AZD2171 in Treating Patients With Refractory Metastatic Kidney Cancer

NCT ID: NCT00303862

Last Updated: 2014-05-21

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-03-31
• Study Completion Date: 2011-03-31

Brief Summary

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.

Detailed Description

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.

Conditions

Clear Cell Renal Cell Carcinoma; Recurrent Renal Cell Cancer; Stage IV Renal Cell Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

cediranib maleate

Intervention Type: DRUG

Given orally

laboratory biomarker analysis

Intervention Type: OTHER

Correlative studies

Interventions

cediranib maleate

Given orally

Intervention Type: DRUG

laboratory biomarker analysis

Correlative studies

Intervention Type: OTHER

Other Intervention Names

AZD2171; Recentin

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Walter Stadler

Role: PRINCIPAL_INVESTIGATOR

University of Chicago

Locations

University of Chicago

Chicago, Illinois, United States

Countries

United States

Other Identifiers

NCI-2012-02686

Identifier Type: REGISTRY

Identifier Source: secondary_id

CDR0000460237

Identifier Type: -

Identifier Source: secondary_id

UCCRC-NCI-7111

Identifier Type: -

Identifier Source: secondary_id

NCI-7111

Identifier Type: -

Identifier Source: secondary_id

14018A

Identifier Type: OTHER

Identifier Source: secondary_id

7111

Identifier Type: OTHER

Identifier Source: secondary_id

P30CA014599

Identifier Type: NIH

Identifier Source: secondary_id

View Link

N01CM62201

Identifier Type: NIH

Identifier Source: secondary_id

View Link

N01CM62209

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NCI-2012-02686

Identifier Type: -

Identifier Source: org_study_id