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Phase I Clinical Study of Every Three Week Irinotecan With Oral Capecitabine Given Twice Daily for Two Weeks Out of Three in Patients With Gastrointestinal and Other Solid Malignancies (NCT00003867)

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of irinotecan and capecitabine in treating patients who have solid tumors that have not responded to previous treatment.
  • Drug: capecitabine
    • Drug: irinotecan hydrochloride
      Ages eligible for Study
      18 Years and older
      Genders eligible for Study
      All
      Accepts Healthy Volunteers
      No
      OBJECTIVES: I. Determine the maximum tolerated dose and toxic effects of irinotecan and oral capecitabine in patients with gastrointestinal or other solid tumors. II. Characterize the relationship at the recommended phase II dose between thymidine synthase and thymidine phosphorylase expression and tumor response and/or toxic effects in these patients.

      OUTLINE: This is a dose escalation study. Patients receive oral capecitabine twice daily every twelve hours for 14 days, and IV irinotecan over 30 minutes once every 3 weeks beginning on day 1. Treatment continues for at least 2 courses in the absence of disease progression or unacceptable toxicity. The dose of capecitabine and irinotecan is escalated in cohorts of 3-6 patients until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6 patients experience dose limiting toxicity.

      PROJECTED ACCRUAL: Approximately 25-30 patients will be accrued for this study.

      1 locations

      United States (1)
      • Albert Einstein Comprehensive Cancer Center
        Bronx, New York, United States, 10461
      Status:
      unknown
      Type:
      Interventional
      Phase:
      Start:
      28 February, 1999
      Updated:
      22 July, 2008
      Participants:
      30
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