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Female Urogenital Diseases and Pregnancy Complications

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Renal Cell Carcinoma

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Antineoplastic Agents

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Anti-Infective Agents

Everolimus

Sunitinib

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Temsirolimus

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Enzyme Inhibitors

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Immunologic Factors

Angiogenesis Inhibitors

Growth Inhibitors

Sunitinib 50 mg by mouth daily for 4 weeks on / 2 weeks off.

50 mg by mouth daily for 4 weeks on / 2 weeks off

Amado Zurita, MD

The goal of this clinical research study is to compare the effectiveness of Afinitor (everolimus) and Sutent (sunitinib) for the treatment of advanced renal cell carcinoma (kidney cancer). The safety of each treatment will also be studied.

The Study Drugs:

Everolimus is designed to stop cells from multiplying. It may also stop the growth of new blood vessels that help tumor growth, which may cause the tumor cells to die.

Sunitinib 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 Groups and Study Drug Administration:

If you are found to be eligible to take part in this study, you will be randomly assigned (as in the toss of a coin) to 1 of 2 groups.

* If you are assigned to Group 1, you will take 2 everolimus tablets by mouth once every day.
* If you are assigned to Group 2, you will take sunitinib capsules by mouth every day for 4 weeks, followed by 2 weeks off.

If you have any side effects from any of the drugs, tell the study doctor right away. The study doctor may then lower the dose or keep the dose level the same.

Every 6 weeks on this study is called a study "cycle."

If the disease gets worse or you have intolerable side effects while you are on study, you will have the chance to receive the study drug that you did not receive at first. The dosing and follow-up will be the same as for all participants in that group.

Study Visits:

On Day 1 of every cycle:

* You will have a physical exam, including measurement of your vital signs.
* You will be asked about any drugs or treatments you may be receiving.
* Your performance status will be recorded.
* Blood (about 3 teaspoons) and urine will be collected for routine tests and a fasting blood sugar test. Blood or urine will also be used for a pregnancy test for women who are able to have children. If you are in Group 1, you will have an additional 1 teaspoon of blood drawn to test your cholesterol.

On Day 15 and 29 of Cycle 1:

* Your vital signs and weight will be measured.
* Blood (about 2 teaspoons) will be drawn for routine tests. If you are in Group 1, an additional 1 teaspoon of blood will be drawn to measure your cholesterol.

The Day 15 and Day 29 tests may be done at your local doctor's office.

On Day 1 of Cycles 2 and 3, and every other cycle after that (Day 1 of Cycle 5, 7, 9 and so on):

°You will have a CT scan of the chest and a CT scan or MRI of the abdomen to check the status of the disease.

Every 4 cycles (24 weeks):

°If you are in Group 2, you will have an echocardiogram or MUGA scan to check your heart's health.

Length of Study:

You may continue taking the study drugs for as long as you are benefiting. You will be taken off study if the disease gets worse or intolerable side effects occur.

End-of-Treatment Visit:

If you have stopped taking the study drug because of intolerable side effects, the treating physician will make every effort to check the status of the disease before you are taken off of study.

Long-Term Follow-up:

Once you are no longer on this study, the research staff will check up on you about every 6 months. This update will consist of a phone call or a review of your medical and/or other records. You will not have any extra tests, procedures, or study visits. If contacted by phone, the call would only last about 5 minutes.

This is an investigational study. Sunitinib and everolimus are both FDA approved and commercially available for the treatment of advanced kidney cancer.

Up to 108 patients will be enrolled in this multicenter trial. Up to 108 patients will be enrolled at MD Anderson.

Everolimus Versus Sunitinib in Non-Clear Cell Renal Cell Carcinoma

Everolimus Versus Sunitinib Therapy in Patients With Advanced Non-clear Cell Renal Cell Carcinoma

The amount of time after the first line medication begins until the cancer gets worse progresses. Progression is measured by an increase in measures tumors of at least 20 %, or overall increase in all the tumors, or the presence of new tumors.

