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Carboplatin and Temozolomide in Treating Patients With Unresectable or Metastatic Melanoma

NCT ID: NCT00003747

Last Updated: 2013-09-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

1998-10-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Melanoma (Skin)

Keywords

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stage IV melanoma recurrent melanoma

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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carboplatin

Intervention Type DRUG

temozolomide

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mount Vernon Cancer Centre at Mount Vernon Hospital

OTHER

Sponsor Role lead

Principal Investigators

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Gordon J.S. Rustin, MD

Role: STUDY_CHAIR

Mount Vernon Cancer Centre at Mount Vernon Hospital

Locations

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Mount Vernon Hospital

Northwood, England, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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MTVERNHOSP-OCT1998

Identifier Type: -

Identifier Source: secondary_id

EU-98069

Identifier Type: -

Identifier Source: secondary_id

CDR0000066867

Identifier Type: -

Identifier Source: org_study_id