Finding studies
Finding studies
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Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
National Cancer Institute (NCI)
PRIMARY OBJECTIVES: I. Determine whether thalidomide alters the pharmacokinetics of irinotecan in patients with advanced solid tumors. II. Determine whether irinotecan alters the pharmacokinetics of thalidomide in these patients. III. Determine the toxicity of this regimen in these patients. IV. Determine the observed antitumor response in patients treated with this regimen. OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 treatment arms. Arm I: Patients receive irinotecan IV over 90 minutes on days 1 and 22 and oral thalidomide once daily on days 15-28. Arm II: Patients receive irinotecan as in arm I and oral thalidomide once daily on days -6 to 7. All patients undergo disease re-evaluation at 6 weeks. Patients with stable or responsive disease may receive additional courses comprising irinotecan IV on day 1 and oral thalidomide once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
