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

Phase 1
18 Years
Open (Enrolling)
Melanoma (Skin)

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Trial Information

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.

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically proven unresectable or metastatic melanoma

PATIENT CHARACTERISTICS: Age: Over 18 Performance status: ECOG 0-2 Life expectancy:
Greater than 3 months Hematopoietic: Hemoglobin greater than 10 g/dL WBC greater than
3,000/mm3 Platelet count greater than 100,000/mm3 Hepatic: Bilirubin less than 1.8 mg/dL
AST less than 3 times upper limit of normal (ULN) Alkaline phosphatase less than 3 times
ULN No hepatitis B Renal: Creatinine less than 1.4 mg/dL OR Creatinine clearance greater
than 50 mL/min Cardiovascular: No New York Heart Association class II cardiac disease
Pulmonary: No pulmonary disease requiring oxygen therapy Other: Not pregnant Fertile
patients must use effective contraception during study and for 3 months following No
concurrent serious nonmalignant disease No AIDS No uncontrolled infection No uncontrolled
diabetes No medical condition that will interfere with taking oral temozolomide

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior biologic therapy
and recovered No concurrent biologic therapy Chemotherapy: At least 4 weeks since prior
chemotherapy and recovered No prior carboplatin and temozolomide No other concurrent
chemotherapy Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since prior
radiotherapy and recovered At least 3 weeks since prior palliative radiotherapy No
concurrent radiotherapy Surgery: No concurrent surgery to tumor Other: No other concurrent
investigational agent

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Gordon J.S. Rustin, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Mount Vernon Cancer Centre at Mount Vernon Hospital


United States: Federal Government

Study ID:




Start Date:

October 1998

Completion Date:

Related Keywords:

  • Melanoma (Skin)
  • stage IV melanoma
  • recurrent melanoma
  • Melanoma