Recurrent Rectal Cancer Clinical Trial
Official title:
Phase II Study of AZD0530 (NSC 735464) in Patients With Previously Treated Metastatic Colorectal Cancer
This phase II trial is studying how well AZD0530 works in treating patients with previously treated metastatic colon cancer or rectal cancer. AZD0530 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.
PRIMARY OBJECTIVES:
I. Determine the progression-free survival (PFS) at 4 months in metastatic colorectal
carcinoma patients receiving daily doses of AZD0530.
SECONDARY OBJECTIVES:
I. Evaluate the objective response rate (RR) and overall survival (OS) of patients with
metastatic colorectal cancer who are treated with AZD0530.
II. In patients who consent, both blood and tissue samples will be collected for laboratory
correlates. Assess in a preliminary manner the association between correlative markers and
the potential downstream effects of AZD0530 on IL-8, VEGF, specific Src-regulated markers in
focal adhesions, adherens junctions, and angiogenesis on clinical outcome in pre- and
post-treatment tumor samples.
OUTLINE:
Patients receive oral AZD0530 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 35 patients will be accrued for this study.
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