Sunitinib Scheduling in Metastatic Renal Cell Carcinoma (mRCC)
Conditions
Genitourinary Cancer - Kidney Cancer
Conditions: official terms
Carcinoma, Renal Cell - Kidney Neoplasms - Urogenital Neoplasms
Conditions: Keywords
Genitourinary Cancer, Kidney Cancer, Metastatic Renal Cell Carcinoma, mRCC, Sunitinib, Sunitinib malate, SUO11248, Sutent, Questionnaire, Survey
Study Type
Interventional
Study Phase
Phase 2
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Sunitinib Type: Drug
Name: Questionnaire Type: Behavioral
Overall Status
Recruiting
Summary
The standard method for giving sunitinib is 4 weeks in which the patient receives the drug every day, followed by 2 weeks in which the patient receives no drug. These 6 week cycles are then repeated. However, side effects are often seen to increase and get worse during the 4 weeks of treatment, especially during the last 2 weeks. Researchers want to learn if shortening the treatment cycles can help to decrease the frequency and severity of side effects.

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. The side effects from and effectiveness of this dosing schedule will be studied and compared to those of the standard.
Detailed Description
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 study 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.

End-of-Treatment Visit:

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

End-of-Study 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:

- 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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

1. Histologically or cytologically-confirmed metastatic renal cell carcinoma of clear cell histology. Prior nephrectomy is not a requirement for eligibility

2. Age >/=18 years

3. Measurable or evaluable metastatic disease per RECIST v 1

4. ECOG performance status 0-1

5. Normal organ and bone marrow function as defined by: Serum aspartate transaminase (AST) or serum glutamic oxaloacetic transaminase (SGOT) and serum alanine transaminase (ALT) or serum glutamic pyruvic transaminase (SGPT) /= 1500/µL; Platelets >/= 100,000/µL; Hemoglobin >/= 9.0 g/dL (transfusion permitted); Serum calcium
6. Patients with a history of deep venous thromboembolism or pulmonary embolism on treatment with anticoagulation are eligible for the study.

7. Subjects must have the ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

1. Prior treatment with sunitinib or any other systemic therapy in the metastatic setting (prior neo/adjuvant therapy will be allowed if completed > 6 months prior to registration and therapy not discontinued for toxicity)

2. Uncontrolled hypertension (defined as blood pressure >140/90 mm Hg not controlled with anti-hypertensives)

3. Prior intrabdominal, intrathoracic, vascular, spinal or intracranial surgery or radiation therapy within 4 weeks of starting treatment

4. History of or known brain metastases, spinal cord compression, or carcinomatous meningitis

5. New York Heart Association (NYHA) grade II or greater congestive heart failure

6. Current treatment on another therapeutic clinical trial

7. Any of the following within the preceding 6 months- myocardial infarction, severe/unstable angina, severe peripheral vascular disease (claudication) or procedure on peripheral vasculature, coronary/peripheral artery bypass, graft, cerebrovascular accident or transient ischemic attack, clinically significant bleeding

8. Pregnant or breastfeeding women are excluded from this study because there is an unknown, but potential risk for adverse events in nursing infants secondary to treatment of the mother with sunitinib. Breastfeeding must be discontinued if the mother is treated with sunitinib

9. Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness

10. HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with sunitinib. In addition, these patients are at increased risk of lethal infections when treated with marrow suppressive therapy
Locations
Stanford University Medical Center
Stanford, California, United States
Status: Recruiting
Lineberger Cancer Center
Chapel Hill, North Carolina, United States
Status: Recruiting
Cleveland Clinic Taussig Cancer Institute
Cleveland, Ohio, United States
Status: Recruiting
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
Status: Recruiting
University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Status: Recruiting
Start Date
August 2014
Sponsors
M.D. Anderson Cancer Center
Source
M.D. Anderson Cancer Center
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page