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
Case Comprehensive Cancer Center
With
OBJECTIVES: * Determine the maximum tolerated dose and dose-limiting toxicity of irinotecan and capecitabine when given in combination with a fixed dose of oxaliplatin in patients with advanced solid tumors. * Determine the pharmacokinetic parameters of this regimen in these patients. * Determine the antitumor response of these patients treated with this regimen. OUTLINE: This is a dose-escalation study of irinotecan and capecitabine. Patients receive oxaliplatin IV over 2 hours followed 1 hour later by irinotecan IV over 30 minutes once weekly for 4 weeks. Patients also receive oral capecitabine twice daily on days 1-5 weekly for 4 weeks. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of irinotecan and capecitabine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. PROJECTED ACCRUAL: Approximately 9-15 patients will be accrued for this study within 9-15 months.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
