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Phase I Study of Gemcitabine (Gemzar) and UFT/Leucovorin (NCT00003925)

National Cancer Institute (NCI)
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 combining gemcitabine, fluorouracil-uracil and leucovorin in treating patients who have advanced cancer that has not responded to previous therapy.
  • Drug: gemcitabine hydrochloride
    • Drug: leucovorin calcium
      • Drug: tegafur-uracil
        Ages eligible for Study
        18 Years and older
        Genders eligible for Study
        Accepts Healthy Volunteers

        - Determine the maximum tolerated doses of gemcitabine, fluorouracil-uracil (UFT), and leucovorin calcium in patients with advanced refractory cancer.

        - Assess the toxicity of this combination regimen in this patient population.

        - Evaluate this regimen in terms of response rate, response duration, and overall survival in these patients.

        OUTLINE: This is a dose escalation study of gemcitabine and fluorouracil-uracil.

        Patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15. Patients receive oral leucovorin calcium immediately followed by oral fluorouracil-uracil (UFT) three times a day on days 1-21. Courses are repeated every 28 days. Treatment continues in the absence of disease progression or unacceptable toxicity.

        Cohorts of 3-6 patients receive escalating doses of gemcitabine and UFT until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicities.

        PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study.

        1 locations

        United States (1)
        • Barbara Ann Karmanos Cancer Institute
          Not specified
          Detroit, Michigan, United States, 48201-1379
        30 April, 1998
        04 April, 2013
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