Primary Outcome Measure:
- Response rate [ Time Frame: After 6 cycles of chemotherapy (each cycle is 21 days ) ] [ Designated as safety issue: No ]
Tumor response will be evaluated after the third (initial evaluation response) and the sixth (confirmation of initial response) chemotherapy cycle according to the modified Response Evaluation Criteria in Solid Tumors. Patients will be assigned to one of following groups: complete response (CR), Partial response (PR), Stable disease (SD) and progressive disease (PD).
Secondary Outcome Measures:
- Progression free survival (PFS) [ Time Frame: one year ] [ Designated as safety issue: No ]
- Progression-free survival (PFS) time is defined as the time from day 1 of chemotherapy to the day of documented disease progression or to death from any cause
- Overall survival (OS) [ Time Frame: one year ] [ Designated as safety issue: No ] Time is defined as the time from day 1 of chemotherapy to death from any cause.
- Estimation of treatment related toxicity [ Time Frame: during the chemotherapy period, average duration 4 months ] [ Designated as safety issue: No ]
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Hematologic (anemia, neutropenia, and thrombocytopenia) and non hematologic (nausea/vomiting, alopecia and nephrotoxicity) toxicities will be evaluated according to the National Cancer Institute-Common Toxicity Criteria. The worst degree of toxicity experienced throughout the treatment is used for the analysis. Toxicities of grade 2 or higher will be considered as clinically relevant.
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Eligibility Criteria
- Inclusion Criteria:
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- Patients with histologically confirmed Malignant Pleural Mesothelioma
- Age of 18 years or more.
- First-line chemotherapy with Gemcitabine in combination with a platinum agent
- Exclusion Criteria:
- History of prior malignancy.
- Pregnancy or lactation or any other reason preventing him from taking Gemcitabine/platinum combination (AST more than 2.5* Upper Limit of Normal or Serum bilirubin more than 1.5* Upper Limit of Normal)
