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AZD2171 and Prednisone in Treating Patients With Metastatic Androgen-Independent Prostate Cancer
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), November 2008
Sponsored by: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00436956
  Purpose

RATIONALE: AZD2171 and prednisone 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 how well giving AZD2171 together with prednisone works in treating patients with metastatic androgen-independent prostate cancer.


Condition Intervention Phase
Prostate Cancer
Drug: cediranib maleate
Drug: prednisone
Procedure: dynamic contrast-enhanced magnetic resonance imaging
Procedure: gene expression analysis
Procedure: laboratory biomarker analysis
Procedure: mutation analysis
Procedure: pharmacological study
Phase II

MedlinePlus related topics: Cancer Prostate Cancer
Drug Information available for: Prednisone Cediranib
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: A Phase II Study of AZD2171 in Metastatic Androgen Independent Prostate Cancer

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

Primary Outcome Measures:
  • 6-month progression-free survival [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Prostate-specific antigen [ Designated as safety issue: No ]
  • Pharmacokinetics [ Designated as safety issue: No ]

Estimated Enrollment: 37
Study Start Date: May 2007
Estimated Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • Determine if treatment with AZD2171 in combination with predinsone is associated with a 30% 6-month probability of progression-free survival in patients with metastatic androgen-independent prostate cancer.

Secondary

  • Determine the overall response rate and overall survival of patients treated with this regimen.
  • Assess survival, from the time of prostate-specific antigen (PSA) progression, in the absence of radiological or clinical progression.
  • Assess the biologic effect of this regimen in these patients.
  • Determine the pharmacokinetics of this regimen in these patients.
  • Evaluate the PSA response rate in patients treated with this regimen.

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

Blood samples are collected at baseline and periodically during course 1 of study therapy. Samples are evaluated for pharmacokinetics and tumor and gene expression alterations. Patients undergo a dynamic contrast-enhanced MRI at baseline and on days 2, 28, and 56 for the evaluation of tumor vascularity.

After the completion of study treatment, patients are followed periodically.

PROJECTED ACCRUAL: A total of 37 patients will be accrued for this study.

  Eligibility

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

DISEASE CHARACTERISTICS:

  • Histologically confirmed prostate cancer

    • Metastatic disease
    • Progressive, androgen-independent disease

      • Radiographic evidence of disease that has continued to progress despite hormonal agents

        • Patients on flutamide must have disease progression at least 4 weeks after withdrawal
        • Patients on bicalutamide or nilutamide must have disease progression at least 6 weeks after withdrawal
      • Progressive disease requires that a measurable lesion is expanding, new lesions have appeared, and/or that prostate-specific antigen is continuing to rise on successive measurements
  • Must have received prior docetaxel for androgen-independent prostate cancer
  • Concurrent gonadotropin-releasing hormone agonists or antagonists required for patients without bilateral surgical castration
  • No known brain metastases

PATIENT CHARACTERISTICS:

  • ECOG performance status (PS) 0-2 Karnofsky PS 60-100%
  • Life expectancy > 3 months
  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Hemoglobin ≥ 8 g/dL
  • Bilirubin ≤ 1.5 times upper limit of normal (ULN) (unless due to clinical Gilbert's syndrome)
  • AST and ALT ≤ 2.5 times ULN
  • Creatinine ≤ 1.5 times ULN OR creatinine clearance > 40 mL/min
  • Urine protein ≤ +1 on two consecutive dipsticks taken no less than 1 week apart
  • Blood pressure < 140/90 mm Hg
  • Fertile patients must use effective contraception during and for 3 months after completion of study participation
  • No other invasive malignancies within the past 5 years except nonmelanoma skin cancer or noninvasive bladder cancer
  • No mean QTc > 470 msec (with Bazett's correction)
  • No history of familial long QT syndrome
  • No uncontrolled intercurrent illness including, but not limited to, any of the following:

    • Hypertension
    • Ongoing or active infection
    • Symptomatic congestive heart failure
    • Unstable angina pectoris
    • Cardiac arrhythmia
    • Psychiatric illness or social situation that would limit compliance

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • Recovered from prior therapy, including surgery
  • At least 4 weeks since prior agents not approved by the FDA
  • At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C), radiotherapy, or major surgery
  • Concurrent bisphosphonates allowed for patients with known bone metastases
  • No concurrent grapefruit juice
  • No concurrent antiretroviral therapy for HIV-positive patients
  • No other concurrent anticancer agents or therapies
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00436956

Locations
United States, Maryland
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office Recruiting
Bethesda, Maryland, United States, 20892-1182
Contact: Clinical Trials Office - Warren Grant Magnusen Clinical Center     888-NCI-1937        
Sponsors and Collaborators
Investigators
Study Chair: William D. Figg, PharmD National Cancer Institute (NCI)
Principal Investigator: William Dahut, MD National Cancer Institute (NCI)
Investigator: Marcia L. Mulquin, RN NCI - Medical Oncology Branch
  More Information

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

Study ID Numbers: CDR0000529000, NCI-07-C-0059, NCI-P6964
Study First Received: February 15, 2007
Last Updated: December 11, 2008
ClinicalTrials.gov Identifier: NCT00436956  
Health Authority: Unspecified

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

Study placed in the following topic categories:
Prednisone
Prostatic Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms
Recurrence

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Neoplasms
Neoplasms by Site
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Hormones
Glucocorticoids
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009