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A Phase 2 Study of AZD2171 in Patients With Advanced Renal Cell Carcinoma

Phase 2
18 Years
Not Enrolling
Clear Cell Renal Cell Carcinoma, Recurrent Renal Cell Cancer, Stage IV Renal Cell Cancer

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Trial Information

A Phase 2 Study of AZD2171 in Patients With Advanced Renal Cell Carcinoma


I. Determine the objective response rate in patients with refractory metastatic renal cell
carcinoma treated with AZD2171.


I. Determine the safety and tolerability of AZD2171 in these patients. II. Determine the
feasibility of performing standardized delayed contrast-enhancement-MRI correlative studies
across different institutions and platforms with data-sharing capability in patients with
metastatic renal cell cancer.

III. Generate preliminary data regarding potential utility of pharmacogenomic and
plasma/serum biomarkers of angiogenesis as predictive or prognostic markers for future
investigations of AZD2171 and renal cell carcinoma.

OUTLINE: This is a multicenter study.

Patients receive oral AZD2171 once daily for 4 weeks. Treatment repeats every 4 weeks in the
absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed for 6 weeks.

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

- 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

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective radiologic response as measured by RECIST criteria

Outcome Time Frame:

Up to 6 weeks

Safety Issue:


Principal Investigator

Walter Stadler

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Chicago Comprehensive Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

March 2006

Completion Date:

Related Keywords:

  • Clear Cell Renal Cell Carcinoma
  • Recurrent Renal Cell Cancer
  • Stage IV Renal Cell Cancer
  • Carcinoma
  • Carcinoma, Renal Cell



University of Chicago Comprehensive Cancer Center Chicago, Illinois  60637-1470