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AZD2171 in Treating Patients With Progressive Locally Recurrent or Metastatic Kidney Cancer That Cannot Be Removed By Surgery
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: Princess Margaret Hospital, Canada
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00227760
  Purpose

RATIONALE: AZD2171 may stop the growth of tumor cells by blocking blood flow to the tumor and by blocking some of the enzymes needed for cell growth.

PURPOSE: This phase II trial is studying AZD2171 to see how well it works in treating patients with progressive locally recurrent or metastatic kidney cancer that cannot be removed by surgery.


Condition Intervention Phase
Kidney Cancer
Drug: cediranib maleate
Phase II

MedlinePlus related topics: Cancer Kidney Cancer
Drug Information available for: Cediranib
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: A Phase 2 Study of AZD2171 in Progressive Unresectable, Recurrent or Metastatic Renal Cell Carcinoma

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Objective response rate and rate of stable disease ≥ 4 months [ Designated as safety issue: No ]
  • Duration of response or stable disease [ Designated as safety issue: No ]
  • Progression-free, median, and overall survival [ Designated as safety issue: No ]
  • Safety and tolerability [ Designated as safety issue: Yes ]
  • Correlation of levels of soluble markers of angiogenic growth factors and receptors and circulating endothelial cells with clinical outcome [ Designated as safety issue: No ]
  • Correlation of changes in blood flow and vessel permeability with clinical outcome [ Designated as safety issue: No ]

Estimated Enrollment: 37
Study Start Date: December 2005
Estimated Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • Determine the clinical benefit rate (objective response rate and rate of stable disease for ≥ 4 months) in patients with progressive unresectable, locally recurrent or metastatic renal cell carcinoma treated with AZD2171.
  • Determine the duration of response or stable disease in patients treated with this drug.
  • Determine progression-free, median, and overall survival of patients treated with this drug.
  • Determine the safety and tolerability of this drug in these patients.
  • Correlate levels of soluble markers of angiogenic growth factors and receptors and circulating endothelial cells with clinical outcome in patients treated with this drug.
  • Correlate changes in blood flow and vessel permeability with clinical outcome in patients treated with this drug.

OUTLINE: This is a multicenter study.

Patients receive oral AZD2171 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed at 4 weeks and then every 3 months thereafter.

PROJECTED ACCRUAL: A total of 12-37 patients will be accrued for this study within 4-12 months.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed renal cell cancer

    • Locally recurrent or metastatic disease
    • Progressive unresectable disease
    • Not considered curable by standard therapy
  • Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques or ≥ 10 mm by spiral CT scan

    • Bone lesions are not considered measurable disease
    • Sole site of measurable disease may lie within a previously irradiated field provided there has been subsequent documented disease progression
  • No known brain metastases

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-2 OR
  • Karnofsky 60-100%

Life expectancy

  • More than 3 months

Hematopoietic

  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3

Hepatic

  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • AST and ALT ≤ 3 times ULN

Renal

  • Creatinine ≤ 1.5 times ULN OR
  • Creatinine clearance ≥ 60 mL/min
  • No proteinuria > +1 on 2 consecutive dipstick tests taken ≥ 1 week apart

Cardiovascular

  • QTc ≤ 470 msec (with Bazett's correction) by ECG
  • No history of familial long QT syndrome
  • No hypertension
  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • No cardiac arrhythmia
  • No New York Heart Association class III or IV disease

    • Class II disease with increased monitoring is allowed

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No history of allergic reaction attributed to compounds of similar chemical or biological composition to study drug
  • No ongoing or active infection
  • No psychiatric illness or social situation that would preclude study compliance
  • No other uncontrolled illness

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No prior immunotherapy or gene therapy
  • No drugs or biologics with proarrythmic potential

Chemotherapy

  • No prior systemic chemotherapy

Endocrine therapy

  • Not specified

Radiotherapy

  • See Disease Characteristics
  • At least 4 weeks since prior radiotherapy, except low-dose, non-myelosuppressive radiotherapy, and recovered
  • No concurrent radiotherapy to the sole site of measurable disease

Surgery

  • At least 4 weeks since prior major surgery and recovered

Other

  • No prior investigational therapy
  • No prior participation in another investigational study
  • No other concurrent investigational agents
  • No concurrent combination antiretroviral therapy for HIV-positive patients
  • No other concurrent anticancer therapy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00227760

Locations
Canada, Alberta
Cross Cancer Institute at University of Alberta
Edmonton, Alberta, Canada, T6G 1Z2
Canada, British Columbia
British Columbia Cancer Agency - Vancouver Cancer Centre
Vancouver, British Columbia, Canada, V5Z 4E6
Canada, Ontario
London Regional Cancer Program at London Health Sciences Centre
London, Ontario, Canada, N6A 4L6
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Ottawa Hospital Regional Cancer Centre - General Campus
Ottawa, Ontario, Canada, K1H 8L6
Margaret and Charles Juravinski Cancer Centre
Hamilton, Ontario, Canada, L8V 5C2
Sponsors and Collaborators
Princess Margaret Hospital, Canada
Investigators
Study Chair: Srikala Sridhar, MD, FRCPC, MSC Princess Margaret Hospital, Canada
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Publications of Results:
Sridhar SS, Mackenzie MJ, Hotte SJ, et al.: AZD2171 (cediranib) is active in first line metastatic renal cell carcinoma (RCC): interim results of a phase II trial. A trial of the PMH phase II Consortium. [Abstract] American Association for Cancer Research: Molecular Targets and Cancer Therapeutics, October 22-26, 2007, San Francisco, CA A-10, 2007.

Study ID Numbers: CDR0000446080, PMH-PHL-039, NCI-7128
Study First Received: September 26, 2005
Last Updated: December 6, 2008
ClinicalTrials.gov Identifier: NCT00227760  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent renal cell cancer
stage IV renal cell cancer

Study placed in the following topic categories:
Urogenital Neoplasms
Renal cancer
Urologic Neoplasms
Kidney cancer
Recurrence
Carcinoma
Urologic Diseases
Kidney Neoplasms
Carcinoma, Renal Cell
Kidney Diseases
Adenocarcinoma
Urinary tract neoplasm
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on January 16, 2009