Recurrent Rectal Cancer Clinical Trial
Official title:
A Phase II Study of Oxaliplatin in Children With Recurrent Solid Tumors
This phase II trial is studying how well oxaliplatin works in treating young patients with recurrent solid tumors that have not responded to previous treatment. Drugs used in chemotherapy, such as oxaliplatin, work in different ways to stop tumor cells from dividing so they stop growing or die.
OBJECTIVES:
I. Determine the response rate in children with recurrent or refractory solid tumors treated
with oxaliplatin.
II. Determine the cumulative toxicity of this drug in these patients. III. Determine the
pharmacokinetic profile of this drug in these patients. IV. Determine time to progression
and overall survival of patients treated with this drug.
V. Correlate the extent of oxaliplatin exposure with response in these patients.
OUTLINE: This is a multicenter study. Patients are stratified according to disease type.
Patients receive oxaliplatin IV over 2 hours on day 1. Treatment repeats every 21 days for
up to 17 courses in the absence of disease progression or unacceptable toxicity.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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