NCT02060370

Sunitinib Scheduling in Metastatic Renal Cell Carcinoma (mRCC)

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

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 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.

Conditions

• Genitourinary Cancer
• Kidney Cancer

Interventions

Type	Name	Description
DRUG	Sunitinib	Starting dose: 50 mg by mouth daily given for 2 weeks "on" followed by 1 week "off". 1 cycle is 6 weeks.
BEHAVIORAL	Questionnaire	Questionnaire completion on Day 1 of Cycle 1, and on Day 35 of Cycles 2, 4, and 6.

Timeline

• Start date: 2014-08-01
• Primary completion: 2019-01-02
• Completion: 2019-01-02
• First posted: 2014-02-12
• Last updated: 2020-02-27
• Results posted: 2020-02-27

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study