Sunitinib Scheduling in Metastatic Renal Cell Carcinoma (mRCC)

NCT02060370

Last updated date
Study Location
Stanford University Medical Center
Stanford, California, 94305, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Genitourinary Cancer, Kidney Cancer
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


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

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Genitourinary Cancer, Kidney CancerSunitinib Scheduling in Metastatic Renal Cell Carcinoma (mRCC)
NCT02060370
  1. Stanford, California
  2. Chapel Hill, North Carolina
  3. Cleveland, Ohio
  4. Philadelphia, Pennsylvania
  5. Houston, Texas
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
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, MDM.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