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Phase I (Tumour Site Specific) Study of Carboplatin and Temozolomide in Patients With Advanced Melanoma (NCT00003747)

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 carboplatin and temozolomide in treating patients who have unresectable or metastatic melanoma.
  • Drug: carboplatin
    • Drug: temozolomide
      Ages eligible for Study
      18 Years and older
      Genders eligible for Study
      All
      Accepts Healthy Volunteers
      No
      OBJECTIVES: I. Determine the maximum tolerated dose of carboplatin and temozolomide in patients with unresectable or metastatic melanoma. II. Assess the safety of this cytotoxic combination in this patient population. III. Assess the preliminary evidence of efficacy of this combination in these patients.

      OUTLINE: This is an open label, dose escalation study. Patients receive oral temozolomide once daily on days 1-5. Carboplatin IV is administered over 1 hour on day 1. Courses are repeated every 28 days. Treatment continues for a maximum of 6 courses in the absence of toxicity and disease progression. Sequential dose escalation of carboplatin with a fixed dose of temozolomide is followed by sequential dose escalation of carboplatin at a higher fixed dose of temozolomide. Dose escalation in cohorts of 3-6 patients each continues 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 toxic effects. If the combination treatment with carboplatin given on day 1 of temozolomide therapy is more toxic than anticipated, then the study is repeated with carboplatin given on day 5 of temozolomide therapy. Patients are followed at least every 2 months.

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

      1 locations

      United Kingdom (1)
      • Mount Vernon Hospital
        Not specified
        Northwood, England, United Kingdom, HA6 2RN
      Status:
      unknown
      Type:
      Interventional
      Phase:
      Start:
      30 September, 1998
      Updated:
      18 September, 2013
      Participants:
      30
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