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A Phase II Study Utilizing Gemcitabine and Cisplatinum in Patients With Renal Cell Carcinoma (NCT00003928)

National Cancer Institute (NCI)
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: This phase II trial is studying how well gemcitabine and cisplatin work in treating patients with metastatic kidney cancer.
  • Drug: cisplatin
    Cisplatin IV over 60 minutes on day 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
    • Drug: gemcitabine hydrochloride
      Gemcitabine IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
      Ages eligible for Study
      18 Years and older
      Genders eligible for Study
      All
      Accepts Healthy Volunteers
      No
      OBJECTIVES:

      - Assess the response rate of patients with metastatic renal cell carcinoma treated with gemcitabine and cisplatin.

      - Assess toxicity of this regimen in these patients.

      OUTLINE: Patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15 and cisplatin IV over 60 minutes on day 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

      Patients are followed every 4 months.

      PROJECTED ACCRUAL: Approximately 29-38 patients will be accrued for this study.

      1 locations

      United States (1)
      • Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
        Cleveland, Ohio, United States, 44106-5065
      Status:
      completed
      Type:
      Interventional
      Phase:
      Start:
      31 December, 1998
      Updated:
      08 June, 2010
      Participants:
      32
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