Phase II Study of Six Hours Low Dose Gemcitabine Plus Cisplatin in the Treatment for Advanced Pleural Mesothelioma

Primary Objective:

• Evaluate the response of treatment with gemcitabine at a dose of 250 mg/m2SC in 6-hour infusion combined with cisplatin in patients with unresectable malignant mesothelioma.

Secondary Objectives:

• Evaluate the toxicity of the combination of gemcitabine at a dose of 250 mg/m2 infused over 6 hours in with cisplatin patients with unresectable malignant mesothelioma.
• Evaluate the progression free survival (PFS) and overall survival (OS) in patients with unresectable MM treated with this combination.

Eligibility Criteria

Inclusion Criteria:

• Histologic diagnosis of pleural mesothelioma
• Multidisciplinary assessment and considered not a candidate for resection
• Karnofsky > = 70 or ECOG < 2
• Adequate hematologic, renal and hepatic function

Exclusion Criteria:

• Superior vena cava syndrome, severe bone pain or CNS metastasis
• Not candidate for chemotherapy (poor functional status: ECOG >2)
• The patient refuses to participate