Conditions: Adenocarcinoma of the Colon Adenocarcinoma of the Rectum Recurrent Colon Cancer Recurrent Rectal Cancer Stage IV Colon Cancer Stage IV Rectal Cancer
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 10
Healthy volunteers: no

Brief summary:
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.

Detailed description:
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.

Arms:
arm 1: Patients receive oral AZD0530 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Interventions: intervention 1: saracatinib intervention 2: laboratory biomarker analysis
Intervention descriptions: intervention 1: Given orally intervention 2: Correlative studies

Protocol document: