Phase I (Tumour Site Specific) Study of Carboplatin and Temozolomide in Patients With Advanced Melanoma
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.
Primary Purpose: Treatment
Gordon J.S. Rustin, MD
Mount Vernon Cancer Centre at Mount Vernon Hospital
United States: Federal Government