Sunitinib in Treating Patients With Kidney Cancer That Cannot Be Removed by Surgery
Condition: Kidney Cancer
MeSH terms: Carcinoma, Renal Cell; Kidney Neoplasms
Intervention: sunitinib malate; conventional surgery
Intervention description: Sunitinib will be dosed at 50 mg p.o. daily; nephrectomy
Intervention MeSH terms: Sunitinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: clear cell renal cell carcinoma; stage III renal cell cancer; stage IV renal cell cancer; papillary renal cell carcinoma

Summary:

      RATIONALE: Sunitinib may stop the growth of kidney cancer by blocking blood flow to the tumor
      and by blocking some of the enzymes needed for cell growth.

      PURPOSE: This phase II trial is studying the side effects and how well sunitinib works in
      treating patients with kidney cancer that cannot be removed by surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically confirmed renal cell carcinoma (any histology) based
             on prior biopsy or biopsy performed and reviewed at Cleveland Clinic Foundation. This
             can include pathology read as adenocarcinoma consistent with renal origin.

          -  Unresectable primary tumor due to any of the following factors or various combinations
             thereof:

               -  Large tumor size (> 15 cm)

               -  Bulky lymphadenopathy (> 4 cm or encasement of renal vessels or great vessels)

               -  Venous thrombosis (high level/invasive disease requiring inferior vena cava
                  reconstruction or hypothermic circulatory arrest)

               -  Proximity to vital structures (e.g., mesenteric vasculature)

               -  Any one of these factors may or may not constitute unresectability, but for
                  consideration for this trial, the surgical and medical oncologist must agree that
                  the particular constellation of findings for the patient under consideration
                  would likely entail a low probability (<50%) that the tumor would be resectable
                  (with negative margins) or that the potential morbidity associated with an
                  attempt at surgical resection would not be clinically acceptable. The numerical
                  thresholds noted above are only a guideline and the clinical judgment of the
                  surgeon and medical oncologist will determine unresectability.

          -  Patients with history of brain metastases can be enrolled 2 weeks following the
             completion of gamma knife or whole brain radiotherapy.

          -  ECOG performance status (PS) 0-1 or Karnofsky PS >/=70%

          -  Serum aspartate transaminase (AST; serum glutamic oxaloacetic transaminase [SGOT]) and
             serum alanine transaminase (ALT; serum glutamic pyruvic transaminase [SGPT]) ≤ 2.5
             times upper limit of normal (ULN)

          -  Total Serum Bilirubin ≤ 1.5 times ULN

          -  Absolute neutrophil count ≥ 1,500/mm³

          -  Platelet count ≥ 100,000/mm³

          -  Hemoglobin ≥ 8.0 g/dL (transfusion allowed)

          -  Serum calcium ≤ 12.0 mg/dL

          -  Creatinine ≤ 2.5 mg/dL

          -  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

          -  Willingness and ability to comply with scheduled visits, treatment plans, laboratory
             tests, and other study procedures.

        Exclusion Criteria:

          -  The presence of any of the following will exclude a patient from study enrollment:

          -  Prior systemic treatment for RCC.

          -  Evidence of bleeding diathesis or coagulopathy. Patients with hematuria from the
             primary renal tumor are eligible provided all other eligibility criteria are met.

          -  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.