Sunitinib Scheduling in Metastatic Renal Cell Carcinoma (mRCC)
Condition: Genitourinary Cancer; Kidney Cancer
MeSH terms: Carcinoma; Carcinoma, Renal Cell; Kidney Neoplasms; Urogenital Neoplasms
Intervention: Sunitinib; Questionnaire
Intervention description: Starting dose: 50 mg by mouth daily given for 2 weeks "on" followed by 1 week "off". 1 cycle is 6 weeks.; Questionnaire completion on Day 1 of Cycle 1, and on Day 35 of Cycles 2, 4, and 6.
Intervention MeSH terms: Sunitinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Genitourinary Cancer; Kidney Cancer; Metastatic Renal Cell Carcinoma; mRCC; Sunitinib; Sunitinib malate; SUO11248; Sutent; Questionnaire; Survey

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.
    

Eligibility 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) </= 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