AZD2171 in Treating Patients With Progressive Locally Recurrent or Metastatic Kidney Cancer That Cannot Be Removed By Surgery

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2007 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00227760
First received: September 26, 2005
Last updated: September 5, 2012
Last verified: September 2007
  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 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 2 Study of AZD2171 in Progressive Unresectable, Recurrent or Metastatic Renal Cell Carcinoma

Resource links provided by NLM:


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: May 2013 (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
Margaret and Charles Juravinski Cancer Centre
Hamilton, Ontario, Canada, L8V 5C2
London Regional Cancer Program at London Health Sciences Centre
London, Ontario, Canada, N6A 4L6
Ottawa Hospital Regional Cancer Centre - General Campus
Ottawa, Ontario, Canada, K1H 8L6
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
Princess Margaret Hospital, Canada
Investigators
Study Chair: Srikala Sridhar, MD, FRCPC, MSC Princess Margaret Hospital, Canada
  More Information

Additional Information:
Publications:
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.

ClinicalTrials.gov Identifier: NCT00227760     History of Changes
Other Study ID Numbers: CDR0000446080, PMH-PHL-039, NCI-7128
Study First Received: September 26, 2005
Last Updated: September 5, 2012
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Kidney Neoplasms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Maleic acid
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013