A Phase II Study of Oxaliplatin in Relapsed and Refractory Non-Hodgkin's Lymphoma
OBJECTIVES:
I. Determine the response rate to oxaliplatin in patients with relapsed or refractory
non-Hodgkin's lymphoma.
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.
Interventional
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Response rate
Using a Simon's two-stage model.
Up to 6 years
No
Anas Younes
Principal Investigator
M.D. Anderson Cancer Center
United States: Food and Drug Administration
NCI-2012-02363
NCT00006473
September 2000
Name | Location |
---|---|
M D Anderson Cancer Center | Houston, Texas 77030 |