A Phase II Study Of PS-341 In Patients With Metastatic Colorectal Cancer
OBJECTIVES:
- Determine the efficacy of bortezomib, in terms of response rate and stable disease
rate, in patients with recurrent or metastatic colorectal cancer.
- Determine the toxicity of this drug in these patients.
- Determine the time to progression and response duration in patients treated with this
drug.
- Determine whether there is a relationship between levels of transcription factors NF
kappa B and HIF-1 alpha and clinical outcome in patients treated with this drug.
OUTLINE: This is an open-label study.
Patients receive bortezomib IV on days 1, 4, 8, and 11. Courses repeat every 3 weeks in the
absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 21-41 patients will be accrued for this study within 2-4
months.
Interventional
Masking: Open Label, Primary Purpose: Treatment
Amit M. Oza, MD
Study Chair
Princess Margaret Hospital, Canada
United States: Federal Government
CDR0000258488
NCT00052507
January 2003
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