Overview

This trial is active, not recruiting.

Conditions genitourinary cancer, kidney cancer
Treatments sunitinib, questionnaire
Phase phase 2
Targets VEGF, FLT-3, KIT, PDGF
Sponsor M.D. Anderson Cancer Center
Collaborator Pfizer
Start date August 2014
End date August 2021
Trial size 60 participants
Trial identifier NCT02060370, 2013-0944, NCI-2014-01908

Summary

The standard method for giving sunitinib is 4 weeks in which the participant receives the drug every day, followed by 2 weeks in which the participant 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 participants 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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Sunitinib starting dose 50 mg by mouth daily given for 2 weeks "on" followed by 1 week "off". 1 cycle is 6 weeks.
sunitinib Sunitinib Malate
Starting dose: 50 mg by mouth daily given for 2 weeks "on" followed by 1 week "off". 1 cycle is 6 weeks.
questionnaire Survey
Questionnaire completion on Day 1 of Cycle 1, and on Day 35 of Cycles 2, 4, and 6.

Primary Outcomes

Measure
Rate of Toxicity
time frame: 12 weeks

Secondary Outcomes

Measure
Progression-Free Survival (PFS)
time frame: Day 35 of second, 12 week cycle

Eligibility Criteria

Male or female participants at least 18 years old.

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 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

Additional Information

Official title A Phase II Study of Alternative Sunitinib Scheduling in Patients With Metastatic Renal Cell Carcinoma (mRCC)
Principal investigator Eric Jonasch, MD
Description Study Drug Administration: If participant is found to be eligible to take part in this study, they will take sunitinib capsules by mouth every day for 2 weeks, followed by 1 week in which they do not receive any study drug. This will then be repeated every 3 weeks. Every 6 weeks will be 1 study cycle. If participant has any side effects they should tell the study doctor right away. The study doctor may change participant's dose of the study drug. Study Visits: Every day during the first week, and then at least 1 time each week during the study, participant's blood pressure will be checked (either at home, at the clinic, or by their local doctor). Participant will need to write down their blood pressure in a blood pressure diary each time they check it and bring the diary with them to each clinic visit. On Day 1 of Cycle 1: - Participant will have a physical exam. - Blood (about 3-4 tablespoons) will be drawn for routine and biomarker testing. - Participant will fill out a questionnaire about the quality of their life and about how they are feeling. This should take about 5 minutes. On Day 42 of every cycle: - Participant 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): - Participant will have a CT scan of their chest, abdomen, and pelvis. - Blood (about 1 tablespoon) will be drawn to check participant's thyroid function. - Blood (about 2 tablespoons) will be drawn for biomarker testing. (Cycles 2 , 4, and 6 only) - Participant will fill out the questionnaire about the quality of their life and about how they 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 participant's thyroid function, and they 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: Participant may continue taking the study drug for as long as the study doctor thinks it is in their best interest. Participant will be taken off study if the disease gets worse, intolerable side effects occur, or if they are unable to follow study directions. Patient's participation in this study will be over after the follow-up visit. End-of-Treatment Visit: After participant is no longer receiving the study drug, they will have an end-of-treatment visit. Participant will have a physical exam and blood (about 3-4 tablespoons) will be drawn for routine and biomarker testing. End-of-Study Follow-Up Visit: About 30 days after participant's end-of-treatment visit they will have a follow-up visit and the following procedures will be performed: - Participant will have a physical exam. - Blood (about 3-4 tablespoons) will be drawn for routine tests. - Participant will have CT scans of their 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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by M.D. Anderson Cancer Center.
Location data was received from the National Cancer Institute and was last updated in November 2016.