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A Phase I, Maximum Tolerated Dose (MTD) Trial to Determine the Safety and Pharmacokinetics of Chronic Oral Administration of Farnesyl Transferase Inhibitor R115777 in Combination With Gemcitabine in Subjects With Advanced Incurable Cancer (NCT00003707)

National Cancer Institute (NCI)
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. PURPOSE: Phase I trial to study the effectiveness of combining R115777 with gemcitabine in treating patients with advanced cancer.
  • Drug: gemcitabine hydrochloride
    • Drug: tipifarnib
      Ages eligible for Study
      18 Years and older
      Genders eligible for Study
      All
      Accepts Healthy Volunteers
      No
      OBJECTIVES:

      - Determine the maximum tolerated dose and dose limiting toxicities of tipifarnib in combination with gemcitabine in patients with advanced cancer.

      - Investigate potential pharmacokinetic interactions between tipifarnib and gemcitabine in these patients.

      - Determine the efficacy of this regimen in patients with measurable or evaluable disease.

      - Evaluate the quality of life of these patients.

      OUTLINE: This is a dose-escalation study of tipifarnib.

      Patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15 and oral tipifarnib every 12 hours beginning on day 2. Treatment continues every 4 weeks in the absence of disease progression or unacceptable toxicity.

      Cohorts of 3-6 patients each receive escalating doses of tipifarnib until the maximum tolerated dose (MTD) is reached. The MTD is defined as the dose at which fewer than one third of the patients experience dose limiting toxicity.

      Quality of life is assessed before treatment, on day 22 of each course, and at the end of treatment.

      PROJECTED ACCRUAL: A maximum of 40 patients will be accrued for this study.

      1 locations

      United States (1)
      • San Antonio Cancer Institute
        San Antonio, Texas, United States, 78229-3264
      Status:
      completed
      Type:
      Interventional
      Phase:
      Start:
      30 September, 1998
      Updated:
      25 June, 2012
      Participants:
      22
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