Recurrent Rectal Cancer Clinical Trial
Official title:
Phase II Study of Sorafenib/Avastin® as Salvage Therapy in Patients With Metastatic Colorectal Cancer
This phase II trial is studying how well giving sorafenib together with bevacizumab works in treating patients with metastatic colorectal cancer. Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Sorafenib and bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving sorafenib together with bevacizumab may kill more tumor cells
PRIMARY OBJECTIVES:
I. Evaluate proportion of patients who are progression-free at 3 months (in historic
comparison with results for single-agent bevacizumab in ECOG 3200).
SECONDARY OBJECTIVES:
I. Response rate (RR) II. Overall survival (OS) III. Safety IV. Feasibility
OUTLINE: This is a multicenter study.
Patients receive sorafenib tosylate orally twice daily on days 1-5 and 8-12 and bevacizumab
IV over 30-90 minutes on day 1. Courses repeat every 14 days in the absence of disease
progression or unacceptable toxicity. Blood samples are collected at baseline and then
periodically during study treatment for laboratory biomarker and pharmacogenetic studies.
After completion of study treatment, patients are followed periodically for up to 2 years.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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