Clinical trial NCT00480935 (phase 2, status: terminated)
Conditions: renal cell carcinoma
ICD codes: C22.0, C4A.9, C7B.1, C4A.0, C4A.31, C4A.51, C4A.8
Drugs: sunitinib malate (sutent)
SMILES: CCN(CC)CCNC(=O)C1=C(C)NC(\C=C2/C(=O)NC3=C2C=C(F)C=C3)=C1C
Reason stopped: 
    poor recruitment
  
Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed renal cell carcinoma with a component of clear (conventional)
             cell histology, which has been assessed with biopsy at screening.

          -  Locally confined tumour ≤ 7 cm

          -  Has not undergone nephrectomy and is a candidate for surgical treatment of renal cell
             carcinoma

          -  Male or female, 18 years of age or older

          -  ECOG performance status 0 or 1

          -  Adequate organ function as defined by the following criteria:

               -  Serum aspartate transaminase (AST; serum glutamic oxaloacetic transaminase
                  [SGOT]) and serum alanine transaminase (ALT; serum glutamic pyruvic transaminase
                  [SGPT]) less than or equal to 2.5 x central laboratory upper limit of normal
                  (CL-ULN), or AST and ALT less than or equal to 5 x CL ULN if liver function
                  abnormalities are due to underlying malignancy

               -  Total serum bilirubin less than or equal to 1.5 x CL-ULN

               -  Absolute neutrophil count (ANC) greater than or equal to 1500/mL

               -  Platelets greater than or equal to 100,000/mL

               -  Hemoglobin greater than or equal to 9.0 g/dL

               -  Serum calcium less than or equal to 12.0 mg/dL

               -  Serum creatinine less than or equal to 1.5 x CL-ULN

               -  Prothrombin time (PT) less than or equal to 1.5 x CL-ULN

          -  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:

          -  Prior therapy of any kind for RCC (including nephrectomy, immunotherapy, chemotherapy,
             radiation, hormonal, or investigational therapy)

          -  Abnormal ECG- including long QT/QTc interval, AV block or arrythmia

          -  Tumour associated with local extension into adjacent tissues

          -  Tumour associated with renal/vena caval thrombus

          -  Tumour associated with lymphadenopathy (lymph node > 1 cm)

          -  Evidence of rapidly progressive disease or other factors requiring surgery to take
             place before the 12 weeks scheduled for neoadjuvant treatment

          -  Major surgery within 4 weeks of commencing study treatment

          -  Any toxicity with a NCI CTCAE grade 3 or 4

          -  Diagnosis of any second malignancy within the last 5 years, except for adequately
             treated basal cell carcinoma, squamous cell skin cancer, or in situ cervical cancer

          -  Evidence of metastatic renal cell carcinoma

          -  Any of the following within the 12 months prior to study drug administration:
             myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass
             graft, symptomatic congestive heart failure, cerebrovascular accident or transient
             ischemic attack, or pulmonary embolism

          -  Pre-existing thyroid abnormality with thyroid function that cannot be maintained in
             the normal range with medication

          -  Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome
             (AIDS)-related illness

          -  Current treatment on another clinical trial

          -  Pregnancy or breastfeeding