Clinical trial NCT00303862 (phase 2, status: terminated)
Conditions: clear cell renal cell carcinoma, recurrent renal cell cancer, stage iv renal cell cancer
ICD codes: C22.0, C4A.9, C7B.1, C4A.0, C4A.31, C4A.51, C4A.8, C96.20, C96.29, D47.09, C96.20, C96.29, D47.09
Drugs: cediranib maleate
SMILES: COC1=CC2=C(C=C1OCCCN1CCCC1)N=CN=C2OC1=C(F)C2=C(NC(C)=C2)C=C1
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