Clinical Trial: A Phase II Study of AZD2171 in Breast Cancer Stage IV (10006202)

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase II Study of AZD2171 in Breast Cancer Stage IV (10006202)

Brief Summary: AZD2171 (cediranib maleate) 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. This phase II trial is studying how well AZD2171 works in treating patients with refractory stage IV breast cancer

Detailed Summary:

PRIMARY OBJECTIVES:

I. Evaluation of the fraction of patients with increased levels of circulating endothelial cells after 3 weeks of treatment with AZD2171.

II. Estimation of the objective response rate (ORR = CR + PR) among patients with refractory breast cancer receiving AZD2171.

SECONDARY OBJECTIVES:

I. Estimation of the response/stable disease rate (RSDR = CR + PR + SD). II. Characterization of the toxicity associated with AZD2171 in this cohort of patients.

III. Analyses to correlate serial quantification of circulating endothelial cells and circulating tumor cells with traditional clinical endpoints including RR and TTP.

IV. Develop pharmacodynamic measures of AZ2171 activity based on monocyte count and VEGFR-1 phosphorylation within monocytes.

OUTLINE: This is a nonrandomized, open-label, multicenter study.

Patients receive oral AZD2171 once daily for 42 days. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed for 3 months.

PROJECTED ACCRUAL: A total of 26 patients will be accrued for this study.

Sponsor: National Cancer Institute (NCI)

Current Primary Outcome:

• Fraction of Patients With Increased Levels of Circulating Endothelial Cells [ Time Frame: After 3 weeks of treatment ]
  An exact 95% confidence interval (CI) will be calculated for the CEC response rate. With 26 patients, this CI will be no wider than 40% (e.g., if 13 of 26 patients respond, the CI is 30% to 70%).
• Objective Response Rate (ORR = CR + PR) Classified According to RECIST Criteria [ Time Frame: Up to 7 years ]
  RECIST 1.0 Criteria

Original Primary Outcome:

Current Secondary Outcome: Response/Stable Disease Rate Defined as the Percentage of Patients Demonstrating CR + PR + SD [ Time Frame: 12 weeks ]

Original Secondary Outcome:

Information By: National Cancer Institute (NCI)

Dates:
Date Received: October 25, 2005
Date Started: September 2005
Date Completion:
Last Updated: December 3, 2015
Last Verified: November 2013