The amount of time after the crossover medication begins until the cancer gets worse progresses. Progression is measured by an increase in measures tumors of at least 20 %, or overall increase in all the tumors, or the presence of new tumors.

Side effects, also called adverse events, that were related to either drug were documented and graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3. Grades increases in severity from 1 - 5. Grade one is a mild change which only requires monitoring. Grade 2 is a moderate change and may require some medication. Grade 3 is severe and requires hospitalization. Grade 4 is life threatening. Grade 5 is death.

The amount of time each participant is alive from the start of the first line therapy.

The best overall response for each participant was determined by using the Response Evaluation Criteria for Solid Tumors (RECIST). The responses are Complete Response (CR), Partial Response (PR), Stable Disease (SD), and Progression Disease (PD). CR is the disappearance of the cancer everywhere in the participant. PR is at least a 30 % reduction in the measured tumors from baseline. SD is no discernible change in the presence of cancer. Progressive disease is an increase of at least 20% of the measured cancer from the cancer's smallest measure.

Novartis

M.D. Anderson Cancer Center

Adverse events that were related to either medication were documented and graded for severity according to the Common Terminology Criteria of Adverse Events (CTCAE) version 3. Grades increase in severity from 1 - 5. Grade 1 is a mild change. Grade 2 is a moderate change. Grade 3 is a sever change and may require hospitalization. Grade 4 is life threatening. Grade 5 is death.

4 weeks of everolimus 10 mg orally each day then 2 weeks of no medication until progression.

4 weeks of sunitinib 50 mg orally each day then 2 weeks of no medication until progression. At progression will crossover to everolimus.

4 weeks of everolimus of 10 mg orally each day then 2 weeks of no medication until progression. At progression will crossover to sunitinib.

4 weeks of sunitinib of 50 mg orally each day then 2 weeks of no medication until progression. At progression will crossover to everolimus.

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Papillary

Clear Cell with sarcomatoid features

Chromophobe

Translocation

Unclassified

Histology

Participants baseline ability for self-care, activity and physical ability: score 0-5. 0 is fully active. 1 is light house work and office work. 2 is cannot carry out work activities but up and about 50% of waking hours. 3 is limited to bed or chair more than 50% of waking hours 4. Completely disabled. 5. Dead

ECOG Performance Score

Good

Intermediate

Poor

Score based on participants performance score, time from diagnosis to treatment, hemoglobin count, lactate dehydrogenase level, and corrected calcium levels. O score is a good prognosis. 1 -2 is an intermediate prognosis, 3-5 is a poor prognosis

Memorial Sloan Kettering Risk Group

Score based on participant's time from diagnosis to treatment, performance score, hemoglobin counts calcium level, neutrophil count, and platelet count. 0 is a good risk. 1-2 is an intermediate risk. 3-5 is a poor risk.

International Metastatic RCC Database Consortium Risk Score for Renal Cell Carcinoma (RCC)

Amado Zurita-Saavedra,Associate Professor, Genitourinary Medical Oncology

Progression Free Survival (PFS) for First Line Medication

Progression Free Survival (PFS) for Crossover Medication

4 weeks of everolimus of 10 mg orally each day then 2 weeks of no medication until progression.

4 weeks of sunitinib of 50 mg orally each day then 2 weeks of no medication until progression.

Number of Participants Who Experienced Either a Grade 3 or 4 Adverse Event

Overall Survival of the First Line Therapy

Complete Response

Partial Response

Stable Disease

Progressive Disease

Number of Participants With Best Overall Response for First Line Medication

First Line Therapy

Crossover to Second Line Therapy

Sunitinib starting dose 50 mg by mouth daily given for 2 weeks "on" followed by 1 week "off". 1 cycle is 6 weeks.

Starting dose: 50 mg by mouth daily given for 2 weeks "on" followed by 1 week "off". 1 cycle is 6 weeks.

Questionnaire completion on Day 1 of Cycle 1, and on Day 35 of Cycles 2, 4, and 6.

