A Phase II Study of Oxaliplatin in Relapsed and Refractory Non-Hodgkin's Lymphoma
I. Determine the response rate to oxaliplatin in patients with relapsed or refractory
II. Determine the treatment-related toxicity of this drug in these patients.
OUTLINE: This is a multicenter study. Patients are stratified according to histologic
subtype (indolent vs aggressive).
Patients receive oxaliplatin IV over 2 hours on day 1. Treatment repeats every 21 days for a
maximum of 6 courses in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A maximum of 72 patients will be accrued for this study within 2-3 years.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Using a Simon's two-stage model.
Up to 6 years
M.D. Anderson Cancer Center
United States: Food and Drug Administration
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