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Sponsored by: |
National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00436956 |
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 |
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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 |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Study of AZD2171 in Metastatic Androgen Independent Prostate Cancer |
Estimated Enrollment: | 37 |
Study Start Date: | May 2007 |
Estimated Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed prostate cancer
Progressive, androgen-independent disease
Radiographic evidence of disease that has continued to progress despite hormonal agents
PATIENT CHARACTERISTICS:
No uncontrolled intercurrent illness including, but not limited to, any of the following:
PRIOR CONCURRENT THERAPY:
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 |
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 |
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 |
stage IV prostate cancer recurrent prostate cancer |
Prednisone Prostatic Diseases Genital Neoplasms, Male Urogenital Neoplasms |
Genital Diseases, Male Prostatic Neoplasms Recurrence |
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 |