Questionnaire

Eric Jonasch, MD

The goal of this clinical research study is to learn more about the safety of giving sunitinib to patients with metastatic kidney cancer for 2 weeks followed by 1 week in which they receive no drug. Researchers want to learn more about the side effects of the drug and the effects of a different dosing schedule.

Study Drug Administration:

If you are found to be eligible to take part in this study, you will take sunitinib capsules by mouth every day for 2 weeks, followed by 1 week in which you do not receive any study drug. This will then be repeated every 3 weeks.

Every 6 weeks will be 1 study cycle.

If you have any side effects tell the study doctor right away. The study doctor may change your dose of the study drug.

Study Visits:

Every day during the first week, and then at least 1 time each week during the study, your blood pressure will be checked (either at home, at the clinic, or by your local doctor). You will need to write down your blood pressure in a blood pressure diary each time you check it and bring the diary with you to each clinic visit.

On Day 1 of Cycle 1:

* You will have a physical exam.
* Blood (about 3-4 tablespoons) will be drawn for routine and biomarker testing.
* You will fill out a questionnaire about the quality of your life and about how you are feeling. This should take about 5 minutes.

On Day 42 of every cycle:

* You will have a physical exam.
* Blood (about 3-4 tablespoons) will be drawn for routine tests.

On Day 42 of every even-numbered cycle (Cycles 2, 4, 6, and so on):

* You will have a CT scan of your chest, abdomen, and pelvis.
* Blood (about 1 tablespoon) will be drawn to check your thyroid function.
* Blood (about 2 tablespoons) will be drawn for biomarker testing. (Cycles 2 , 4, and 6 only)
* You will fill out the questionnaire about the quality of your life and about how you are feeling. (Cycles 2 , 4, and 6 only)

At any time that the doctor thinks it is needed, additional blood (about 1 tablespoon) may be drawn to check your thyroid function, and you may need to have a bone scan and CT scan or MRI of the brain to check the status of the disease.

Length of Study:

You may continue taking the study drug for as long as the study doctor thinks it is in your best interest. You will be taken off treatment if the disease gets worse, intolerable side effects occur, or if you are unable to follow study directions.

Your participation in this study will be over after the follow-up visit. However, the study team may perform a medical record review or follow-up call to check on how you are doing. If you are called, this should last about 5-10 minutes.

End-of-Treatment Visit:

After you are no longer receiving the study drug, you will have an end-of-treatment visit. You will have a physical exam and blood (about 3-4 tablespoons) will be drawn for routine and biomarker testing.

End-of- Treatment Follow-Up Visit:

About 30 days after your end-of-treatment visit you will have a follow-up visit and the following procedures will be performed:

* You will have a physical exam.
* Blood (about 3-4 tablespoons) will be drawn for routine tests.
* You will have CT scans of your chest, abdomen and pelvis to check the status of the disease.

This is an investigational study. Sunitinib is FDA approved and commercially available to treat advanced kidney cancer. The dosing schedule being used on this study is investigational.

Up to 60 participants will be enrolled in this study. Up to 60 may take part at MD Anderson.

Sunitinib Scheduling in Metastatic Renal Cell Carcinoma (mRCC)

A Phase II Study of Alternative Sunitinib Scheduling in Patients With Metastatic Renal Cell Carcinoma (mRCC)

Determine the number of participants who experience a specific, treatment-related adverse events at a grade three, four or five: fatigue, hand-foot syndrome, and/or diarrhea. Adverse events as defined by the Common Terminology Criteria for Adverse Events (CTCAE) version 4

Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions

Adverse events as defined by Common Terminology Criteria for Adverse Events (CTCAE) version 4

Reported as the number and percentage of participants who underwent one or more dose reductions, as well as, the number and percentage of participants whose treatment ended.

