful at controlling the cancer then chemotherapy or thalidomide are used. Chemotherapy and thalidomide will not cure kidney cancer but they may control the disease in some patients.

In some patients, transplants are now proposed for study. Stem cells (from bone marrow or the bloodstream) are normally used to treat cancers of the blood, not kidney cancer. Since researchers are still learning about using stem cell transplants for kidney cancer, the study is considered a research study. Patients participating in this study will receive smaller doses of chemotherapy drugs to prepare them for the transplant than patients who have a standard transplant. This type of transplant is called a "reduced intensity" transplant. A reduced intensity transplant uses the cell-killing activity of the transplanted donor stem cells to attack the recipient's cancer cells. This is called graft-versus-tumor-effect (GVT). Previous studies have shown that GVT may be greater if the donor is not related to the recipient.

Matched Unrelated Donor Transplant for Metastatic Renal Cell Carcinoma

Multicenter Phase II Study of Non-Myeloablative Allogeneic Stem Cell Transplantation Using Matched Unrelated Donor for Metastatic Renal Cell Carcinoma

Only 2 subjects enrolled prior to study closure due to slow accrual.

Center for International Blood and Marrow Transplant Research

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Pre-Surgical Sutent in Renal Cell Carcinoma (RCC)	NCT00715442	Renal Cell Carc...	Sunitinib Nephrectomy	-	M.D. Anderson Cancer Center
Bevacizumab and Lapatinib in Children With Recurrent or Refractory Ependymoma	NCT00883688	Brain Cancer Pediatric Cance...	Bevacizumab Lapatinib	- 21 Years	M.D. Anderson 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
Stereotactic Radiotherapy for Metastatic Kidney Cancer Being Treated With Sunitinib	NCT02019576	Clear Cell Meta...	Stereotactic ra...	18 Years -	Sunnybrook Health Sciences Centre
Matched Unrelated Donor Transplant for Metastatic Renal Cell Carcinoma	NCT00318110	Metastatic Rena...	NST using MUD f...	18 Years - 65 Years	Center for International Blood and Marrow Transplant Research
Use of Regorafenib in Recurrent Epithelial Ovarian Cancer	NCT02736305	Ovarian Neoplas...	Regorafenib	21 Years - 99 Years	National Cancer Centre, Singapore
Rapid Sequencing of Approved Therapies in Patients With Metastatic or Unresectable Clear Cell Renal Cell Carcinoma	NCT05188118	Renal Cell Carc...	Cabozantinib Ipilimumab Nivolumab Lenvatinib Everolimus	18 Years - 99 Years	Icahn School of Medicine at Mount Sinai
Low Dose Decitabine + Interferon Alfa-2b in Advanced Renal Cell Carcinoma	NCT00561912	Renal Cell Carc...	Decitabine Interferon Alfa...	18 Years -	M.D. Anderson 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
EPO906 Therapy in Patients With Advanced Kidney Cancer	NCT00035243	Kidney Neoplasm...	epothilone b	18 Years - 85 Years	Novartis
Pre-Surgical Sutent in Renal Cell Carcinoma (RCC)	NCT00715442	Renal Cell Carc...	Sunitinib Nephrectomy	-	M.D. Anderson Cancer Center
A Study of ENMD-2076 in Ovarian Clear Cell Cancers	NCT01914510	Ovarian Clear C...	ENMD-2076	18 Years -	University Health Network, Toronto
EPO906 Therapy in Patients With Advanced Kidney Cancer	NCT00035243	Kidney Neoplasm...	epothilone b	18 Years - 85 Years	Novartis

Spots Global Cancer Trial Database for clear cell

Every month we try and update this database with for clear cell 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.

Spots Global Cancer Trial Database for clear cell

Every month we try and update this database with for clear cell 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.

Every month we try and update this database with for clear cell 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.