AZD2171 in Treating Patients With Refractory Metastatic Kidney Cancer
Condition: Clear Cell Renal Cell Carcinoma; Recurrent Renal Cell Cancer; Stage IV Renal Cell Cancer
MeSH terms: Carcinoma; Carcinoma, Renal Cell
Intervention: cediranib maleate; laboratory biomarker analysis
Intervention description: Given orally; Correlative studies
Intervention MeSH terms: Cediranib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This phase II trial is studying how well AZD2171 works in treating patients with refractory
      metastatic kidney cancer. AZD2171 may stop the growth of tumor cells by blocking some of the
      enzymes needed for cell growth and by blocking blood flow to the tumor.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically confirmed clear cell renal cell cancer

               -  Must be predominantly metastatic disease

               -  Refractory disease

          -  Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mmby
             conventional techniques or ≥ 10 mm by spiral CT scan

          -  No known brain metastases

          -  ECOG performance status 0-2

          -  Karnofsky 60-100%

          -  WBC ≥ 3,000/mm^3

          -  Absolute neutrophil count ≥ 1,500/mm^3

          -  Platelet count ≥ 100,000/mm^3

          -  Hemoglobin ≥ 8.0 g/dL

          -  AST and ALT ≤ 2.5 times upper limit of normal (ULN)

          -  Bilirubin normal

          -  Creatinine normal OR creatinine clearance > 60 mL/min

          -  Blood pressure < 140/90 mm Hg on 2 separate occasions not more than 6 weeks prior to
             enrollment and not less than 24 hours apart (stable antihypertensive regimen allowed)

          -  Mean QTc ≤ 470 msec (with Bazett's correction)

          -  Less than +1 proteinuria on two consecutive dipsticks taken no less than 1 week apart

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  No history of familial long QT syndrome

          -  No cardiac arrhythmia

          -  No unstable angina pectoris

          -  No symptomatic congestive heart failure

          -  No New York Heart Association class III or IV disease

          -  No ongoing or active infection

          -  No hypertension

          -  No other uncontrolled intercurrent illness

          -  No history of allergic reactions attributed to compounds of similar chemical or
             biologic composition to AZD2171

          -  No psychiatric illness or social situations that would limit compliance with study
             requirements

          -  See Disease Characteristics

          -  More than 4 weeks since prior radiotherapy and recovered

          -  More than 4 weeks since prior major surgery and recovered

          -  More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C)
             and recovered

          -  More than 30 days since other prior investigational agents

          -  No prior therapy with vascular endothelial growth factor (VEGF) binding agents or VEGF
             receptor (VEGFR) tyrosine kinase inhibitors

          -  No more than 1 prior nonVEGF-directed systemic therapy for this disease

          -  No concurrent medication that may markedly affect renal function (e.g., vancomycin,
             amphotericin, ibuprofen, pentamidine)

          -  No combination antiretroviral therapy for HIV-positive patients

          -  No concurrent hematopoietic growth factors except epoetin alfa and bisphosphonates

          -  No concurrent hormones or other chemotherapeutic agents except for steroids given for
             adrenal failure and hormones administered for nondisease-related conditions (e.g.
             insulin for diabetes)

          -  No concurrent palliative or therapeutic radiation therapy

          -  No concurrent drugs or biologics with proarrhythmic potential

          -  No other concurrent investigational or commercial agents or therapies to treat the
             patient's malignancy