Phase II multicenter study with Fotemustine and Temozolomide modulation in patients with metastatic melanoma (MM) - Phase II multicenter study with Fotemustine and Temozolomide in MM

Conditions: Patients with metastatic melanoma non pre-treated for advanced disease
MedDRA version: 12.1Level: LLTClassification code 10027481Term: Metastatic melanoma

Registration Number: EUCTR2009-016487-36-IT

Lead Sponsor: GOIM GRUPPO ONCOLOGICO MERIDIONALE

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

?Histologically confirmed, unresectable, stage IV metastatic melanoma; ?Measurable disease (based on RECIST criteria) including patients with brain stabilized metastases; ?No prior treatments for metastatc disease ?Patients of at list 18 years of age; ?Performance status of 0-2 (ECOG); ?Adequate hepatic and bone function (Hb >10 g/dL, ANC >2000/uL, PLT >100.000/uL; AST and ALT <1.5 x UNL, alcaline phosphatase, <5 x UNL; creatinina <1.25 x UNL); ?Life expectancy of at least 12 weeks; ?Writen informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

?History of prior malignancies within the past 5 years other than carcinoma in situ of the cervix and non-melanomatous skin cancers; ?History of myocardial infarction within 12 months prior to randomization; ?History of psychological disorders might not permit the patient to complete the study or sign the informed consent; ?Active infections; ?Use od concomitant experimental drugs.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Overall response;Secondary Objective: -Toxicity profile; -Inpact on Quality of life; -Time to progression; -Response duration; -Overall survival;Primary end point(s): To avuate if the pre-treament with low dose of Temozolomide is able to increase the activity of Fotemustine inducing a O6-alkylguanine-DNA alkyltransferase depletion in MM patients

Secondary Outcome Measures

Name	Time	Method

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Recruitment & Eligibility

Study & Design

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