Participants completed FACT-G suveys evaluating quality of life at weeks 0, 12, 24, and 36. The score range is from 0 to 180 with higher scores reflecting a better quality of life. The results were reported for each time point for all participants and then broken into two groups: participants with a grade 3 toxicity and participants without a grade 3 toxicity. The total number of surveys changes as the weeks progress.

Pfizer

Sunitinib starting dose 50 mg by mouth daily given for 2 weeks "on" followed by 1 week "off". 1 cycle is 6 weeks.

Sunitinib: Starting dose: 50 mg by mouth daily given for 2 weeks "on" followed by 1 week "off". 1 cycle is 6 weeks.

Questionnaire: Questionnaire completion on Day 1 of Cycle 1, and on Day 35 of Cycles 2, 4, and 6.

Unknown

Method used to predict survivability of participants at outset of treatment

Memorial Sloan Kettering Cancer Center (MSKCC) Risk Factor

Describes the extent of the participants' advance disease

Number of Metastatic Sites

Lung

Lymph node

Liver

Bone

Other

Metastatic Sites

Dr. Eric Jonasch, MD/Professor, Genitourinary Medical Oncology

Grade>=3, of all 3 adverse events

Fatigue, Grade >=3

Diarrhea, Grade >=3

Hand-foot syndrome, Grade >=3

Starting dose of 50 mg by mouth daily for 2 weeks followed by 1 week of no drug. 1 cycle equaled six weeks.

Alternating Sunitinib

Rate of Toxicity

Progression-Free Survival (PFS)

Any grade ≥3 event

Alkaline phosphatase increased

Anemia

Dehydration

Diarrhea

Fatigue

Pancreatic insufficiency

Headache

Hypertension

Hyponatremia

Hypophosphatemia

Lymphocyte count decreased

Mucositis oral

Gout

Neutrophil count decreased

Hand-foot syndrome

Platelet count decreased

Thromboembolic event

Urticaria

Vascular access complication

Vomiting

White blood cell decreased

The Number and Percentage of Participants Who Experienced a Grade 3, 4, or 5 Adverse Event

1 Dose Reduction

2 Dose Reductions

3 Dose Reductions

4 Dose Reductions

Out of the 59 participants only 29 encountered a dose reduction. The number of dose reductions a participant experienced was also reported with the percentage being based on the 29 participants who had a reduction.

Dose Reductions and Treatment Discontinuations Due to Unacceptable Toxicities

All Participants- week 0

All Participants- week 12

All Participants- week 24

All Participants- week 36

Grade 3 tox - week 0

Grade 3 tox - week 12

Grade 3 tox - week 24

Grade 3 tox - week 36

No grade 3 tox - week 0

No grade 3 tox - week 12

No grade 3 tox - week 24

No grade 3 tox - week 36

The number of surveys collected at week 0, 12,24, and 36 are 54, 49, 44, and 35 surveys.The number of surveys with a grade 3 toxicity collected at week 0, 12, 24, and 36 are 14, 11, 12, and 10 surveys. The number of surveys without a grade 3 toxicity collected at week 0, 12, 24, and 36 are 40, 38, 32, and 25 surveys.

Changes in Participant Reported Outcomes in the Functional Assessment of Cancer Therapy-General (FACT-G)

Data were not collected due to timing and budgetary issues.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Everolimus Versus Sunitinib in Non-Clear Cell Renal Cell Carcinoma	NCT01185366	Kidney Cancer	Everolimus Sunitinib	18 Years -	M.D. Anderson Cancer Center
Sunitinib Scheduling in Metastatic Renal Cell Carcinoma (mRCC)	NCT02060370	Genitourinary C... Kidney Cancer	Sunitinib Questionnaire	18 Years -	M.D. Anderson Cancer Center
Sunitinib Scheduling in Metastatic Renal Cell Carcinoma (mRCC)	NCT02060370	Genitourinary C... Kidney Cancer	Sunitinib Questionnaire	18 Years -	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for suo11248

Every month we try and update this database with for suo11248 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 suo11248

Every month we try and update this database with for suo11248 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 suo11248 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.