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


Phase 2
18 Years
N/A
Not Enrolling
Both
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


PRIMARY OBJECTIVES:

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

SECONDARY OBJECTIVES:

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
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

Type of Study:

Interventional

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:

No

Principal Investigator

Walter Stadler

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Chicago Comprehensive Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2012-02686

NCT ID:

NCT00303862

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

Name

Location

University of Chicago Comprehensive Cancer CenterChicago, Illinois  60637-1470