Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Sunitinib Scheduling in Metastatic Renal Cell Carcinoma (mRCC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02060370
Recruitment Status : Completed
First Posted : February 12, 2014
Results First Posted : February 27, 2020
Last Update Posted : February 27, 2020
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Tracking Information
First Submitted Date  ICMJE February 10, 2014
First Posted Date  ICMJE February 12, 2014
Results First Submitted Date  ICMJE January 2, 2020
Results First Posted Date  ICMJE February 27, 2020
Last Update Posted Date February 27, 2020
Actual Study Start Date  ICMJE August 2014
Actual Primary Completion Date January 2, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 14, 2020)
Rate of Toxicity [ Time Frame: Participants were monitored for toxicities for 30 days after treatment was discontinued; total treatment duration approximately 34 months ]
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
Original Primary Outcome Measures  ICMJE
 (submitted: February 11, 2014)
Rate of Toxicity [ Time Frame: 12 weeks ]
Composite rate of toxicity defined as percentage of patients who experience one or more of the following ≥grade 3 toxicities using CTCAE version 4.03 criteria that are possibly, probably, or definitely related to study therapy: fatigue, hand-foot syndrome (HFS), or diarrhea.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 14, 2020)
  • Progression-Free Survival (PFS) [ Time Frame: 17 months ]
    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
  • The Number and Percentage of Participants Who Experienced a Grade 3, 4, or 5 Adverse Event [ Time Frame: Participants were monitored for toxicities for 30 days after treatment was discontinued or until death, whichever occurred first. ]
    Adverse events as defined by Common Terminology Criteria for Adverse Events (CTCAE) version 4
  • Dose Reductions and Treatment Discontinuations Due to Unacceptable Toxicities [ Time Frame: 2 years ]
    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.
  • Changes in Participant Reported Outcomes in the Functional Assessment of Cancer Therapy-General (FACT-G) [ Time Frame: 36 weeks from the start of treatment ]
    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.
  • Changes in Circulating DNA Levels With Antiangiogenic Treatment [ Time Frame: Not applicable due data not generated due to timing and budgetary issues ]
Original Secondary Outcome Measures  ICMJE
 (submitted: February 11, 2014)
Progression-Free Survival (PFS) [ Time Frame: Day 35 of second, 12 week cycle ]
Progression-free survival (PFS) defined as time from treatment initiation to disease progression using RECIST v 1 or death. PFS measured from the date of initiation of treatment to the first of documented progression or death; and estimated using the Kaplan-Meier method.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Sunitinib Scheduling in Metastatic Renal Cell Carcinoma (mRCC)
Official Title  ICMJE A Phase II Study of Alternative Sunitinib Scheduling in Patients With Metastatic Renal Cell Carcinoma (mRCC)
Brief 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Genitourinary Cancer
  • Kidney Cancer
Intervention  ICMJE
  • Drug: Sunitinib
    Starting dose: 50 mg by mouth daily given for 2 weeks "on" followed by 1 week "off". 1 cycle is 6 weeks.
    Other Names:
    • Sunitinib Malate
    • SUO11248
    • Sutent
  • Behavioral: Questionnaire
    Questionnaire completion on Day 1 of Cycle 1, and on Day 35 of Cycles 2, 4, and 6.
    Other Name: Survey
Study Arms  ICMJE Experimental: Sunitinib
Sunitinib starting dose 50 mg by mouth daily given for 2 weeks "on" followed by 1 week "off". 1 cycle is 6 weeks.
Interventions:
  • Drug: Sunitinib
  • Behavioral: Questionnaire
Publications * Jonasch E, Slack RS, Geynisman DM, Hasanov E, Milowsky MI, Rathmell WK, Stovall S, Juarez D, Gilchrist TR, Pruitt L, Ornstein MC, Plimack ER, Tannir NM, Rini BI. Phase II Study of Two Weeks on, One Week off Sunitinib Scheduling in Patients With Metastatic Renal Cell Carcinoma. J Clin Oncol. 2018 Jun 1;36(16):1588-1593. doi: 10.1200/JCO.2017.77.1485. Epub 2018 Apr 11.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 11, 2014)
60
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2, 2019
Actual Primary Completion Date January 2, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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) </= 2.5 x laboratory upper limit of normal (ULN); Total serum bilirubin </= 2.0 x ULN; Absolute neutrophil count (ANC) >/= 1500/µL; Platelets >/= 100,000/µL; Hemoglobin >/= 9.0 g/dL (transfusion permitted); Serum calcium </= 12.0 mg/dL; Serum creatinine </= 2.5 mg/dL
  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 intraabdominal, 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02060370
Other Study ID Numbers  ICMJE 2013-0944
NCI-2014-01908 ( Registry Identifier: NCI CTRP )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party M.D. Anderson Cancer Center
Study Sponsor  ICMJE M.D. Anderson Cancer Center
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator: Eric Jonasch, MD M.D. Anderson Cancer Center
PRS Account M.D. Anderson Cancer Center
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP