Sunitinib Malate in Treating Patients With Previously Untreated Metastatic Kidney Cancer
Condition: Clear Cell Renal Cell Carcinoma; Stage IV Renal Cell Cancer
MeSH terms: Carcinoma; Carcinoma, Renal Cell
Intervention: sunitinib malate
Intervention description: Given orally
Intervention MeSH terms: Sunitinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 37.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      RATIONALE: Sunitinib malate may stop the growth of tumor cells by blocking some of the
      enzymes needed for cell growth or by blocking blood flow to the tumor.

      PURPOSE: This phase II trial is studying how well sunitinib malate it works in treating
      patients with previously untreated metastatic kidney cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically-proven advanced RCC with a component of clear cell
             histology

          -  Measurable disease per RECIST criteria

          -  ECOG performance status 0-1

          -  Prior nephrectomy is NOT required

          -  Serum aspartate transaminase (AST; serum glutamic oxaloacetic transaminase [SGOT]) and
             serum alanine transaminase (ALT; 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/uL

          -  Platelets ≥ 100,000/uL

          -  Hemoglobin ≥ 8.0 g/dL (transfusion permitted)

          -  Serum calcium ≤ 12.0 mg/dL

          -  Serum creatinine ≤ 2.5 mg/dL

          -  Patients with history of brain metastases can be enrolled at a minimum of 2 weeks
             following the completion of surgery, gamma knife or whole brain radiotherapy; repeat
             brain MRI not required for eligibility

          -  Signed and dated informed consent document indicating that the patient (or legally
             acceptable representative) has been informed of all pertinent aspects of the trial
             prior to enrollment

        Exclusion Criteria:

          -  Prior systemic treatment for advanced RCC. Prior adjuvant therapy (any drug) is
             allowed if end of adjuvant therapy was more than 1 year prior to start of sunitinib on
             this protocol.

          -  Any of the following within the 6 months prior to study drug administration:
             myocardial infarction, severe/unstable angina, severe peripheral vascular disease
             (claudication) or procedure on peripheral vasculature, coronary/peripheral artery
             bypass graft, New York Heart Association grade II or greater congestive heart failure,
             cerebrovascular accident or transient ischemic attack, clinically significant bleeding
             or pulmonary embolism

          -  Hypertension that cannot be controlled by medications to < 160/90 mmHg

          -  Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome
             (AIDS)-related illness

          -  Pregnancy or breastfeeding

          -  Other severe acute or chronic medical or psychiatric conditions or laboratory
             abnormality that may increase the risk associated with study participation or study
             drug administration, or may interfere with the interpretation of study results, and in
             the judgment of the investigator would make the patient inappropriate for entry into
             this study