AZD2171 in Treating Patients With Refractory Metastatic Kidney Cancer
Clear Cell Renal Cell Carcinoma, Recurrent Renal Cell Cancer, Stage IV Renal Cell Cancer
About this trial
This is an interventional treatment trial for Clear Cell Renal Cell Carcinoma
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
Sites / Locations
- University of Chicago
Arms of the Study
Arm 1
Experimental
Treatment (cediranib maleate)
Patients receive oral AZD2171 once daily for 4 weeks. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.