AZD2171 in Treating Patients With Refractory Metastatic Kidney Cancer

Stopped early · Phase 2

Conditions studied: Clear Cell Renal Cell Carcinoma, Recurrent Renal Cell Cancer, Stage IV Renal Cell Cancer

In brief

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.

Key facts

Study ID

NCT00303862

Run by

National Cancer Institute (NCI)

People needed

10

Starts

2006-03-01

Expected to finish

2011-03-01

Last updated by the study team

2014-05-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

Where it is running

• University of Chicago — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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