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

Published: April 11, 2014

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
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